| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K161841 |
01/09/2017 |
D2P |
3D SYSTEMS, INC. |
KIM TORLUEMKE |
| K170754 |
11/21/2017 |
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing |
3M Company, 3M Health Care |
Maria Ruiz |
| K163689 |
01/27/2017 |
3M Clear Tray Aligner |
3M Unitek Corporation |
Yanine Garcia-Quezada |
| K172392 |
11/07/2017 |
Lateral Spinal Truss System (LSTS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K171650 |
11/21/2017 |
Alere Afinion HbA1c and ACR on Afinion 2 analyzer |
Abbott Rapid Diagnostics |
Monica Vallestad |
| K172603 |
11/27/2017 |
Cerafix Dura Substitute |
Acera Surgical, Inc. |
Matthew MacEwan |
| K163254 |
01/18/2017 |
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. |
James A Bonafini |
| K163014 |
01/24/2017 |
AOS Small Bone Nailing System |
Advanced Orthopaedic Solutions, Inc. (AOS) |
Alex Bhaskarla |
| K171254 |
11/16/2017 |
LeEject 2 Dental Syringe and Needle System |
Advanced Technology and Capital, Inc. |
Alexander Lee |
| K170634 |
11/29/2017 |
Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 |
Advanced Vehicle Concepts Ltd. |
Mark Nicholls |
| K162810 |
01/11/2017 |
InSeca ARC Stylus, Aerin Console |
Aerin Medical, Inc. |
Scott Wolf |
| K172032 |
11/20/2017 |
Modulift Vertebral Body Replacement (VBR) System |
Aesculap Implants Systems, Inc. |
Lisa Boyle |
| K173271 |
11/10/2017 |
Aesculap Slim Clip Applier Forceps |
Aesculap, Inc. |
Paul Amudala |
| K172850 |
11/17/2017 |
SterilContainer with PrimeLine Pro Lid |
Aesculap, Inc. |
Lisa Boyle |
| K162805 |
01/10/2017 |
Akros Fibulink Syndesmosis Repair Kit |
Akros Medical |
Charles Horrell |
| K172006 |
11/09/2017 |
Alivio Ventricular Catheter and Flusher System (Alivio System) |
Alcyone Lifesciences. Inc. |
PJ Anand |
| K171816 |
11/16/2017 |
Kardia Band System |
AliveCor, Inc |
Prabhu Raghavan |
| K173522 |
11/30/2017 |
Solanas« Posterior Stabilization System |
Alphatec Spine, Inc |
Natalia Shirina |
| K172253 |
11/21/2017 |
Altus Spine Cervical Interbody Fusion System |
Altus Partners, LLC |
Mark Melton |
| K160976 |
01/25/2017 |
Altus Spine Interbody Fusion System |
ALTUS PARTNERS, LLC |
Claudia Hill |
| K161414 |
01/19/2017 |
Anatomic Total Knee System |
AMPLITUDE |
MIREILLE LEMERY |
| K161270 |
01/04/2017 |
CephSimulation |
ANATOMAGE, INC |
Changxin Xu |
| K170439 |
11/01/2017 |
AN87 Dosimeter |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K170437 |
11/01/2017 |
Sterisheet Sterilization Wrap |
Andersen Sterilizers,Inc. |
William K. Andersen |
| K163141 |
01/06/2017 |
NAMIC ClearaCIL Contrast Injection Lines |
AngioDynamics, Inc. |
Teri Juckett |
| K173016 |
11/15/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| K163107 |
01/23/2017 |
Lifestyles Zero Lubricated Latex Male Condom |
ANSELL HEALTHCARE PRODUCTS, LLC |
Robert Mahler |
| K171886 |
11/15/2017 |
OverStitch SX Endoscopic Suturing System (ESS) |
Apollo Endosurgery Inc |
Maritza Ward |
| K172759 |
11/14/2017 |
Smart External Drain (SED) System |
Aqueduct Critical Care, Inc. |
Thomas Clement |
| K172067 |
11/29/2017 |
One Mum Pumpset |
Ardo medical AG |
Roger Dubach |
| K173319 |
11/16/2017 |
KaVo NOMAD Pro 2 Handheld X-ray System |
Aribex |
Erika Martin |
| K172318 |
11/17/2017 |
Endoform Silver Dermal Template |
Aroa Biosurgery |
Tina O'Brien |
| K163253 |
01/05/2017 |
Arterys Cardio DL |
ARTERYS INC. |
Golnaz Moeini |
| K171365 |
11/07/2017 |
Arthrex Knee Systems |
Arthrex Inc. |
David L. Rogers |
| K170206 |
11/15/2017 |
Arthrex FiberTape Cerclage |
ARTHREX, INC. |
IVETTE GALMEZ |
| K163142 |
01/06/2017 |
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader |
ArthroCare Corporation |
Laura Kasperowicz |
| K162842 |
01/27/2017 |
ASAHI PTCA Guide Wire ASAHI SUOH 03 |
ASAHI INTECC CO., LTD. |
YASUYUKI KAWAHARA |
| K162336 |
01/12/2017 |
Contour Next EZ Blood Glucose Monitoring System |
Ascensia Diabetes Care US Inc. |
Jennifer L. Gregory |
| K163004 |
01/30/2017 |
Radifocus Glidewire Advantage Track |
Ashitaka Factory of Terumo Coporation |
Dina Justice |
| K171482 |
11/16/2017 |
NEPHROCHECK Test System |
Astute Medical, Inc. |
Karin Hughes |
| K163408 |
01/03/2017 |
Isolator Multifunctional Linear Pen |
AtriCure Inc. |
Melissa Smallwood |
| K163231 |
01/17/2017 |
Chameleon PTA Balloon Catheter |
AV Medical Technologies Ltd |
Limor Sandach |
| K170595 |
11/07/2017 |
IV Administration Sets |
B. Braun Medical Inc. |
Nancy Skocypec |
| K170897 |
11/03/2017 |
