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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2016
TOTAL 510(k)s THIS PERIOD 254
TOTAL WITH SUMMARIES 241
TOTAL WITH STATEMENTS 13
DEVICE: Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated 510(k) NO: K152232(Traditional)
ATTN: Lisa Christo PHONE NO : 913 5771784
10101 Renner Blvd. SE DECISION MADE: 18-NOV-16
Lenexa KS 66219-9275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vonflex S
VERICOM CO., LTD. 510(k) NO: K152615(Traditional)
ATTN: Myung-Hwan Oh PHONE NO : 82 31 4412881
48, Toegyegongdan 1-gil SE DECISION MADE: 03-NOV-16
Chuncheon-Si, KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPNOSPAD
Somnics Inc. 510(k) NO: K152660(Traditional)
ATTN: TSUNG-MIN HSIEH PHONE NO : 886 355 09623190
5F , No.22, Sec. 2, Sheng Yi Road.SE DECISION MADE: 09-NOV-16
Hsinchu County TW 30261 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable High Pressure Injector Syringe
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K152906(Traditional)
ATTN: Wu Feng PHONE NO : 86 510 83771274
NO. 215 XIGANG ROAD, DONGBEITANG SE DECISION MADE: 22-NOV-16
WUXI CN 214191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter A310
AMEMO INC 510(k) NO: K153021(Traditional)
ATTN: HUA XIE PHONE NO : 510 5099680
1154 CADILLAC COURT SE DECISION MADE: 22-NOV-16
MILPITAS CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMASORBPLUS Resorbable Hemostatic Bone Putty
ORTHOCON, INC. 510(k) NO: K153317(Traditional)
ATTN: HOWARD L. SCHRAYER PHONE NO : 609 9249510
1 BRIDGE STREET, SUITE 121 SE DECISION MADE: 30-NOV-16
IRVINGTON NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
Diazyme Laboratories 510(k) NO: K153394(Traditional)
ATTN: Abhijit Datta PHONE NO : 858 4554762
12889 Gregg Court SE DECISION MADE: 18-NOV-16
Poway CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
PROTECT U GUARD, LLC 510(k) NO: K153409(Abbreviated)
ATTN: Brent W. Laartz PHONE NO : 813 8150530
1840 MEASE DRIVE SUITE 319 SE DECISION MADE: 15-NOV-16
Safety Harbor FL 34695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathLoc-SI Joint Fusion System
L&K BIOMED Co., Ltd. 510(k) NO: K153656(Traditional)
ATTN: Yerim An PHONE NO : 82 2 67171985
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 14-NOV-16
Giheung-gu, Yongin-si KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co
Synergeyes, Inc. 510(k) NO: K153714(Abbreviated)
ATTN: Karen Kincade PHONE NO : 760 4769410
5927 PRIESTLY DR SUITE210 SE DECISION MADE: 15-NOV-16
CARLSBAD CA 92008 510(k) STATEMENT
DEVICE: Disposal Lens Cleaning Sheath
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K153773(Traditional)
ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 426 422694
2951 ISHIKAWA-CHO SE DECISION MADE: 22-NOV-16
HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heyman Packing Applicator Set
VARIAN MEDICAL SYSTEMS, INC 510(k) NO: K160045(Traditional)
ATTN: PETER J. CORONADO PHONE NO : 650 4246230
3100 HANSEN WAY SE DECISION MADE: 17-NOV-16
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Charisma
Heraeus Kulzer, LLC (Mitsui Chemic510(k) NO: K160049(Traditional)
ATTN: Jamie Cleveland PHONE NO : 574 2995421
4315 S. Lafayette Blvd SE DECISION MADE: 15-NOV-16
South Bend IN 46614 510(k) STATEMENT
DEVICE: rainbow Shine
GENOSS Co. Ltd. 510(k) NO: K160079(Traditional)
ATTN: Byungsun Kim PHONE NO : 82 70 70988806
1F Gyeonggi R&DB Center/226, 2F, GSE DECISION MADE: 10-NOV-16
Suwon-si KR 443-270 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCodeConnect
3B MEDICAL, INC. 510(k) NO: K160127(Traditional)
ATTN: ALEX LUCIO PHONE NO : 863 2266285
799 Overlook Drive SE DECISION MADE: 10-NOV-16
Winter Haven FL 33884 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
HAGER & MEISINGER GMBH 510(k) NO: K160132(Traditional)
ATTN: Melanie May PHONE NO : 49 02131 2012292
HANSEMANNSTRASSE 10 SE DECISION MADE: 21-NOV-16
NEUSS DE 41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL90 FLEX PLUS
RADIOMETER MEDICAL APS 510(k) NO: K160153(Special)
ATTN: SOEREN BOEGESTRAND PHONE NO : 45 3 8273852
AAKANDEVEJ 21 SE DECISION MADE: 04-NOV-16
BROENSHOEJ DK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-MIND trium
DE GOTZEN S.R.L. 510(k) NO: K160166(Abbreviated)
ATTN: Olivier Balouka PHONE NO : 39 0331 376760
VIA ROMA, 45 SE DECISION MADE: 15-NOV-16
OLGIATE OLONA, IT 21057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intermittent Pneumatic Compression system
DaeSung Maref Co., Ltd 510(k) NO: K160180(Special)
ATTN: Jae-wha Lee PHONE NO : 82 31 4597211
298-24, Gongdan-ro SE DECISION MADE: 03-NOV-16
Gunpo-si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunmed Control Syringes
Sunny Medical Device (Shenzhen) Co510(k) NO: K160190(Traditional)
ATTN: James Qi Zhang PHONE NO : 949 2168838
56 Lehigh Aisle SE DECISION MADE: 10-NOV-16
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSTAAR AdjusteR
SPINAL ACOUSTICS, LLC 510(k) NO: K160278(Traditional)
ATTN: ALBERT A. TORRENCE PHONE NO : 724 7755200
640 FOURTH STREET SE DECISION MADE: 04-NOV-16
BEAVER PA 15009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Sphygmomanometer
Guangdong Biolight Meditech Co., L510(k) NO: K160349(Traditional)
ATTN: Liang Jin PHONE NO :
Innovation First Road, Technical ISE DECISION MADE: 03-NOV-16
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
PRIMED MEDICAL PRODUCTS INC. 510(k) NO: K160361(Traditional)
ATTN: RICHARD R ROY PHONE NO : 1 780 4977600
3RD FLOOR, 1259-91 ST SW. SE DECISION MADE: 04-NOV-16
EDMONTON CA T6X1E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K160421(Traditional)
ATTN: Rafal Chudzik PHONE NO : 480 5256006
1435 North Hayden Road, Suite 100 SE DECISION MADE: 02-NOV-16
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PleurX Peritoneal Catheter System
CareFusion 510(k) NO: K160437(Traditional)
ATTN: Tamara Brey PHONE NO : 847 3629485
75 North Fairway Drive SE DECISION MADE: 03-NOV-16
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCP Bone Putty
BioStructures, LLC 510(k) NO: K160446(Traditional)
ATTN: John Brunelle PHONE NO : 949 5531717
1201 Dove Street, Suite 470 SE DECISION MADE: 07-NOV-16
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calprest NG
EUROSPITAL S.P.A. 510(k) NO: K160447(Traditional)
ATTN: Claudia Brandolin PHONE NO : 39 040 89971
VIA FLAVIA 122 SE DECISION MADE: 10-NOV-16
TRIESTE IT 34147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivo 60
BREAS MEDICAL AB 510(k) NO: K160481(Traditional)
ATTN: Albert Cefalo PHONE NO : 617 3566289
FORETAGSVAGEN 1 SE DECISION MADE: 09-NOV-16
MOLNLYCKE VASTRA GOTALANDS LAN SE510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electronic Pulse Stimulator
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160508(Traditional)
ATTN: Lei Chen PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACH HI-TESE DECISION MADE: 21-NOV-16
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyCHROM ESBL
HARDY DIAGNOSTICS 510(k) NO: K160512(Traditional)
ATTN: ANDRE HSIUNG PHONE NO : 805 3462766
1430 WEST MCCOU LANE SE DECISION MADE: 15-NOV-16
SANTA MARIA CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K160530(Traditional)
ATTN: Mina Cheng PHONE NO : 86 755 61120299
4TH FL, BLDG A, YINGTAILONG INDUSTSE DECISION MADE: 28-NOV-16
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Greiner Holdex
GREINER BIO-ONE NA INC. 510(k) NO: K160532(Traditional)
ATTN: MANFRED ABEL PHONE NO : 704 2617823
4238 CAPITAL DRIVE SE DECISION MADE: 03-NOV-16
MONROE NC 28110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM
PEGA MEDICAL INC. 510(k) NO: K160545(Traditional)