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site |
B. Braun Medical Inc. |
Angela J. Caravella |
| K162034 |
01/30/2017 |
OBS Electrosurgical Generator (Model: OBS-350A) |
Baisheng Medical Co.,Ltd. |
Peter Mao |
| K161231 |
01/23/2017 |
FacilisÖ Spinal System |
BAUI BIOTECH CO., LTD. |
BETTY YEN |
| K173089 |
11/27/2017 |
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K173365 |
11/17/2017 |
Bausch + Lomb Boston Scleral Lens Case |
Bausch & Lomb Incorporated |
Nancy Fehrman |
| K162887 |
01/06/2017 |
PrismaSATE |
Baxter Healthcare Corporation |
Kristen Bozzelli |
| K161949 |
01/31/2017 |
OsteoCool V-3 RF Ablation System |
Baylis Medical Company Inc. |
Meghal Khakhar |
| K162208 |
01/09/2017 |
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent |
BECKMAN COULTER INC. |
Geraldine Fuentespina |
| K161508 |
01/09/2017 |
Ceruloplasmin |
BECKMAN COULTER IRELAND INC. |
MARGUERITA SWEENEY |
| K170524 |
11/13/2017 |
Access AMH |
Beckman Coulter, Inc. |
Debbie Kidder |
| K163429 |
01/04/2017 |
B6 |
Beijing East Whale Imaging Technology Co., Ltd |
Sharon Fan |
| K171026 |
11/01/2017 |
Mytens Model: BW-TSX |
Bewell Connect Corp. |
Jacob Chen |
| K163015 |
01/10/2017 |
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak |
BIO-RAD LABORATORIES |
ELIZABETH PLATT |
| DEN170017 |
11/24/2017 |
FilmArray Respiratory Panel 2 plus (RP2plus) |
BioFire Diagnostics, LLC |
Kristen J. Kanack |
| K172576 |
11/22/2017 |
BioHorizons Tapered Short Implants |
BioHorizons Implant Systems, Inc. |
Michael Davis |
| K163128 |
01/11/2017 |
Epic Pro |
Biolase, Inc |
Alicia Mszyca |
| K172771 |
11/29/2017 |
Epic Pro 940 |
Biolase, Inc |
Alicia Mszyca |
| K163042 |
01/27/2017 |
chromID Strepto B agar |
bioMerieux, Inc. |
Karen Russell |
| K163006 |
01/24/2017 |
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) |
bioMerieux, Inc. |
Jennifer Jines |
| K161217 |
01/12/2017 |
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) |
bioMerieux, Inc. |
Karen Russell |
| K161273 |
01/25/2017 |
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis |
Biomet, Inc. |
Carmen Albany |
| K162407 |
01/27/2017 |
L300 Go System |
BIONESS INC. |
MERCEDES BAYANI |
| K161255 |
01/19/2017 |
meso-relle (AAL34, AAL36, AM30G) |
BIOTEKNE SRL |
Fabio Tassi |
| K163660 |
01/26/2017 |
Pantera LEO |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K173372 |
11/24/2017 |
ExactechGPS Total Shoulder Application |
Blue Ortho |
Anthony Boyer |
| K161971 |
01/09/2017 |
Bindex BI-2 |
BONE INDEX FINLAND, LTD. |
Janne Karjalainen |
| K163058 |
01/30/2017 |
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle |
BOSTON SCIENTIFIC |
Jennifer Edouard |
| K172060 |
11/03/2017 |
Capio SLIM Suture Capturing Device |
Boston Scientific Corporation |
Rachel Nankervis |
| K172591 |
11/03/2017 |
Fixed Patient Leads ECG Cable (Model 3153) |
Boston Scientific Corporation |
Elizabeth A. Lisowski |
| K173284 |
11/16/2017 |
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) |
Boston Scientific Corporation |
Mugdha Dongre |
| K172453 |
11/09/2017 |
WATCHDOG Hemostasis Valve Kit |
Boston Scientific Corporation |
Lori Berends |
| K162146 |
01/05/2017 |
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) |
BRIGHTWAY HOLDINGS SDN BHD. |
G. BASKARAN |
| K163176 |
01/12/2017 |
Exilis XP II |
BTL Industries, Inc. |
David Chmel |
| K161202 |
01/05/2017 |
C2 Cryoballoon Ablation System |
C2 THERAPEUTICS, INC. |
Theresa Brandner-Allen |
| K162201 |
01/11/2017 |
Desara TV, Desara Blue TV |
CALDERA MEDICAL, INC. |
Vicki Gail |
| K161967 |
01/27/2017 |
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm |
Callisyn Biomedical, Inc. |
Shallwei Sun |
| K162121 |
01/18/2017 |
Siconus SI Joint Fixation System |
CAMBER SPINE TECHNOLOGIES |
DAMIAN HEINZ |
| K172446 |
11/07/2017 |
SPIRA-C Open Matrix Cervical Interbody |
Camber Spine Technologies |
Michael Black |
| K161328 |
01/13/2017 |
Cantab Mobile |
CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD. |
Nancy D. Clementi |
| K171270 |
11/17/2017 |
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS |
Canon, Inc |
SHINJI MORI |
| K162909 |
01/27/2017 |
CSX-30 Flat Panel Detector |
Canon, Inc. û Medical Equipment Group |
Shinji Mori |
| K163170 |
01/31/2017 |
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 |
CAPILLUS, LLC |
PATRICIA SCHNOOR |
| K162181 |
01/06/2017 |
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set |
CARDIACASSIST INC. |
GREG JOHNSON |
| K161418 |
01/19/2017 |
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set |