ATTN: Ariel R. Dujovne PHONE NO : 1 450 6885144
1111 AUTOROUTE CHOMEDEY SE DECISION MADE: 23-NOV-16
LAVAL CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDO HOLLOW-FIBRE DIALYZERS
BELLCO Srl 510(k) NO: K160558(Traditional)
ATTN: Giuseppe Tomasini PHONE NO : 0039 0535 29323
via Camurana 1 SE DECISION MADE: 18-NOV-16
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boosting Catheter
QXMEDICAL, LLC 510(k) NO: K160561(Traditional)
ATTN: FERNANDO DI CAPRIO PHONE NO : 651 8422050
2820 PATTON ROAD SE DECISION MADE: 02-NOV-16
ROSEVILLE MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TroClose1200
GORDIAN SURGICAL LTD. 510(k) NO: K160564(Traditional)
ATTN: ZVI PEER PHONE NO : 972 72 2607079
17TH TCHELET ST. SE DECISION MADE: 17-NOV-16
KARMIEL IL 2161401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRWire Guide Wire
NANO4IMAGING GMBH 510(k) NO: K160594(Traditional)
ATTN: CHRISTOPH R. MANEGOLD PHONE NO : 49 241 56528261
PAUWELSSTR. 17 SE DECISION MADE: 22-NOV-16
AACHEN DE 52074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
PMS Medikal Ambalaj Sanayi ve Tica510(k) NO: K160595(Traditional)
ATTN: Derya Dikici PHONE NO : 90 324 2387042
Karaduvar Mah Serbest Bolge, 11 caSE DECISION MADE: 18-NOV-16
Mersin TR 33020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ENFit Syringe
Medline Industries, Inc. 510(k) NO: K160642(Traditional)
ATTN: Stephanie Blair PHONE NO : 847 6433690
One Medline Place SE DECISION MADE: 29-NOV-16
Mundelein IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorSens
CorSens Medical Ltd. 510(k) NO: K160656(Traditional)
ATTN: Yoram Levy PHONE NO : 972 3 6070306
3 Azrieli Center Triangular Tower SE DECISION MADE: 21-NOV-16
Tel Aviv IL 6702301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)
EVOLUTION SPINE, LLC 510(k) NO: K160663(Traditional)
ATTN: Ashton Kouzbari PHONE NO : 214 6828536
4225 OFFICE PARKWAY SE DECISION MADE: 16-NOV-16
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR NEXT ONE Blood Glucose Monitoring System
ASCENSIA DIABETES CARE 510(k) NO: K160682(Traditional)
ATTN: Roger Sonnenburg PHONE NO : 574 2563441
430 S. BEIGER ST. SE DECISION MADE: 17-NOV-16
Mishawaka IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
Y. JACOBS MEDICAL, INC 510(k) NO: K160705(Traditional)
ATTN: HUI JUN PARK PHONE NO : 82 254 60715
6F SANGKYUNG BLDG. 669 SEOLLEUNG-RSE DECISION MADE: 23-NOV-16
SEOUL KR 135-830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
COVIDIEN 510(k) NO: K160718(Traditional)
ATTN: Timothy Holwick PHONE NO : 303 3052345
6135 Gunbarrel Avenue SE DECISION MADE: 14-NOV-16
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carriere Motion Clear Class II
ORTHO ORGANIZERS, INC. 510(k) NO: K160720(Traditional)
ATTN: COLLEEN BOSWELL PHONE NO : 760 4488730
1822 ASTON AVENUE SE DECISION MADE: 28-NOV-16
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOLINE touchECG
CARDIOLINE S.p.A 510(k) NO: K160746(Traditional)
ATTN: Emanuele Ercoli PHONE NO : 039 0463 850125
VIA LINZ 19-20-21 SE DECISION MADE: 02-NOV-16
Z.I. SPINI DI GARDOLO IT 38121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DW-1C
DONGWON MEDICAL CO., LTD. 510(k) NO: K160761(Traditional)
ATTN: Gil Haeng Lee PHONE NO : 82 624 306521
201-HO, 35, SAAM-RO 340BEON-GIL GWSE DECISION MADE: 22-NOV-16
Gwangju KR 62328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
DIAZYME LABORATORIES 510(k) NO: K160762(Traditional)
ATTN: ABHIJIT DATTA PHONE NO : 858 4554762
12889 GREGG COURT SE DECISION MADE: 21-NOV-16
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RODO Abutment System
RODO MEDICAL, INC 510(k) NO: K160786(Traditional)
ATTN: Michael Parsons PHONE NO : 408 2457636
690 SARATOGA AVE., SUITE 100 SE DECISION MADE: 21-NOV-16
SAN JOSE CA 95129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AmorChem Titanium Porous Fixation Device
AmorChem Holdings, Inc. 510(k) NO: K160791(Traditional)
ATTN: KEVIN MCBRIDE PHONE NO : 514 8495451
1, Westmount Square SE DECISION MADE: 15-NOV-16
Montreal CA H3Z 2P9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DuoCem
COLTENE/WHALEDENT AG 510(k) NO: K160800(Traditional)
ATTN: Silke Wallaschek PHONE NO : 0041 71 7575852
FELDWIESENSTR. 20 SE DECISION MADE: 16-NOV-16
ALTSTATTEN CH 9450 510(k) STATEMENT
DEVICE: Well Lead Extraction Bag
WELL LEAD MEDICAL CO., LTD. 510(k) NO: K160801(Traditional)
ATTN: HAN GUANG YUAN PHONE NO : 86 20 84758878
C-4 # JINHU INDUSTRIAL ESTATE, HUASE DECISION MADE: 29-NOV-16
GUANGZHOU CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U&U Enteral Syringe
U&U MEDICAL TECHNOLOGY CO.,LTD 510(k) NO: K160855(Traditional)
ATTN: BLACK WANG PHONE NO : 0086 1390 2471751
DONGZHOU VILLAGE, HENGYSHANQIAO SE DECISION MADE: 22-NOV-16
CHANGZHOU CN 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PolyPlex Wound Dressing
GLOBAL HEALTH SOLUTIONS, LLC 510(k) NO: K160872(Traditional)
ATTN: Bradley Burnam PHONE NO : 706 8441025
1360 REDMOND CIRCLE SE DECISION MADE: 23-NOV-16
Rome GA 30165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tablo Console
OUTSET MEDICAL, INC. 510(k) NO: K160881(Traditional)
ATTN: LESLIE TRIGG PHONE NO : 650 2694483
1830 BERING DRIVE SE DECISION MADE: 15-NOV-16
SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CXI Support Catheter
COOK INCORPORATED 510(k) NO: K160884(Special)
ATTN: Daniel J. Corbin PHONE NO : 812 3392235 104018
750 DANIELS WAY SE DECISION MADE: 22-NOV-16
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Initia Total Hip System & BIOCERAM AZUL(R) HEAD
KYOCERA Medical Corporation 510(k) NO: K160895(Traditional)
ATTN: Cheryl Hastings PHONE NO : 574 5274220
Uemura Nissei Bldg., 3-3-31 MiyahaSE DECISION MADE: 01-NOV-16
Yodogawa-ku JP 532-0003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
CS Medical LLC 510(k) NO: K160921(Traditional)
ATTN: Kendall Ashe PHONE NO : 919 2559472
2179 East Lyon Station Road SE DECISION MADE: 03-NOV-16
Creedmoor NC 27522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDAPT Anteverted Cemented Liner
SMITH & NEPHEW, INC. 510(k) NO: K160923(Traditional)
ATTN: KIM PHAN PHONE NO : 901 8003175
7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 17-NOV-16
CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amendia Interbody Fusion Devices
AMENDIA, INC. 510(k) NO: K160924(Traditional)
ATTN: Bruce Hooper PHONE NO : 877 7553329
1755 WEST OAK PARKWAY SE DECISION MADE: 08-NOV-16
MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Discovery NM 750b Bopsy
GE Healthcare 510(k) NO: K160933(Traditional)
ATTN: Efrat Hartog-David PHONE NO : 972 4 8563666 805
4 Hayozma Street SE DECISION MADE: 18-NOV-16
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Disposable Transflectance Forehead Sensor
Masimo Corporation 510(k) NO: K160940(Traditional)
ATTN: Marguerite Thomlinson PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 23-NOV-16
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xsert Lumbar Expandable Interbody System
X-SPINE SYSTEMS, INC. 510(k) NO: K160959(Traditional)
ATTN: KRISS ANDERSON PHONE NO : 937 8478400
452 ALEXANDERSVILLE RD. SE DECISION MADE: 17-NOV-16
MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inclusive Abutments
PRISMATIK DENTALCRAFT, INC. 510(k) NO: K160979(Traditional)
ATTN: SHELLY HARRIS PHONE NO : 949 4402629
2212 DUPONT DRIVE, SUITE P SE DECISION MADE: 04-NOV-16
IRVINE CA 92612 510(k) STATEMENT
DEVICE: SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
Adhezion Biomedical, LLC 510(k) NO: K161011(Traditional)
ATTN: Richard Jones PHONE NO : 610 2417191