CARDINAL HEALTH |
Judith Harbour |
| K170405 |
11/02/2017 |
BD Curve Ascites Shunt |
CareFusion |
Tamara Brey |
| K162432 |
01/18/2017 |
Multi-Link X2 ECG Cable and Lead Wire System |
CAREFUSION 2200 INC. |
ERIKA FERNANDEZ |
| K172609 |
11/03/2017 |
CSMC Cardiac Suite |
Cedars-Sinai Medical Center |
Geoff Pollard |
| K173006 |
11/28/2017 |
Cefaly Dual |
CEFALY Technology |
Jean-Yves Mignolet |
| K163519 |
01/13/2017 |
RX DC |
CEFLA SC |
BORTOLOTTI LORENZO |
| K170102 |
11/13/2017 |
Pekkton Ivory |
CENDRES+METAUX SA |
Uli DIERMANN |
| K172525 |
11/13/2017 |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Central Medicare Sdn. Bhd. |
Arivalagan Subramaniam |
| K172642 |
11/28/2017 |
Orange Non Sterile Powder Free Nitrile Examination Gloves |
Central Medicare Sdn. Bhd. |
Arivalagan Subramaniam |
| K160589 |
01/19/2017 |
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe |
CERTA DOSE, INC. |
SARAH HANSSEN |
| K172538 |
11/30/2017 |
Disposable Linear Stapler, Disposable Linear Cutter |
Changzhou Kangdi Medical Stapler Co.,Ltd. |
Eve Zhou |
| K170983 |
11/22/2017 |
NIOX VERO |
Circassia AB |
Susanne Parks |
| K172083 |
11/08/2017 |
IdysÖ ALIF System |
CLARIANCE SAS |
Pascal Rokegem |
| K173192 |
11/08/2017 |
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit |
Codman & Shurtleff, Inc |
Megan Palumbo |
| K162563 |
01/05/2017 |
YOGA Microcatheter |
CODMAN & SHURTLEFF, INC. |
YOON HEE BEATTY |
| K170422 |
11/02/2017 |
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS |
Coloplast Corp |
Cori Ragan |
| K170362 |
11/15/2017 |
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS |
Coloplast Corp |
Cori Ragan |
| K162057 |
01/11/2017 |
ConceptoMed Luer-Jack Slip 10ml |
ConceptoMed AS |
Marit Martinsen |
| K163258 |
01/25/2017 |
CrossFT Knotless Suture Anchor with Disposable Driver |
ConMed Corporation |
Nyrobia Freeman |
| K170856 |
11/17/2017 |
CMS600P2 B-Ultrasound Diagnostic System |
Contec Medical Systems Co., LTD. |
Xueyong Li |
| K172924 |
11/21/2017 |
GentleCath Intermittent Urinary Catheter |
ConvaTec Limited |
Hannah Sharp |
| K161762 |
01/13/2017 |
DynaMatrix/Dynamatrix Plus |
COOK BIOTECH INCORPORATED |
Perry W. Guinn |
| K173289 |
11/15/2017 |
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter |
Cook Incorporated |
David E. Chadwick |
| K161504 |
01/06/2017 |
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray |
COOK INCORPORATED |
Steven Lawrie |
| K170931 |
11/13/2017 |
CXI TriForce Peripheral Crossing Set |
Cook Incorporated |
Sarah Reeves |
| K172278 |
11/22/2017 |
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent |
Cook Incorporated |
Samuel Engelman |
| K173355 |
11/17/2017 |
Gastric Sizing Balloon Catheter |
Cook Incorporated |
Colin Jacobs |
| K173009 |
11/07/2017 |
NCompass Nitinol Stone Extractors |
Cook Incorporated |
Colin Jacob |
| K173068 |
11/17/2017 |
Performer Introducer |
COOK Incorporated |
Reuben G. Lidster |
| K161236 |
01/27/2017 |
Universa Firm Ureteral Stents and Stent Sets |
COOK INCORPORATED |
JAMIE RIDNER |
| K161641 |
01/05/2017 |
LOSPA IS ACP System |
CORENTEC CO., LTD |
J.S. DANIEL |
| K163620 |
01/19/2017 |
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves |
Covidien |
Nicole Genco |
| K162802 |
01/24/2017 |
Barrx Anorectal RFA Wand |
COVIDIEN LLC |
RACHEL SILVA |
| K172757 |
11/02/2017 |
Valleylab FX8 Electrosurgical Platform |
Covidien llc |
Sharon McDermott |
| K162253 |
01/06/2017 |
Trapper Exchange Device |
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL |
ORLA HICKEY |
| K172128 |
11/22/2017 |
EsoFLIP« ES-310 Balloon Catheter |
Crospon Ltd. |
John OÆDea |
| K162064 |
01/05/2017 |
CrossBay IVF Embryo Transfer Catheter Set |
CrossBay Medical Inc. |
Piush Vidyarthi |
| K172769 |
11/30/2017 |
CryOmega Flexx |
CryoConcepts LP |
R Sam Niedbala |
| K160178 |
01/11/2017 |
Lympha-Flow(LF1200) |
DaeSung Maref Co., Ltd |
Jae-wha Lee |
| K171473 |
11/07/2017 |
CompressynÖ Staple |
Dallen Medical, Inc. |
Al Memmolo |
| K163542 |
01/31/2017 |
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case |
Datascope Corp. |
Helder A. Sousa |
| K172045 |
11/03/2017 |
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 |
Datex-Ohmeda, Inc. |
Trishia Mercier |
| K173018 |
11/20/2017 |
MDR17 Mobile Direct Radiographic System |
Del Medical, Inc. |
Tony Bavuso |
| K162397 |
01/19/2017 |
Titan 3 Low Speed Angle Attachments |
DENTALEZ, INC |
Dan Laskowitz |
| K161281 |
01/11/2017 |
Dentalis Bio Solution Implants |