One Meridian Boulevard, Suite 1B02SE DECISION MADE: 08-NOV-16
Wyomissing PA 19610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnoSEAL Hemostatic Pad
InnoTherapy Inc. 510(k) NO: K161013(Traditional)
ATTN: Moon Sue Lee PHONE NO : 82 2 69591338
Ace Hightechcity2,25, Seonyu-ro 13SE DECISION MADE: 29-NOV-16
Seoul KR 07282 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell AmpliScan
Cadwell Industries, Inc. 510(k) NO: K161027(Traditional)
ATTN: John Cadwell PHONE NO : 509 7356481
909 N. Kellog St. SE DECISION MADE: 08-NOV-16
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
SHEN WEI (USA), INC. 510(k) NO: K161074(Traditional)
ATTN: CHERYL BAILEY-KROLL PHONE NO : 510 4298692
33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 17-NOV-16
UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FONA Pan/Ceph
FONA SRL 510(k) NO: K161131(Traditional)
ATTN: ELISA GUSBERTI PHONE NO : 39 02 45712171
VIA GALILEO GALILEI 11 SE DECISION MADE: 03-NOV-16
ASSAGO IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea CT Dual Energy Image View
VITAL IMAGES, INC. 510(k) NO: K161157(Traditional)
ATTN: Alexis Erazo PHONE NO : 952 4879774
5850 OPUS PARKWAY SITE 300 SE DECISION MADE: 03-NOV-16
Minnetonka MN 55343-4414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanova Interference Screw
NANOVA BIOMATERIALS INC. 510(k) NO: K161174(Traditional)
ATTN: ANDREW RITTS PHONE NO : 573 8756682
3806 MOJAVE CT SE DECISION MADE: 03-NOV-16
COLUMBIA MO 65202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renovo Life Small Bone IM Nail System
Renovo Life LLC 510(k) NO: K161254(Traditional)
ATTN: Harold Crowder PHONE NO : 704 2244136
1104 Spruce Street SE DECISION MADE: 07-NOV-16
Belmont NC 28012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN Low Profile Bone Screws
SMITH & NEPHEW, INC. 510(k) NO: K161264(Special)
ATTN: ALLISON CHAN PHONE NO : 901 3991098
1450 E. BROOKS ROAD SE DECISION MADE: 23-NOV-16
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ConvertX Nephroureteral Stent System
BRIGHTWATER MEDICAL 510(k) NO: K161277(Traditional)
ATTN: BOB SMOUSE PHONE NO : 1 650 2108100
816 W. BENNETT CT. SE DECISION MADE: 22-NOV-16
DUNLAP IL 61525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LenSX Laser System
ALCON LABORATORIES, INC. 510(k) NO: K161288(Traditional)
ATTN: JAMES ARGANDA PHONE NO : 949 5057038
20511 LAKE FOREST DR SE DECISION MADE: 16-NOV-16
LAKE FOREST CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solution Set for Epidural Use
BAXTER HEALTHCARE CORPORATION 510(k) NO: K161323(Third Party - Traditional)
ATTN: Tiffany Lin PHONE NO : 224 2704343
32650 N. WILSON ROAD SE DECISION MADE: 30-NOV-16
ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LipiFlow Thermal Pulsation System
TEARSCIENCE, INC. 510(k) NO: K161357(Special)
ATTN: Christy Coleman PHONE NO : 919 4594815
5151 MCCRIMMON PARKWAY SUITE 250 SE DECISION MADE: 04-NOV-16
MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Durepair Dura Regeneration Matrix
Medtronic Neurosurgery 510(k) NO: K161370(Traditional)
ATTN: Manas Lele PHONE NO : 805 5718956
125 Cremona Drive SE DECISION MADE: 02-NOV-16
Goleta CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nunchaku
FCI (FRANCE CHIRURGIE INSTRUMENTAT510(k) NO: K161373(Traditional)
ATTN: THIERRY FETICK PHONE NO : 33 153 989898
20-22 RUE LOUIS ARMAND SE DECISION MADE: 03-NOV-16
PARIS FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: joimax Electrosurgical Instruments
JOIMAX GMBH 510(k) NO: K161378(Traditional)
ATTN: WOLFGANG RIES PHONE NO : 49 072 1255140
AMALIENBADSTR. 41 RAUMFABRIK 61 SE DECISION MADE: 02-NOV-16
KARLSRUHE DE 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
ALCON LABORATORIES, INC. 510(k) NO: K161391(Traditional)
ATTN: Sherri Lakota PHONE NO : 817 6155472
6201 SOUTH FREEWAY SE DECISION MADE: 30-NOV-16
FORT WORTH TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compass Cast and MAP
CENTURION MEDICAL PRODUCTS CORPORA510(k) NO: K161408(Traditional)
ATTN: MATTHEW K. PRICE PHONE NO : 517 5465400 1135
100 CENTURION WAY SE DECISION MADE: 22-NOV-16
WILLIAMSTON MI 48895 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes MAXFRAME Multi-Axial Correction System
SYNTHES USA, LLC 510(k) NO: K161417(Traditional)
ATTN: STACEY BONNELL PHONE NO : 610 7195895
1301 GOSHEN PARKWAY SE DECISION MADE: 10-NOV-16
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimplECG
Nanowear Inc. 510(k) NO: K161431(Traditional)
ATTN: Venkatesh Varadan PHONE NO : 718 6374815
53 Boerum Place Suite 3F SE DECISION MADE: 30-NOV-16
Brooklyn NY 11201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulia Diabetes Management Companion
VOLUNTIS S.A. 510(k) NO: K161433(Traditional)
ATTN: RAFFI KRIKORIAN PHONE NO : 33 141 383920
58, AVENUE DE WAGRAM SE DECISION MADE: 09-NOV-16
Paris FR 75017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Temporary Snap Abutment
Nobel Biocare AB 510(k) NO: K161435(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
GENESYS SPINE 510(k) NO: K161438(Traditional)
ATTN: BRIAN BERGERON PHONE NO : 512 3817071
1250 CAPITAL OF TEXAS OF HIGHWAY SSE DECISION MADE: 08-NOV-16
AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Propeller Sensor Model 2015-E
Reciprocal Labs Corporation 510(k) NO: K161454(Traditional)
ATTN: Taylor Mahan-Rudolph PHONE NO : 608 2510470
634 W. Main Street, Suite 102 SE DECISION MADE: 01-NOV-16
Madison WI 53703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XEN Glaucoma Treatment System
Allergan, Inc. 510(k) NO: K161457(Traditional)
ATTN: Barbara A. Niksch PHONE NO : 949 4500250 236
26970 Aliso Viejo Parkway, Suite 2SE DECISION MADE: 21-NOV-16
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Walk-O2-Bout
ESSEX INDUSTRIES, INC. 510(k) NO: K161472(Traditional)
ATTN: RUSS JACOBSMEYER PHONE NO : 314 3388723
7700 GRAVOIS SE DECISION MADE: 18-NOV-16
ST. LOUIS MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YO Home Sperm Test
MEDICAL ELECTRONIC SYSTEMS, LTD 510(k) NO: K161493(Traditional)
ATTN: MARCIA DEUTSCH PHONE NO : 972 463 73981
ALON HATAVOR ST.20 ZONE 6 SE DECISION MADE: 08-NOV-16
CAESAREA IND. PARK IL 38900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
Siemens Healthcare Diagnostics, In510(k) NO: K161494(Traditional)
ATTN: Laura J. Duggan PHONE NO : 302 6317654
500 GBC Drive, PO Box 6101 MS 514 SE DECISION MADE: 15-NOV-16
Newark DE 19711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eUnity
Client Outlook Inc. 510(k) NO: K161515(Special)
ATTN: Christie Eby PHONE NO : 519 3423049 206
103 Bauer Place, Suite #3 SE DECISION MADE: 15-NOV-16
Waterloo CA N2L6B5 510(k) STATEMENT
DEVICE: MatrixRIB Fixation System
SYNTHES (USA) PRODUCTS LLC 510(k) NO: K161590(Traditional)
ATTN: THOMAS SHEA PHONE NO : 610 7195679
1301 GOSHEN PARKWAY SE DECISION MADE: 03-NOV-16
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Partial Knee System
BIOMET, INC. 510(k) NO: K161592(Traditional)
ATTN: Nicole J. Meredith PHONE NO : 574 3773718
56 EAST BELL DR. SE DECISION MADE: 03-NOV-16
WARSAW IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical BioTy® Nanotopography Trauma Screw
TYBER MEDICAL LLC 510(k) NO: K161597(Traditional)
ATTN: MARK F. SCHENK PHONE NO : 610 84906045
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 16-NOV-16
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRT Revision Hip System
Encore Medical, L.P. 510(k) NO: K161610(Traditional)
ATTN: TEFFANY HUTTO PHONE NO : 512 8346255
9800 METIRC BLVD SE DECISION MADE: 09-NOV-16
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatomical Shoulder Domelock Dome centric
ZIMMER GMBH 510(k) NO: K161620(Traditional)
ATTN: ROBERTO TOMMASINI PHONE NO : 41 58 8548264
SULZERALLEE 8 SE DECISION MADE: 01-NOV-16
WINTERTHUR CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
B. Braun Medical Inc. 510(k) NO: K161623(Traditional)
ATTN: Nancy Skocypec PHONE NO : 610 2664962___
901 Marcon Blvd SE DECISION MADE: 10-NOV-16
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicrO2 OSA Device with Micro-Recorder
MICRODENTAL, Inc. 510(k) NO: K161624(Traditional)
ATTN: David Kuhns PHONE NO : 925 8038643
5601 Arnold Rd. SE DECISION MADE: 07-NOV-16
Dublin CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAS Pulse(TM) Ultrasonic Therapy
Bonutti Research, Inc. 510(k) NO: K161628(Abbreviated)
ATTN: Patrick G. Balsmann PHONE NO : 217 3423412 5106
P.O. Box 1367 SE DECISION MADE: 10-NOV-16
Effingham IL 62401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPS CaseDesigner
NOBEL BIOCARE AB 510(k) NO: K161634(Traditional)
ATTN: CHARLEMAGNE CHUA PHONE NO : 714 2824800 7830
VASTRA HAMNGATAN 1 SE DECISION MADE: 10-NOV-16
GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lipogems System
Lipogems International SpA 510(k) NO: K161636(Traditional)
ATTN: CARLO RUSSO PHONE NO : 39 02 37072408
viale Bianca Maria 24 SE DECISION MADE: 04-NOV-16
Milano IT 20129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDTRAP Graft Preparation System
MEDOS INTERNATIONAL SARL 510(k) NO: K161638(Traditional)
ATTN: Jeffrey Dzialo PHONE NO :
CHEMIN-BLANC 38 SE DECISION MADE: 07-NOV-16
LE LOCLE NEUCHATEL CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
DIAZYME LABORATORIES 510(k) NO: K161646(Traditional)
ATTN: ABHIJIT DATTA PHONE NO : 858 4554762
12889 GREGG COURT SE DECISION MADE: 04-NOV-16
POWAY CA 92130 510(k) STATEMENT
DEVICE: Virtu C Spinal Implant System
Met 1 Technologies, LLC 510(k) NO: K161649(Traditional)
ATTN: Dan Gerbec PHONE NO : 915 3010834
154 N. Festival Dr., Ste. F SE DECISION MADE: 09-NOV-16
El Paso TX 79912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VLP Wrist Fracture System
SMITH & NEPHEW, INC. 510(k) NO: K161665(Traditional)
ATTN: SAMANTHA STAUBACH PHONE NO : 901 3996132
1450 BROOKS ROAD SE DECISION MADE: 15-NOV-16
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucid Q-PTP / HWA 55
BISON MEDICAL CO., LTD 510(k) NO: K161670(Traditional)
ATTN: SUN WO PHONE NO : 82 286 57121
ACE HIGH-END TOWER 6, 1801 BEOTKKOSE DECISION MADE: 02-NOV-16
GUEM CHEN GU KR 153-789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LacriPro Punctum Plug
LACRIMEDICS, INC. 510(k) NO: K161673(Traditional)
ATTN: REBECCA C. DUTTON PHONE NO : 253 9640360
2620 WILLIAMSON PLACE NW, SUITE 11SE DECISION MADE: 18-NOV-16
DUPONT WA 98245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Therapy Machine
BEIJING ADSS DEVELOPMENT CO., LTD 510(k) NO: K161692(Traditional)
ATTN: GAO YURONG PHONE NO : 86 10 83625120
F6, XIANDO BLDG., JINYUAN RD. 36, SE DECISION MADE: 16-NOV-16
BEIJING CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
AAP IMPLANTATE AG 510(k) NO: K161696(Traditional)
ATTN: RENI SCHALLER PHONE NO : 49 307 50190
LORENZWEG 5 SE DECISION MADE: 23-NOV-16
BERLIN DE 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
STERILMED, INC. 510(k) NO: K161700(Traditional)
ATTN: Reuben Lawson PHONE NO : 949 7898545
5010 CHESHIRE PARKWAY STE. 2 SE DECISION MADE: 21-NOV-16
Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
AAP IMPLANTATE AG 510(k) NO: K161703(Traditional)
ATTN: RENI SCHALLER PHONE NO : 49 307 50190
LORENZWEG 5 SE DECISION MADE: 04-NOV-16
BERLIN DE 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K161708(Special)
ATTN: XIE QIONGYU PHONE NO : 086 0755 26710795
2/F, M-7 SINOSTEEL BUILDING, MAQUESE DECISION MADE: 22-NOV-16
NANSHAN DISTRICT, SHENZHEN CN 518510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-contact Forehead Thermometer
Shenzhen Dongdixin Technology Co.,510(k) NO: K161735(Traditional)
ATTN: Siping Yuan PHONE NO : 086 075 527652471
No. 3 Building Xilibaimang XushengSE DECISION MADE: 17-NOV-16
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K161738(Traditional)
ATTN: PAUL LIU PHONE NO : 886 2 66258188
6F, NO.127, WUGONG 2ND RD., WUGU DSE DECISION MADE: 10-NOV-16
NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-SPECT Scanner, D-SPECT L Scanner
Spectrum Dynamics Medical Ltd 510(k) NO: K161740(Traditional)
ATTN: Igor Naroditsky PHONE NO : 972 54 4384386
22 Bareket St SE DECISION MADE: 04-NOV-16
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Tornier, Inc. 510(k) NO: K161742(Traditional)
ATTN: Laurie Lewandowski PHONE NO : 612 7704038
10801 Nesbitt Avenue South SE DECISION MADE: 15-NOV-16
Bloomington MN 55340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
aap Implantate AG 510(k) NO: K161747(Traditional)
ATTN: Reni Schaller PHONE NO : 0049 30 75019193
Lorenzweg 5 SE DECISION MADE: 22-NOV-16
Berlin DE D-12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hoffman LRF System
STRYKER GMBH 510(k) NO: K161753(Traditional)
ATTN: PAUL NELSON PHONE NO : 201 8315691
325 CORPORATE DRIVE SE DECISION MADE: 15-NOV-16
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
Smith & Nephew, Inc. 510(k) NO: K161763(Traditional)
ATTN: Bradley Heil PHONE NO : 901 3996339
150 Minuteman Rd. SE DECISION MADE: 22-NOV-16
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCAS 3 Chest Compression System
Jolife AB 510(k) NO: K161768(Traditional)
ATTN: Malin Melander PHONE NO : 46 46 2865000
Scheelevagen 17, Ideon Science ParSE DECISION MADE: 09-NOV-16
Lund SE 223 70 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lenstec LC Injection system
LENSTEC INC. 510(k) NO: K161776(Traditional)
ATTN: JIMMY CHACKO PHONE NO : 727 5712272
1765 COMMERCE AVE.N. SE DECISION MADE: 29-NOV-16
ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ToeTac™ 10° Hammertoe Fixation System
RESTORE SURGICAL LLC DBA INSTRATEK510(k) NO: K161778(Traditional)
ATTN: JEFF SEAVEY PHONE NO : 281 8908020
15200 MIDDLEBROOK DR., SUITE G SE DECISION MADE: 22-NOV-16
HOUSTON TX 77058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
MedSource International, LLC 510(k) NO: K161779(Traditional)
ATTN: Laura Riggen PHONE NO : 952 2418325
401 Norex Drive SE DECISION MADE: 03-NOV-16
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Univers Revers Shoulder Prosthesis System
ARTHREX, INC. 510(k) NO: K161782(Traditional)
ATTN: David L Rogers PHONE NO : 239 6435553 71924
1370 CREEKSIDE BLVD. SE DECISION MADE: 21-NOV-16
NAPLES FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM ESSENZA
Siemens Medical Solutions USA, Inc510(k) NO: K161795(Special)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
65 Valley Stream Parkway SE DECISION MADE: 18-NOV-16
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NNR06 Multi-Purpose Solution
Bausch & Lomb Incorporated 510(k) NO: K161819(Traditional)
ATTN: Glenn Davies PHONE NO : 585 3388215
1400 North Goodman Street SE DECISION MADE: 25-NOV-16
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
Immunodiagnostic Systems Ltd 510(k) NO: K161831(Traditional)
ATTN: Mick Henderson PHONE NO : 440 191 5190660
10 Didcot Way, Boldon Business ParSE DECISION MADE: 15-NOV-16
Boldon GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One Drop Blood Glucose Monitoring System
AgaMatrix, Inc. 510(k) NO: K161834(Special)
ATTN: David Olsen PHONE NO : 603 8934191
7C Raymond Ave. SE DECISION MADE: 30-NOV-16
Salem NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatStrip Xpress Glucose Hospital Meter System
Nova Biomedical Corporation 510(k) NO: K161856(Special)