DENTALIS BIO SOLUTION IMPLANTS LLC |
Osnat Yanai |
| K172398 |
11/22/2017 |
DENTCA DENTURE Teeth |
DENTCA, INC. |
Jason Lee |
| K171694 |
11/29/2017 |
s-Clean TiN Coating Abutments |
Dentis Co., Ltd. |
Sun Chul Shin |
| K160965 |
01/13/2017 |
SuperLine |
DENTIUM CO., LTD. |
YOUNJUNG YUK |
| K163605 |
01/19/2017 |
LEDEX WL070+ |
DENTMATE TECHNOLOGY CO., LTD. |
CHENG-FENG CHOU |
| K172225 |
11/30/2017 |
Atlantis Abutment for MIS Implant |
Dentsply Sirona |
Karl Nittinger |
| K172030 |
11/27/2017 |
Devon 51 |
Devon Medical Products (Jiangsu) Ltd. |
Julian Chu |
| K162969 |
01/06/2017 |
LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set |
DiaSorin Inc. |
John Walter |
| K162959 |
01/04/2017 |
LIAISON« EA IgG and LIAISON« EA IgG Serum Control Set |
DIASORIN INC. |
JOHN WALTER |
| K162961 |
01/05/2017 |
LIAISON« VCA IgG and LIAISON« VCA IgG Serum Control Set; LIAISON« EBNA IgG and LIAISON« EBNA IgG Serum Control Set |
DIASORIN INC. |
JOHN WALTER |
| K170959 |
11/24/2017 |
DIXI Medical Microdeep Depth Electrode |
DIXI Medical |
Lucie Petegnief |
| K171004 |
11/07/2017 |
Hintermann Series H2 Total Ankle System |
Dt MedTech LLC |
Shawn T Huxel |
| K172007 |
11/22/2017 |
CamX Triton HD Proxi Head |
Duerr Dental AG |
Oliver Lange |
| K160591 |
01/23/2017 |
D.O.R.C. Disposable Cryo Probe |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
DANIELLE SLEEGERS |
| DEN170041 |
11/29/2017 |
GeneSTAT.MDx Coccidioides Assay |
DxNA, LLC |
Ernie Sumsion |
| K162285 |
01/27/2017 |
EBM iDO Viewer 1.2.1 |
EBM Technologies Incorporated |
John Su |
| K173034 |
11/14/2017 |
FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) |
Echosens |
Karine Bonenfant |
| K162088 |
01/27/2017 |
Ecomed Disposable Angiographic Syringes |
ECOMED SOLUTIONS, LLC |
DAVID YUREK |
| K162055 |
01/31/2017 |
Acclarix LX8 Diagnostic Ultrasound System |
EDAN INSTRUMENTS INC |
Alice Yang |
| K173003 |
11/15/2017 |
U50 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Alice Yang |
| K163693 |
01/26/2017 |
IntraClude Intra-Aortic Occlusion Device |
Edwards Lifesciences LLC |
Lisa G. Hessabi |
| K172660 |
11/17/2017 |
Duravess bovine pericardial vascular patch |
Edwards Lifesciences, LLC |
Christine Chun |
| K172738 |
11/08/2017 |
RadiForce RX560, RX560-AR |
EIZO Corporation |
Hiroaki Hashimoto |
| K172362 |
11/17/2017 |
DEKA SMARTXIDE TOUCH |
EL.EN Electronic Engineering Spa |
Paolo Peruzzi |
| K172363 |
11/17/2017 |
DEKA SMARTXIDE ULTRASPEED |
EL.EN. Electronic Engineering Spa |
Paolo Peruzzi |
| K162490 |
01/06/2017 |
Disc-FX System |
ELLIQUENCE LLC |
Paul D. Buhrke IV |
| K172703 |
11/13/2017 |
Disposable Snap Electrode |
Embla Systems |
Sanjay Mehta |
| K171534 |
11/08/2017 |
SurgicalPreview |
Endo Vantage, LLC |
Robert S. Green |
| K162197 |
01/18/2017 |
EndoClot |
EndoClot Plus Co., Ltd. |
Hendry Zhang |
| K163541 |
01/13/2017 |
Magseed Magnetic Marker System |
ENDOMAGNETICS LTD |
ANDREW SHAWCROSS |
| K173399 |
11/30/2017 |
Endophys Pressure Sensing Sheath Kit- 8F |
Endophys Holdings, LLC |
Phillip Purdy |
| K172441 |
11/06/2017 |
EPIC Extremity Fracture Plate System |
EPIC Extremity, LLC |
Dan Schwartzbauer |
| K163454 |
01/05/2017 |
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm |
ETHICON ENDO-SURGERY, LLC |
Carmen Ortiz |
| K172580 |
11/20/2017 |
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, |
Ethicon Endo-Surgery, LLC |
Carmen Ortiz |
| K170767 |
11/01/2017 |
Surgical Stainless Steel Suture, Stainless Steel Suture |
Ethicon, Inc. |
Hrishikesh Khatav |
| K163533 |
01/12/2017 |
EzDent-i; E2; ProraView |
EWOO SOFT CO., LTD. |
YOUNG SEOK KIM |
| K172260 |
11/06/2017 |
Omni Foot Plating System |
Extremity Medical, LLC. |
Brian Smekal |
| K162767 |
01/09/2017 |
Sentinel BreastScan II System |
First Sense Medical, LLC |
Alan Alan Klevens |
| K161412 |
01/18/2017 |
F&P BrevidaÖ Nasal Pillows Mask |
Fisher & Paykel Healthcare Ltd. |
Amelia Ortiz |
| K161686 |
01/24/2017 |
F&P InfoSmart |
FISHER & PAYKEL HEALTHCARE LTD. |
Jayanti Karandikar |
| K171467 |
11/09/2017 |
BioZorb Marker GOLD / LP Marker GOLD |
Focal Therapeutics |
George Hermann |
| K163521 |
01/12/2017 |
Lumipulse G LH Calibrators |
FUJIREBIO DIAGNOSTICS, INC |
DIANA DICKSON |
| K163534 |
01/13/2017 |
Lumipulse G FSH-N Calibrators |
Fujirebio Diagnostics, Inc. |
Diana Dickerson |
| K163546 |
01/13/2017 |
Lumipulse G Progesterone-N Calibrators |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K163544 |
01/12/2017 |
Lumipulse G Prolactin |
FUJIREBIO DIAGNOSTICS, INC. |
STACEY DOLAN |
| K162455 |
01/17/2017 |
Humelock Reversed Shoulder |
FX SOLUTIONS |
Jean-Jacques Martin |
| K173037 |
11/21/2017 |
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel |
Galil Medical Inc. |
Lynne Davies |
| K163205 |
01/12/2017 |
48CH Head Coil |
GE Healthcare Coils (USA Instruments, Inc.) |
Mary A. Mayka |
| K172695 |
11/22/2017 |
AIR Anterior Array, AIR Posterior Array |
GE Healthcare Coils (USA Instruments, Inc.) |
Mary A. Mayka |
| K172700 |
11/09/2017 |
OEC One |
GE HUALUN MEDICAL SYSTEMS CO., LTD. |
Lifeng Wang |
| K173341 |
11/02/2017 |
Vivid E80, Vivid E90, Vivid E95 |
GE Medical Systems |
Tracey Ortiz |
| K171580 |
11/01/2017 |
Monitor B125, Monitor B105 |
GE MEDICAL SYSTEMS (CHINA) CO., LTD. |
Sun YanLi |
| K172550 |
11/16/2017 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Rachel Schandel |
| K163281 |
01/26/2017 |
FastStroke |
GEf Medical Systems SCS |
Kristine Schraufnagel |
| K171050 |
11/09/2017 |
Geistlich Fibro-Gide |
Geistlich Pharma AG |
Marco Steiner |
| K171842 |
11/03/2017 |
Geistlich Wound Matrix |
Geistlich Pharma AG |
Jan van der Ploeg |
| K171736 |
11/15/2017 |
Geri Embryo Incubator and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K172569 |
11/22/2017 |
GenePOC CDiff |
GenePOC Inc. |
Guy Sevigny |
| K172469 |
11/30/2017 |
TiLock Modular Spinal System |
Genesys Spine |
Brian J. Bergeron |
| K170606 |
11/16/2017 |
Acrylic Herbst Appliance with Micro-Recorder |
Gergen's Orthodontic Lab |
Chris Morrison |
| K173166 |
11/13/2017 |
ANTHEM Fracture System |
Globus Medical Inc. |
Kelly J. Baker |
| K162315 |
11/09/2017 |
FORTIFY Corpectomy Spacers |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K162618 |
01/23/2017 |
CONCORD Plus Radiopaque Bone Cement |
GLOBUS MEDICAL, INC. |
KELLY J. BAKER |
| K160469 |
01/05/2017 |
AGNES |
GOWOONSESANG COSMETICS CO., LTD |
Kyeong Tai Ko |
| K162179 |
01/10/2017 |
osteo-WEDGE II « Open Wedge Bone Locking Plate System |
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA |
Angela Recchia |
| K161904 |
01/18/2017 |
GEO Bone Screw System |
GRAMERCY EXTREMITY ORTHOPEIDICS, LLC |
MICHAEL P. SIMPSON |
| K163113 |
01/19/2017 |
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K172712 |
11/06/2017 |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
GRI Medical & Electronic Technology Co, Ltd |
Marty D. Paugh |
| K162234 |
01/04/2017 |
Truscope Ultra Patient Monitor |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Jing Liang |
| K170229 |
11/08/2017 |
Dental High-speed Turbine Handpiece |
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. |
KRISTI YANG |
| K170236 |
11/21/2017 |
Dental Low-speed Turbine Handpiece |
Guangdong JINME Medical Technology Co., Ltd. |
Kristi Yang |
| K162423 |
01/03/2017 |
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System |
HAEMONETICS CORPORATION |
MARK ANZALONE |
| K172442 |
11/06/2017 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) |
Hartalega NGC SDN. BHD. |
Kuan Mun Leong |
| K162924 |
01/24/2017 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| K162819 |
01/09/2017 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K162818 |
01/09/2017 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K162381 |
01/31/2017 |
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs |
HEALTHY GLOVE CO., LTD |
Teoh Choh Shee |
| K172649 |
11/01/2017 |
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor |
Heidelberg Engineering GmbH |
Gerhard Zinser |
| K170664 |
11/09/2017 |
Odyssey Micro Catheter |
Heraeus Medical Components, LLC |
Margaret Batchelder |
| K171681 |
11/21/2017 |
Hermes Medical Imaging Suite v5.7 |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K171719 |
11/21/2017 |
Hybrid3D |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K162390 |
01/30/2017 |
ET Hybrid Abutment |
HIOSSEN INC. |
David Kim |
| K171803 |
11/29/2017 |
HIVOX OTC Electrical Stimulator |
Hivox Biotek Inc. |
Linda Lin |
| K163179 |
01/26/2017 |
Onli Intermittent Catheter |
HOLLISTER INCORPORATED |
JEANNE LEE |
| K170353 |
11/01/2017 |
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT |
HORIBA ABX SAS |
Caroline Ferrer |
| K161036 |
01/06/2017 |
Hospira Extension Set, Hospira Primary Set |
HOSPIRA, INC. |
CHARLES NEITZEL |
| K172634 |
11/16/2017 |
Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Shahrir Alam |
| K173099 |
11/30/2017 |
Fortis and Hana Anterior Cervical Plate System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K172491 |