ATTN: Paul W. MacDonald PHONE NO : 781 6473700
200 Prospect Street SE DECISION MADE: 15-NOV-16
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ThermoPro
Zimmer MedizinSysteme GmbH 510(k) NO: K161862(Traditional)
ATTN: Armin Petraschka PHONE NO : 49 731 9761140
Junkersstrasse 9 SE DECISION MADE: 14-NOV-16
Neu-Ulm DE 89231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
Stryker GmbH 510(k) NO: K161863(Traditional)
ATTN: Saad Attiyah PHONE NO : 201 8315655
Bohnackerweg 1 SE DECISION MADE: 23-NOV-16
2545 Selzach CH CH 2545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pacel Flow Directed Pacing Catheter
St. Jude Medical 510(k) NO: K161873(Traditional)
ATTN: Blair Schwartz PHONE NO : 651 7562706
14901 DeVeau Place SE DECISION MADE: 22-NOV-16
Minnetonka MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HC Primer
Shofu Dental Corporation 510(k) NO: K161891(Traditional)
ATTN: Mauro Malzyner PHONE NO : 760 7363277
1225 Stone Drive SE DECISION MADE: 21-NOV-16
San Marcos CA 92078 510(k) STATEMENT
DEVICE: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
CHANGZHOU XIN NENG YUAN MEDICAL ST510(k) NO: K161905(Traditional)
ATTN: Boping Ma PHONE NO : 86 519 88830515
NO.51, SHUISHAN RD, ZHONGLOU ECONOSE DECISION MADE: 17-NOV-16
Changzhou CN 213023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQvitals Zone
Midmark Corporation 510(k) NO: K161909(Traditional)
ATTN: Asad Abu-Tarif PHONE NO : 800 6248950
690 Knox Street, Suite 100 SE DECISION MADE: 17-NOV-16
Torrance CA 90502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS Small Fragment Plating System
ADVANCED ORTHOPAEDIC SOLUTIONS, I510(k) NO: K161913(Special)
ATTN: ALEX BHASKARLA PHONE NO : 310 5339966
3203 KASHIWA STREET SE DECISION MADE: 04-NOV-16
TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwiftNINJA Microcatheter
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K161921(Traditional)
ATTN: LUKE MEIDELL PHONE NO : 801 2084623
1600 WEST MERIT PARKWAY SE DECISION MADE: 04-NOV-16
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Terang Nusa Sdn Bhd 510(k) NO: K161932(Traditional)
ATTN: Robert Hill PHONE NO : 0060 977 47171
1 Jalan 8, Pengkalan Chepa 2, InduSE DECISION MADE: 28-NOV-16
Kota Bharu MY 16100 510(k) STATEMENT
DEVICE: Avance Foam Dressing Kit - XL
MOLNLYCKE HEALTH CARE, US LLC 510(k) NO: K161935(Traditional)
ATTN: MEGAN BEVILL PHONE NO : 470 3750049
5550 PEACHTREE PARKWAY, SUITE 500SE DECISION MADE: 04-NOV-16
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avance Abdominal Dressing Kit
Molnlycke Health Care US, LLC 510(k) NO: K161939(Traditional)
ATTN: Megan Bevill PHONE NO : 470 3750049
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 17-NOV-16
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
SHANDONG BAISHENG MEDICAL PRODUCTS510(k) NO: K161944(Traditional)
ATTN: CECILY SHENG PHONE NO : 86 536 7510508
11 Longshan Rd, Wolong Industy ParSE DECISION MADE: 21-NOV-16
Linqu CN 262600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avance Gauze Dressing Kits
MOLNLYCKE HEALTH CARE, US LLC 510(k) NO: K161948(Traditional)
ATTN: MEGAN BEVILL PHONE NO : 470 3750049
5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 03-NOV-16
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraShape System
Syneron Medical Ltd. 510(k) NO: K161952(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 73 2442200
Tavor Building, Industrial Zone, PSE DECISION MADE: 07-NOV-16
Yokneam Illit IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W&H Implantmed SI-1015 incl. Accessories
W&H DENTALWERK BURMOOS GMBH 510(k) NO: K161957(Traditional)
ATTN: ANJA LINDNER PHONE NO : 0043 6274 6236397
IGNAZ-GLASER-STRABE 53 SE DECISION MADE: 23-NOV-16
BUERMOOS AT 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences LLC 510(k) NO: K161962(Traditional)
ATTN: Jennifer Wilbur PHONE NO : 949 7564436
One Edwards Way SE DECISION MADE: 28-NOV-16
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicrUs
TELEMED 510(k) NO: K161968(Traditional)
ATTN: Yury Sokolov PHONE NO : 370 5 2106272
Dariaus ir Gireno str.42 SE DECISION MADE: 03-NOV-16
Vilnius LT LT-02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLENDERTONE® Connect Abs, Type 570
Bio-Medical Research Ltd. 510(k) NO: K161974(Special)
ATTN: Anne-Marie Keenan PHONE NO : 353 91 774316
Parkmore Business Park West SE DECISION MADE: 01-NOV-16
Galway IE H91 NHT7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AirFit N20
ResMed Ltd 510(k) NO: K161978(Traditional)
ATTN: Kim Kuan Lee PHONE NO : 61 2 88841000
1 Elizabeth Macarthur Drive SE DECISION MADE: 17-NOV-16
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leva® Anterior Interbody System
Spine Wave, Inc. 510(k) NO: K161993(Traditional)
ATTN: Sanja Jahr PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 22-NOV-16
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aixplorer
SUPERSONIC IMAGINE 510(k) NO: K161999(Traditional)
ATTN: LAURENCE HERMITTE PHONE NO : 33 442 992424
Les Jardins de La Duranne-bat E & SE DECISION MADE: 16-NOV-16
AIX-EN-PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay
ZDi, Solutions, LLC 510(k) NO: K162002(Traditional)
ATTN: Zachary A. Dutton PHONE NO : 865 8097283
800 S Gay St, STE 714 SE DECISION MADE: 01-NOV-16
Knoxville TN 37909 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate Anatomic Shoulder System
ENCORE MEDICAL, L.P 510(k) NO: K162024(Traditional)
ATTN: DESIREE WELLS PHONE NO : 512 8346302
9800 METRIC BLVD. SE DECISION MADE: 21-NOV-16
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelProcera HT ML FCZ Bridge
Nobel Biocare AB 510(k) NO: K162043(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 22-NOV-16
Goteborg SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc 510(k) NO: K162050(Traditional)
ATTN: Shruti Jayakumar PHONE NO : 925 4742516
4698 Willow Road SE DECISION MADE: 21-NOV-16
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
STRYKER CORPORATION 510(k) NO: K162062(Traditional)
ATTN: BECKY DITTY PHONE NO : 269 3893434
4100 E MILHAM AVE SE DECISION MADE: 01-NOV-16
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Small Fragment Plating System
SMITH & NEPHEW, INC. 510(k) NO: K162078(Traditional)
ATTN: SAMANTHA STAUBACH PHONE NO : 901 3996132
1450 BROOKS ROAD SE DECISION MADE: 18-NOV-16
MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-CAT FLX V series / KaVo 3D eXam+ V series
IMAGING SCIENCES INTERNATIONAL 510(k) NO: K162085(Traditional)
ATTN: Ruth Pui PHONE NO : 267 9541479
1910 NORTH PENN RD. SE DECISION MADE: 10-NOV-16
HATFIELD PA 19454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolv Model BP7000 Upper Arm Blood Pressure Monitor
OMRON HEALTHCARE, INC. 510(k) NO: K162092(Traditional)
ATTN: RENEE THORNBOROUGH PHONE NO : 847 2475626
1925 WEST FIELD COURT SE DECISION MADE: 22-NOV-16
LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
YTY INDUSTRY (MANJUNG) SDN. BHD., 510(k) NO: K162095(Traditional)
ATTN: Punitha Samy PHONE NO : 60 5 6792288
Lot 1422-1424, Batu 10 Lekir SE DECISION MADE: 02-NOV-16
Sitiawan MY 32020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InTRAkit
Medtronic Vascular 510(k) NO: K162097(Traditional)
ATTN: Nisarg Shah PHONE NO : 978 7396632
37A Cherry Hill Drive SE DECISION MADE: 17-NOV-16
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Avantofit, MAGNETOM Skyrafit
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K162102(Traditional)
ATTN: JOHN URTZ PHONE NO : 610 4486002
40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 22-NOV-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
CHOICE SPINE, LP 510(k) NO: K162103(Traditional)