11/29/2017 |
ICONN Square 2.5MM Suture Anchor |
ICONN Orthopedics, LLC |
Whitt Israel |
| K161593 |
01/19/2017 |
GMI Frontier Dental Implant System |
ILERIMPLANT S.L. |
ANTONIO COSO |
| K173273 |
11/09/2017 |
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| K161158 |
01/31/2017 |
IDS-iSYS Intact PTHN |
IMMUNODIAGNOSTIC SYSTEMS LTD |
CHRIS PRICE |
| K163554 |
01/17/2017 |
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test |
Immunostics, Inc. |
Antoinette Prusik |
| K162764 |
01/19/2017 |
JAZZ FRAME SYSTEM |
IMPLANET S.A. |
REGIS LE COUEDIC |
| K173121 |
11/28/2017 |
Ankle Fusion Plating System |
In2Bones SAS |
Morgane Grenier |
| K170688 |
11/28/2017 |
PITÆStop« implant |
In2Bones SAS |
Morgane Grenier |
| K172300 |
11/27/2017 |
CoLink View Plating System |
In2Bones USA, LLC |
Rebecca Wahl |
| DEN170018 |
11/15/2017 |
NSS-2 System |
Innovative Health Solutions (IHS), Inc. |
Tom Carrico |
| K171788 |
11/03/2017 |
Reprocessed Halo XP Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K173410 |
11/14/2017 |
n!ce for Planmill |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K172903 |
11/22/2017 |
HemosIL D-Dimer HS 500 |
Instrumentation Laboratory Co. |
Shajunath Nirupama |
| K163456 |
01/06/2017 |
DuraGen Secure Dural Regeneration Matrix |
INTEGRA LIFESCIENCES CORPORATION |
YARA HAMID |
| K163457 |
01/06/2017 |
NeuraGen 3D Nerve Guide Matrix |
Integra LifeSciences Corporation |
Gabriella Green |
| K162851 |
01/24/2017 |
eLyx-PRO |
Intelligent Sensory Concept SA |
Joel Chanteraud |
| K172849 |
11/16/2017 |
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray |
Intellijoint Surgical Inc. |
Brandon Gingrich |
| K170900 |
11/09/2017 |
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories |
INTERVENE Group Ltd |
Homer Trieu |
| K170662 |
11/22/2017 |
Non Contact Infrared Forehead Thermometer |
Intrinity Global Limited |
Alex Kwok |
| K161178 |
01/19/2017 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K162817 |
01/18/2017 |
Noddle(TM) |
IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC. |
R. RIVES BIRD |
| K163223 |
11/02/2017 |
ORCA (tm) - Operational Rescue Containment Apparatus |
ISOVAC PRODUCTS, LLC |
PETER M. JENKNER |
| K163087 |
11/02/2017 |
PixoTest Blood Glucose Monitoring System |
iXensor Company Ltd. |
JAMIE WU |
| K170080 |
11/02/2017 |
Neodent Implant System - CM Pro PEEK Abutment |
JJGC Industria e Comercio de Materiais Dentarios SA |
Julianne Lechechem |
| K173329 |
11/15/2017 |
jFit Surgical Planner |
JointVue LLC |
Mohamed R. Mahfouz |
| K170666 |
11/22/2017 |
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K162427 |
01/27/2017 |
Vado Bi-Directional Steerable Sheath |
KALILA MEDICAL, INC. |
CARRIE NEUBERGER |
| K163479 |
01/11/2017 |
R2P Metacross RX |
KANEKA CORPORATION |
TOSHIHIKO MOTOMINE |
| K162882 |
01/26/2017 |
KARL STORZ ICG Imaging System |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE S. CHEN |
| K162790 |
01/26/2017 |
V.A.C.ULTA Negative Pressure Wound Therapy System |
KCI USA, Inc. (Kinetic Concepts, Inc.) |
Margaret Marsh |
| K162164 |
01/13/2017 |
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord |
KERR CORPORATION |
MOHAMMAD SAAD ANSARI |
| K161923 |
11/09/2017 |
J2A SLA Dental Implant System |
KJ Meditech Co., Ltd. |
Goong-san Nam |
| K163579 |
11/21/2017 |
KLS Martin Individual Patient Solutions |
KLS Martin LP |
Jennifer Damato |
| K153128 |
01/13/2017 |
Kolplast Cervical Sample Collection Kit |
KOLPLAST CI SA |
DANIELA FERACIN |
| K172639 |
11/03/2017 |
PALLAS 308/311 Solid-State UV Laser System |
Laseroptek Co.Ltd |
Hong Chu |
| K162511 |
01/13/2017 |
LELO RESPECT HEX Natural Rubber Latex Condom |
LELO INC. |
PAVLE SEDIC |
| K171589 |
11/17/2017 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Donna Gasper |
| K170799 |
11/14/2017 |
AP 50/30 Insufflator with Insuflow Port |
LEXION Medical LLC |
Bernard Horwath |
| K162098 |
01/30/2017 |
LED Phototherapy Device |
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION |
Barry Yuan |
| K171136 |
11/20/2017 |
LIA Pregnancy Test |
LIA Diagnostics |
Anna Couturier |
| K162323 |
01/12/2017 |
Tooth Shade Resin Material |
LIAONING UPCERA CO.,LTD |
Charles Shen |
| K170473 |
11/08/2017 |
C2 femoral stem |
Limacorporate S.p.A. |
Antonio Soleti |
| K151857 |
01/09/2017 |
Love Alchemy's Love Lotion |
LOVE ALCHEMY LLC |
Eric Weiss |
| K173171 |
11/24/2017 |
FilmArray RP2/RP2plus Control Panel |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| K162705 |
01/05/2017 |
VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit |
MAINE STANDARDS COMPANY LLC |
JAMES CHAMPLIN |
| K172301 |
11/02/2017 |
Mako Partial Knee Application |
MAKO Surgical Corp. |
Andrea Dwyer Steiner |
| K171571 |
11/30/2017 |
NexSite HD, Hemodialysis Step Tip Catheter (60cm) |
Marvao Medical Devices, Ltd. |
Christopher Davey |
| K171121 |
11/17/2017 |
Masimo Root Monitoring System and Accessories |
Masimo Corporation |
Marguerite Thomlinson |
| K163643 |
11/16/2017 |
SIRIO H3 |
MASMEC SPA |
Domenico Marino |
| K172054 |
11/03/2017 |
Materialise Glenoid Positioning System |
Materialise NV |
Oliver Clemens |
| K172650 |
11/20/2017 |
Materialise PKA Guide System |
Materialise NV |
Oliver Clemens |
| K163156 |
01/18/2017 |
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides |
Materialise NV |
Oliver Clemens |
| K170513 |
11/01/2017 |
MAUSER PG II Sharps Container |
Mauzer USA LLC |
Tatiana Smoleeva |
| K161219 |
01/26/2017 |
Zmaxx T Series |
Maxx Digm, Inc. |
Keith Jew |
| K171131 |
11/08/2017 |
MHC Standard and NRFit Tip Syringes |
Mazza Healthcare, LLC. |
Michael A. Mazza |
| K171610 |
11/16/2017 |
MC3 QuickFlow Dual Lumen Catheter |
MC3 Incorporated |
Martha Rumford |
| K172347 |
11/01/2017 |
GMK Hinge, GMK Revision |
Medacta International SA |
Stefano Baj |
| K170690 |
11/29/2017 |
M-Vizion Femoral Revision System |
Medacta International SA |
Stefano Baj |
| K162084 |
01/03/2017 |
MOTO Partial Knee System |
Medacta International SA |
Stefano Baj |
| K172344 |
11/13/2017 |
Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) |
MEDAX S.R.L. UNIPERSONALE |
Stefano Cavalieri |
| K171618 |
11/16/2017 |
Symetrex Long Term Hemodialysis Catheter |
Medcomp (DBA Medical Components, Inc.) |
Courtney Nix |
| K162786 |
01/25/2017 |
PASS LP Spinal System |
MEDICREA INTERNATIONAL S.A |
DAVID RYAN |
| K163595 |
11/13/2017 |
IMPIX 3D Print Cages |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| K160536 |
01/05/2017 |
Chaorum Implant System |
MEDIMECCA CO., LTD. |
PARK YOUNG WAN |
| K162434 |
01/19/2017 |
NC Gallant PTCA Catheter |
MEDINOL LTD. |
MICHAL HERSHKOVITZ |
| K160471 |
01/31/2017 |
Medline Non-Surgical Isolation Gown- |
MEDLINE INDUSTRIES, INC. |
PAULINE MARALIT |
| K160660 |
01/19/2017 |
Medline Waste Station |
Medline Industries, Inc. |
Matt Clausen |
| K171114 |
11/27/2017 |
HEALIX ADVANCE KNOTLESS Anchor |
Medos International SARL |
Julie Vafides |
| K171376 |
11/02/2017 |
DynaNail TTC Fusion System |
MedShape, Inc. |
Courtney Kline |
| K172373 |
11/02/2017 |
Compound W Nitro-Freeze |
Medtech Products Inc. |
Jean Boyko |
| K161274 |
01/18/2017 |
Bondiloxs Topical Hemostatic Granules |
MEDTRADE PRODUCTS LTD. |
Andrew Whitton |
| K172328 |
11/02/2017 |
SOVEREIGNÖ Spinal System |
Medtronic Sofamor Danek USA, INC |
Kanesha Hines |
| K172984 |
11/20/2017 |
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and |
Medtronic, Inc. |
Lisa Stone |
| K170341 |
11/02/2017 |
Medussa-PL Cage |
Medyssey USA, Inc. |
Shawn Kim |
| K161637 |
01/05/2017 |
Poseidon OCT Spinal Fixation System |
Medyssey USA, Inc. |
Shawn Kim |
| K172277 |
11/03/2017 |
Phlebo Press DVT Model |
Mego Afek AC Ltd. |
Reuven Yunger |
| K163280 |
01/27/2017 |
RP Lite 760R |
Mego Afek AC Ltd. |
Ilan Sharon |
| DEN170058 |
11/15/2017 |
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay |
Memorial Sloan-Kettering Cancer Center |
Christine England |
| K173136 |
11/16/2017 |
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses |
Menicon Co., Ltd. |
Kenichi Tanaka |
| K172936 |
11/30/2017 |
DestikneeÖ Total Knee System |
Meril Healthcare Pvt. Ltd. |
Bhavik Gondaliya |
| K172637 |
11/30/2017 |
HeRO Graft |
Merit Medical Systems, Inc. |
Susan Christensen |
| K162988 |
01/25/2017 |
PreludeSYNC Radial Compression Device |
Merit Medical Systems, Inc. |
Ileana Davis |
| K170517 |
11/16/2017 |
Merits Model R106/R136 Rehab Wheelchair |
Merits Healthcare Industries (suzhou) Co., LTD. |
Guangyong Li |
| K172689 |
11/29/2017 |
DESCRIBE PFD Patch |
Merz North America, Inc. |
Misty DÆOttavio |
| K162704 |
01/03/2017 |
Axium Prime Detachable Coil System |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Joyce Zhong |
| K162226 |
01/25/2017 |
Reliant Multistage Dilatation Balloon Catheter |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K161463 |
01/06/2017 |
SureClip(TM) Repositionable Hemostasis Clip |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K170916 |
11/28/2017 |