ATTN: KIM FINCH PHONE NO : 865 2463333
400 Erin Drive SE DECISION MADE: 23-NOV-16
KNOXVILLE TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (Blue)
NAM VIET GLOVE JOINT STOCK COMPANY510(k) NO: K162113(Traditional)
ATTN: OOI LOON SENG PHONE NO : 84 083 5147788
HAMLET 7, PHUOC BINH COMMUNE LONG SE DECISION MADE: 07-NOV-16
HO CHI MINH VN 815300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System
L&K BIOMED CO.,LTD. 510(k) NO: K162136(Traditional)
ATTN: Yerim An PHONE NO : 82 2 67171985
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
GIHEUNG-GU, YONGIN-SI KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allura Xper R9
PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K162148(Abbreviated)
ATTN: Jeanette Becker PHONE NO : 31 611 621238
VEENPLUIS 4-6 SE DECISION MADE: 23-NOV-16
BEST NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xario 200 Diagnostic Ultrasound System V5.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162155(Traditional)
ATTN: PAUL BIGGINS PHONE NO : 714 6697808
1385 SHIMOISHIGAMI SE DECISION MADE: 01-NOV-16
OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Preference Elite Pedicle Screw System
AMEDICA CORPORATION 510(k) NO: K162160(Traditional)
ATTN: Shanna Ryan PHONE NO : 855 8393500
1885 W 2100 S SE DECISION MADE: 18-NOV-16
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barrier Supreme Sterilization Wrapper
Standard Textile Co., Inc. 510(k) NO: K162162(Traditional)
ATTN: Bradley J. Bushman PHONE NO : 513 7619255 2455
One Knollcrest Drive SE DECISION MADE: 04-NOV-16
Cincinnati OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraShape System
SYNERON MEDICAL LTD 510(k) NO: K162163(Traditional)
ATTN: Ruthie Amir PHONE NO : 972 732 442200
TAVOR BUILDING, INDUSTRIAL ZONE, PSE DECISION MADE: 17-NOV-16
Yokneam Illit IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Viet Glove Corporation 510(k) NO: K162175(Traditional)
ATTN: PHAM NGOC THANH PHONE NO : 84 0650 591220
Cau Sat Hamlet, Lai Hung Commune BSE DECISION MADE: 21-NOV-16
Bau Bang Province VN 510(k) STATEMENT
DEVICE: Vantage Galan 3T, MRT-3020, V4.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K162183(Traditional)
ATTN: PAUL BIGGINS PHONE NO : 714 6697808
1385 SHIMOISHIGAMI SE DECISION MADE: 25-NOV-16
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVILAS Laser System
OD-OS GMBH 510(k) NO: K162191(Traditional)
ATTN: WINFRIED TEIWES PHONE NO : 49 3328 31282100
14513 WARTHESTR. 21 SE DECISION MADE: 22-NOV-16
TELTOW DE 14513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GFS Ultimate
PARCUS MEDICAL, LLC 510(k) NO: K162198(Special)
ATTN: PAUL VAGTS PHONE NO : 941 7557965
6423 PARKLAND DR SE DECISION MADE: 18-NOV-16
SARASOTA FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: touchTymp
MAICO DIAGNOSTICS GMBH 510(k) NO: K162210(Special)
ATTN: UWE LEDWORUSKI PHONE NO : 49 307 0714661
SICKINGENSTR. 70-71 SE DECISION MADE: 16-NOV-16
BERLIN DE 10553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuFit Lateral Plate System
PRECISION SPINE, INC. 510(k) NO: K162211(Traditional)
ATTN: Michael C. Dawson PHONE NO : 973 4557150
5 SYLVAN WAY SUITE 220 SE DECISION MADE: 28-NOV-16
Parsippany NJ 07930 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protek Solo 24 Fr Venous Cannula Set
CARDIAC ASSIST, INC. 510(k) NO: K162214(Traditional)
ATTN: GREG JOHNSON PHONE NO : 412 9637770
240 ALPHA DR. SE DECISION MADE: 30-NOV-16
PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
NUANCE MEDICAL, LLC 510(k) NO: K162218(Traditional)
ATTN: MARC LIEBERMAN PHONE NO : 760 5854849
5931 Sea Lion Place, Suite 113 SE DECISION MADE: 22-NOV-16
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
DIO MEDICAL CO., LTD 510(k) NO: K162220(Traditional)
ATTN: SUNG HEE-LEE PHONE NO : 82 31 7763690
101-105 MEGACENTER, SK TECHNOPARK,SE DECISION MADE: 21-NOV-16
SAGIMAKGOL-RO JUNGWON-GU SEONGNAM-510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
WellDoc, Inc 510(k) NO: K162225(Traditional)
ATTN: Michele Livingston PHONE NO : 443 6923100
10221 Wincopin Circle Suite 150 SE DECISION MADE: 22-NOV-16
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ADON HEALTH CO., LTD. 510(k) NO: K162230(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 60526161 9060
NO.3 JIN PING ST, YA AN RD, NANKAISE DECISION MADE: 18-NOV-16
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
CYDEN LIMITED 510(k) NO: K162231(Special)
ATTN: MIKE KIERNAN PHONE NO : 44 1792 485519
TECHNIUM 2, KINGS ROAD SE DECISION MADE: 16-NOV-16
SWANSEA GB SA1 8PJ 510(k) STATEMENT
DEVICE: MOSS 100 Pedicle Screw System
Biedermann Motech GmbH & Co. KG 510(k) NO: K162232(Traditional)
ATTN: Gerd Federle PHONE NO : 49 7720 8510545
Bertha-von-Suttner-Straße 23 SE DECISION MADE: 17-NOV-16
Villingen-Schwenningen DE 78054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProMedTek Model C1400 Shortwave Diathermy Device
PROMEDTEK INC. 510(k) NO: K162240(Traditional)
ATTN: Dan Puchek PHONE NO : 480 3852488
4110 N. SCOTTSDALE RD., SUITE 270 SE DECISION MADE: 17-NOV-16
Scottsdale AZ 85251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FasTouch Fixation System
VIA SURGICAL LTD. 510(k) NO: K162252(Special)
ATTN: OFEK LEVIN PHONE NO : 972 52 6395765
MITZPE KINERET STREET 22/1 SE DECISION MADE: 14-NOV-16
MOSHAV AMIRIM IL 20115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P1145 Dental Restorative
Kerr Corporation 510(k) NO: K162257(Traditional)
ATTN: Mohammad Saad Ansari PHONE NO : 909 9625644
1717 W. Collins Ave SE DECISION MADE: 07-NOV-16
Orange CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium® PL Cage
STRYKER 510(k) NO: K162262(Traditional)
ATTN: Deirdre Jayko PHONE NO : 201 7498339
2 Pearl Court SE DECISION MADE: 09-NOV-16
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CushionCast Moldable Cushions
IZI Medical Products LLC 510(k) NO: K162265(Traditional)
ATTN: Qiang Cao PHONE NO : 443 8262997
5 Easter Court Suite J SE DECISION MADE: 15-NOV-16
Owings Mills MD 21117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senographe Pristina
GE HEALTHCARE 510(k) NO: K162268(Traditional)
ATTN: Gregory Pessato PHONE NO : 33 1 30709316
283 RUE DE LA MINIERE SE DECISION MADE: 03-NOV-16
BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise TKA Guide System
MATERIALISE NV 510(k) NO: K162273(Traditional)
ATTN: OLIVER CLEMENS PHONE NO : 32 163 96280
TECHNOLOGIELAAN 15 SE DECISION MADE: 07-NOV-16
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Diagnostic Mobile X-ray System
SAMSUNG ELECTRONICS CO., LTD. 510(k) NO: K162278(Traditional)
ATTN: CHULSIN KIM PHONE NO : 82 312 007661
129, SAMSUNG-RO, YEONGTONG-GU SE DECISION MADE: 15-NOV-16
SUWON-SI KR 16677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Puritan Fecal Opti-Swab Collection and Transport System
PURITAN MEDICAL PRODUCTS LLC 510(k) NO: K162284(Traditional)
ATTN: MEHDI KARAMCHI PHONE NO : 207 8763311 3284
31 SCHOOL STREET P.O. BOX 149 SE DECISION MADE: 04-NOV-16
GUILFORD ME 04443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reform® POCT System
PRECISION SPINE, INC. 510(k) NO: K162300(Traditional)
ATTN: MICHAEL C. DAWSON PHONE NO : 601 4204244
2050 EXECUTIVE DRIVE SE DECISION MADE: 22-NOV-16
PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XBraid TT Suture Tape
Stryker 510(k) NO: K162310(Traditional)
ATTN: Taylor White PHONE NO : 303 3367285
5670 Greenwood Plaza Blvd., Suite SE DECISION MADE: 10-NOV-16
Greenwood Village CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pirouette 014
ArraVasc Ltd 510(k) NO: K162316(Special)
ATTN: Aoife Donoghue PHONE NO : 353 91 758939 54
2 Ballybrit Business Park SE DECISION MADE: 22-NOV-16
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
ACCESS SCIENTIFIC, LLC 510(k) NO: K162322(Traditional)
ATTN: WALTER CORDIGLIA PHONE NO : 1 858 4800216
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 17-NOV-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018"
Boston Scientific Corporation 510(k) NO: K162350(Special)
ATTN: Ka Zoua Xiong PHONE NO : 763 4942970
One Scimed Place SE DECISION MADE: 04-NOV-16
Maple Grove MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Raycast MammoRx Carbon Fibre Breast Board
Orfit Industries NV 510(k) NO: K162355(Traditional)
ATTN: Eddy Marivoet PHONE NO : 32 0 33262026
9A, VOSVELD SE DECISION MADE: 22-NOV-16
WIJNEGEM BE 2110 510(k) STATEMENT
DEVICE: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
SYNTHES USA PRODUCTS LLC 510(k) NO: K162358(Traditional)
ATTN: Eugene Bang PHONE NO : 508 9773966
325 Paramount Drive SE DECISION MADE: 01-NOV-16
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V30 system, V-Form Handpiece BC Medium applicator
Viora Ltd. 510(k) NO: K162363(Traditional)
ATTN: Stella Raizelman Perry PHONE NO : 972 9 9551344
6 Hagavish Street SE DECISION MADE: 18-NOV-16
Netanya IL 4250706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON® Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K162379(Traditional)
ATTN: Nathaniel Hendricks PHONE NO : 901 3441208
1800 Pyramid Place SE DECISION MADE: 16-NOV-16
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILK Surgical Suture
TELEFLEX MEDICAL, INC 510(k) NO: K162396(Traditional)
ATTN: NATALIE HICHAK PHONE NO : 919 4338049
3015 CARRINGTON MILL BLVD SE DECISION MADE: 23-NOV-16
MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HyperBand
GE Medical Systems, LLC 510(k) NO: K162403(Traditional)
ATTN: Jason Ma PHONE NO : 262 3522892
3200 North Grandview Blvd SE DECISION MADE: 18-NOV-16
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
BECKMAN COULTER, INC. 510(k) NO: K162414(Special)
ATTN: NANCY NADLER PHONE NO : 305 3804191
11800 SW 147TH AVE. SE DECISION MADE: 29-NOV-16
MIAMI FL 33196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna 3D Interbody Fusion System
Benvenue Medical, Inc. 510(k) NO: K162431(Traditional)
ATTN: Jeff Emery PHONE NO : 408 4549300
5403 Betsy Ross Drive SE DECISION MADE: 17-NOV-16
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioInsight Cardiac Mapping System
CARDIOINSIGHT TECHNOLODIES, INC 510(k) NO: K162440(Special)
ATTN: LAURIE LEWANDOWSKI PHONE NO : 612 7704038
11000 CEDAR AVE SUITE 210 SE DECISION MADE: 04-NOV-16
CLEVELAND OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert MRSA NxG
CEPHEID 510(k) NO: K162444(Traditional)
ATTN: SCOTT A. CAMPBELL PHONE NO : 847 2283299
904 CARIBBEAN DRIVE SE DECISION MADE: 23-NOV-16
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPADA Acne-Clearing Blue Light Pen
FOREO INC. 510(k) NO: K162450(Traditional)
ATTN: Davor Soldo PHONE NO : 855 7736736
1525 Pama Lane, Suite 200 SE DECISION MADE: 30-NOV-16
Las Vegas NV 89119 510(k) STATEMENT
DEVICE: Solana HSV 1+2/VZV Assay
QUIDEL CORPORATION 510(k) NO: K162451(Traditional)
ATTN: Ronald H. Lollar PHONE NO : 740 5893373
2005 EAST STATE STREET, SUITE 100 SE DECISION MADE: 28-NOV-16
ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Pan Medical Ltd. 510(k) NO: K162453(Special)
ATTN: Jennie Budding PHONE NO : 44 1452 621621
Barnett Way, Barnwood SE DECISION MADE: 01-NOV-16
Gloucester GB GL4 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Rocket Medical Plc 510(k) NO: K162457(Traditional)
ATTN: Tracy Charlton PHONE NO : 0044 191 4194488 222
2-4 Sedling Road, Wear Industrial SE DECISION MADE: 14-NOV-16
Washington GB NE38 9BZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICUS Separator System, AMICUS Separator System; Refurbished
FRESENIUS KABI USA LLC 510(k) NO: K162462(Traditional)
ATTN: KIM FORCH PHONE NO : 847 5507962
THREE CORPORATE DRIVE SE DECISION MADE: 23-NOV-16
LAKE ZURICH IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LuminScan (TM) Imaging System
MICRO-TECH (NANJING) CO.,LTD. 510(k) NO: K162466(Traditional)
ATTN: Becky Li PHONE NO : 86 25 58646378
NO. 10 GAOKE THIRD ROAD SE DECISION MADE: 29-NOV-16
NANJING CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAD/CAMouflage Milling Block
PRISMATIK DENTALCRAFT, INC. 510(k) NO: K162537(Special)
ATTN: ALIVA DAS PHONE NO : 949 2251249
2212 DUPONT DRIVE, SUITE P SE DECISION MADE: 16-NOV-16
IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K162538(Special)
ATTN: SUSAN FERRIN PHONE NO : 508 6604487
333 CONEY STREET SE DECISION MADE: 17-NOV-16
E. WALPOLE MA 02032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solitaire 2 Revascularization Device
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K162539(Traditional)
ATTN: JENNIFER CORREA PHONE NO : 949 2979563
9775 TOLEDO WAY SE DECISION MADE: 10-NOV-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo Application Software
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162541(Traditional)
ATTN: PATRICIA D. JONES PHONE NO : 610 4486474
40 LIBERTY BOULEVARD 65-1A SE DECISION MADE: 16-NOV-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
SOURCE PRODUCTION AND EQUIPMENT CO510(k) NO: K162573(Traditional)
ATTN: KELLEY RICHARDT PHONE NO : 504 4649471
113 TEAL STREET SE DECISION MADE: 04-NOV-16
SAINT ROSE LA 70087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTEZZA Spinal Stabilization System
OSSO SURGICAL 510(k) NO: K162576(Traditional)
ATTN: Basheer Hassan PHONE NO : 875 5131774
2150 W 43RD ST SE DECISION MADE: 10-NOV-16
Chicago IL 60609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dosimetry Check Version 5 Release 1
MATH RESOLUTIONS, LLC 510(k) NO: K162577(Traditional)
ATTN: WENDEL DEAN RENNER PHONE NO : 410 9979578
5975 GALES LANE SE DECISION MADE: 18-NOV-16
COLUMBIA MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA LISENDO 880
HITACHI, LTD. 510(k) NO: K162583(Traditional)
ATTN: ANGELA VAN ARSDALE PHONE NO : 203 2695088 346
10 FAIRFIELD BLVD SE DECISION MADE: 17-NOV-16
WALLINGFORD CT 06492-5903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuniIQ Digital Radiography System
Suni Medical Imaging, Inc 510(k) NO: K162585(Third Party - Traditional)
ATTN: Al Bettencourt PHONE NO : 408 3370573
6840 Via Del Oro Suite 160 SE DECISION MADE: 04-NOV-16
San Jose CA 95119 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Trex_HD
Natus Medical Incorporated DBA Exc510(k) NO: K162595(Traditional)
ATTN: Sanjay Mehta PHONE NO : 905 8295300
2568 Bristol Circle SE DECISION MADE: 04-NOV-16
Oakville CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I View and Imagen Sensor
TRIDENT S.R.L. 510(k) NO: K162619(Traditional)
ATTN: GIORGIO RIZZO PHONE NO : 39 02 87072380
VIA VERDI 20 SE DECISION MADE: 04-NOV-16
ASSAGO IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESU-1 Electrosurgical Generator
TVA Medical, Inc. 510(k) NO: K162656(Traditional)
ATTN: Katherine Kumar PHONE NO : 612 7165578
7000 Bee Caves Rd., Suite 250 SE DECISION MADE: 10-NOV-16
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViewPoint 6
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K162743(Traditional)
ATTN: TRACEY ORTIZ PHONE NO : 262 6766120
9900 W INNOVATION DRIVE SE DECISION MADE: 22-NOV-16
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pinpoint GT Introducer Needle
C.R. BARD, INC. 510(k) NO: K162769(Special)
ATTN: Jamie Howell PHONE NO : 801 5225465
605 NORTH 5600 WEST SE DECISION MADE: 04-NOV-16
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magma Spark
Formatk Systems Ltd. 510(k) NO: K162781(Special)
ATTN: Ahava Stein PHONE NO : 972 4 8571848
3 Hayozma St. SE DECISION MADE: 09-NOV-16
Tirat Hacarmel IL 3903203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CastleLoc Spinal Fixation System
L&K BIOMED CO., LTD. 510(k) NO: K162801(Special)
ATTN: Yerim An PHONE NO : 82 267 171985
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 03-NOV-16
Giheung-gu, Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Small (4") Roller Pump for the Terumo Advanced Perfusion System 1, Large (6") Roller Pump for the Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K162843(Special)
ATTN: Bryan Hann PHONE NO : 734 7415816
6200 Jackson Road SE DECISION MADE: 17-NOV-16
Ann Arbor MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Raycast High Precision Lung Board Solution
Orfit Industries NV 510(k) NO: K162862(Third Party - Traditional)
ATTN: Raymond Kelly PHONE NO : 203 4007566
9A VOSVELD SE DECISION MADE: 09-NOV-16
WIJNEGEM BE 2110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: dS Small Extremity 16CH 1.5T Coil
INVIVO THERAPEUTICS CORPORATION 510(k) NO: K162863(Third Party - Traditional)
ATTN: Ken Revennaugh PHONE NO : 352 3848590
3545 SW 47th Ave SE DECISION MADE: 07-NOV-16
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Achieve Advance Mapping Catheter
MEDTRONIC INC. 510(k) NO: K162892(Special)
ATTN: HEATHER TAYLOR PHONE NO : 763 5269066
8200 CORAL SEA STREET NE MAIL STOPSE DECISION MADE: 15-NOV-16
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuCath Intravascular Catheter
C.R.BARD, INC. 510(k) NO: K162894(Special)
ATTN: JACOB LEE PHONE NO : 801 5225823
605 N 5600 W SE DECISION MADE: 15-NOV-16
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc. 510(k) NO: K162914(Special)
ATTN: Robin Fuller PHONE NO : 508 6587986
26 Forest Street SE DECISION MADE: 16-NOV-16
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ligasure Blunt Tip, Sealer/Divider, Nano-coated
COVIDIEN 510(k) NO: K162941(Special)
ATTN: CELSO DURAN PHONE NO : 303 5306445
5920 LONGBOW DRIVE SE DECISION MADE: 14-NOV-16
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irix-C Cervical Integrated Fusion System
X-SPINE SYSTEMS, INC. 510(k) NO: K162944(Traditional)
ATTN: KRISS ANDERSSON PHONE NO : 937 8478400 2137
452 ALEXANDERSVILLE RD. SE DECISION MADE: 07-NOV-16
MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TxRx Knee 15 Flare MR Coil 1.5T
Quality Electrodynamics, LLC 510(k) NO: K162966(Traditional)
ATTN: Kathleen Aras PHONE NO : 440 4842964
6655 Beta Drive Suite 100 SE DECISION MADE: 30-NOV-16
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
Inari Medical 510(k) NO: K162970(Special)
ATTN: Eben Gordon PHONE NO : 949 6008433
9272 Jeronimo Rd., Suite 124 SE DECISION MADE: 22-NOV-16
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multix Fusion Max
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K162971(Special)
ATTN: DENISE ADAMS PHONE NO : 610 4486139
40 LIBERTY BOULEVARD, MAIL CODE 65SE DECISION MADE: 22-NOV-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optima XR240amx
GE Medical Systems, LLC 510(k) NO: K162990(Special)
ATTN: Chris Paulik PHONE NO : 262 5482010
3000 N. Grandview Blvd. SE DECISION MADE: 15-NOV-16
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capillus302, Capillus312, Capillus352
CAPILLUS, LLC 510(k) NO: K162994(Special)
ATTN: PATRICIA SCHNOOR PHONE NO : 786 8881874
1715 NW 82nd AVE SE DECISION MADE: 18-NOV-16
MIAMI FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomet Microfixation SternaLock 360 Sternal Closure System
BIOMET MICROFIXATION 510(k) NO: K163007(Special)
ATTN: LAUREN JASPER PHONE NO : 904 7419259
1520 TRADEPORT DRIVE SE DECISION MADE: 23-NOV-16
JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xperius Ultrasound System
PHILIPS HEALTHCARE 510(k) NO: K163020(Third Party - Traditional)
ATTN: SCOTT ZHANG PHONE NO : 425 4877000
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 16-NOV-16
BOTHELL WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Zeramex P6 Dental Implant System
DENTALPOINT AG 510(k) NO: K163043(Special)
ATTN: Viktor Lienhard PHONE NO : 41 44 3883636
Hohlstrasse 614 SE DECISION MADE: 30-NOV-16
Zurich CH 8048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TxRx Knee 15 Flare MR Coil 3.0T
QUALITY ELECTRODYNAMICS, LLC 510(k) NO: K163066(Traditional)
ATTN: Kathleen Aras PHONE NO : 440 4842964
6655 BETA DRIVE SUITE 100 SE DECISION MADE: 29-NOV-16
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E9, LOGIQ E9 XDClear 2.0
GE Medical Systems Ultrasound and 510(k) NO: K163077(Special)
ATTN: Bryan Behn PHONE NO : 414 7214214
9900 Innovation Dr. SE DECISION MADE: 17-NOV-16
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TubeClear Control Box and Clearing Stem
Actuated Medical, Inc. 510(k) NO: K163092(Third Party - Traditional)
ATTN: Thomas L. Cronin PHONE NO : 814 3550003 118
310 Rolling Ridge Drive SE DECISION MADE: 30-NOV-16
Bellefonte PA 16801 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
COVIDIEN 510(k) NO: K163102(Special)
ATTN: KATIE BROWN PHONE NO : 203 4928350
60 MIDDLETON AVE. SE DECISION MADE: 30-NOV-16
NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius Ultrasound System
Clarius Mobile Health Corp. 510(k) NO: K163138(Third Party - Abbreviated)
ATTN: Abhijit Ahir PHONE NO : 1 788 8009975
350 - 3605 Gilmore Way SE DECISION MADE: 30-NOV-16
Burnaby CA V5G 4X5 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PleuraFlow System with FlowGlide
CLEARFLOW, INC. 510(k) NO: K163139(Special)
ATTN: DOV GAL PHONE NO : 714 9165014
1630 S. SUNKIST ST. SUITE E SE DECISION MADE: 30-NOV-16
ANAHEIM CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiLux LED Illuminator
ISOLUX LLC 510(k) NO: K163185(Third Party - Traditional)
ATTN: NIKOLAOS ANDREOULAKIS PHONE NO : 239 5147475
1045 COLLIER CENTER WAY SUITE #6 SE DECISION MADE: 21-NOV-16
NAPLES FL 34110 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Filtek One Bulk Fill Restorative
3M Company 510(k) NO: K163207(Third Party - Traditional)
ATTN: Scott Erickson PHONE NO : 651 7369883
2510 Conway Ave. SE DECISION MADE: 28-NOV-16
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
The post FDA releases November 2016 510(k) clearances appeared first on MassDevice.
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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2016
TOTAL 510(k)s THIS PERIOD 235
TOTAL WITH SUMMARIES 223
TOTAL WITH STATEMENTS 12
DEVICE: EasyMap MAP Catheter
MedFact Engineering GmbH 510(k) NO: K151139(Traditional)
ATTN: Joerg Reinhardt PHONE NO : 49 7621 579820
Hammerstr.3 SE DECISION MADE: 18-OCT-16
Loerrach, Baden-Wurttemberg DE D-510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
SCHUTZ DENTAL GMBH 510(k) NO: K151399(Traditional)
ATTN: ANTJE MAURER PHONE NO : 49 0 60038140
DIESELSTRASSE 5-6 SE DECISION MADE: 24-OCT-16
ROSBACH DE DE 61191 510(k) STATEMENT
DEVICE: KJ Mini Implant System
KJ MEDITECH CO., LTD. 510(k) NO: 
The U.S. Senate voted 94-5 today to pass the 21st Century Cures Act, sending the measure to President Barack Obama, who is likely to sign it into law soon.
Researchers from the Caboolture Hospital in Queensland, Australia found that medical skin glue can be used to hold hospital intravenous lines in place, significantly reducing the risk of infection, pain, blockage or overall failure. The team’s work was 
(Reuters) – These days the average researcher at 
Wound care and regenerative medicine company 
Researchers from the 
St. Jude Medical