Portable Nebulizer |
MicroBase Technology Corporation |
Molly Hsieh |
| K173183 |
11/22/2017 |
CEDIA Heroin Metabolite (6-AM) Assay |
Microgenics Corporation |
Minoti Patel |
| K173385 |
11/30/2017 |
Graft Delivery, DePuy Synthes |
Micromedics, Inc. (d/b/a Nordson MEDICAL) |
Kristi Brezinka |
| K172218 |
11/21/2017 |
MIM û Y90 Dosimetry |
MIM Software Inc. |
Lynn Hanigan |
| K161902 |
01/12/2017 |
Meridian M110 Fetal Monitoring System |
MINDCHILD MEDICAL |
JIM ROBERTSON |
| K161855 |
11/27/2017 |
LED Curing Light |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K173305 |
11/17/2017 |
NeuroBlate System |
Monteris Medical, |
David H. Mueller |
| K162651 |
01/18/2017 |
Breast BI 7 MR Coil Mammavention 3T |
MORAS MRI products GmbH |
Zahed Sedighiani |
| K161517 |
01/11/2017 |
Mortara Surveyor Patient Monitor |
MORTARA INSTRUMENT, INC. |
SARAH WEBER |
| K172620 |
11/08/2017 |
SyndesMetrics Syndesmosis Repair System |
Mortise Medical LLC |
Robert Hoy |
| K173290 |
11/28/2017 |
DuoFLEX Coil Suite |
MR Instruments, Inc |
Leon Ricord |
| K161303 |
01/26/2017 |
dynaMXÖ Compression Plate |
MX ORTHOPEDICS, CORP. |
Howard L. Schrayer |
| K171155 |
11/21/2017 |
Surgical Angle Handpiece, Surgical Straight Handpiece |
Nakanishi Inc. |
Kimihiko Satoh |
| K163414 |
11/21/2017 |
Ultrasonic scaler |
NANNING VV DENTAL CO., LTD. |
Liang chaojun |
| K173423 |
11/17/2017 |
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled |
Nano4Imaging GmbH |
Christoph R. Manegold |
| K162754 |
01/12/2017 |
FREND Vitamin D Test System |
NanoEnTek USA, Inc. |
Jimmy Chen |
| K172711 |
11/03/2017 |
Comet-PLUS |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K161536 |
01/05/2017 |
EasyOne Air Spirometer |
NDD MEDIZINTECHNIK AG |
JERRY MASIELLO |
| K160991 |
01/10/2017 |
Neo GBR System |
NEOBIOTECH CO., LTD. |
In Ho Kim |
| K173377 |
11/28/2017 |
3.0T 16ch Breast Coil |
NeoCoil, LLC |
Michael Leigh |
| K171884 |
11/22/2017 |
I-Portal Portable Assessment System - Nystagmograph (I-PAS) |
Neuro Kinetics, Inc |
Brian Sullivan |
| K172539 |
11/22/2017 |
CereTom Elite |
NeuroLogica Corporation, a Subsidiary of Samsung Electronics |
Ninad Gujar |
| K161650 |
01/19/2017 |
Polysmith Sleep System, Model NTI7593 |
Neurotronics, Inc. |
David Pezet |
| K171902 |
11/10/2017 |
Nexstim Navigated Brain Therapy (NBT) System 2 |
Nexstim Plc |
Rainer Harjunpaa |
| K173044 |
11/20/2017 |
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
Ningbo Albert Novosino Co.,Ltd. |
Ningbo Albert Novosino |
| K163122 |
01/31/2017 |
NobelClinician, DTX Studio implant |
NOBEL BIOCARE AB |
CHALEMAGNE CHUA |
| K171466 |
11/29/2017 |
NobelDesign, DTX Studio Design |
Nobel Biocare AB |
Charlemagne Chua |
| K163324 |
01/27/2017 |
nordicBrainEx |
NordicNeurolab AS |
CHANDANA GURUNG BHANDARI |
| K163490 |
01/06/2017 |
StatStrip Xpress 2 Glucose Hospital Meter System |
Nova Biomedical Corporation |
Paul W. MacDonald |
| K170464 |
11/07/2017 |
StatStrip Xpress Blood Glucose Monitoring System |
Nova Biomedical Corporation |
Eliza Wang |
| K163310 |
01/18/2017 |
NovaBone IRM |
NovaBone Products, LLC |
Gregory Pomrink |
| K162885 |
01/11/2017 |
SPY Phi Open Field Handheld Fluorescence Imaging System |
NOVADAQ TECHNOLOGIES INC. |
JEN PENDLEBURY |
| K161688 |
01/27/2017 |
Advanced Gynecological Applicator |
NUCLETRON BV |
RUDOLF VOS |
| K173314 |
11/16/2017 |
LessRay System |
NuVasive, Incorporated |
Manthan J. Damani |
| K172497 |
11/24/2017 |
NuVasive AttraX Scaffold |
NuVasive, Incorporated |
Marysa E. Loustalot |
| K172979 |
11/06/2017 |
NuVasive« Growth Rod Conversion Set |
NuVasive, Incorporated |
Olga Lewis |
| K173030 |
11/21/2017 |
Vertera Spine Cohere Cervical Interbody Fusion Device |
NuVasive, Incorporated |
Michelle Cheung |
| K170074 |
01/24/2017 |
nvc |
Nvision Biomedical Technologies, LLC |
Diana L Langham |
| K162430 |
01/19/2017 |
UniStrip1 Generic Blood Glucose Test Strips |
OK BIOTECH CO., LTD. |
KE-MIN JEN |
| K163069 |
01/19/2017 |
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K171158 |
11/17/2017 |
Single Use Electrosurgical knife |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K170811 |
11/27/2017 |
Single Use Retrieval Nitinol Basket V |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172535 |
11/16/2017 |
Bipolar applicator CELON ProCurve V |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K163114 |
01/05/2017 |
Sapphire II PRO |
OrbusNeich Medical Inc. |
John Pazienza |
| K162962 |
01/23/2017 |
OrthAlign Plus System |
OrthAlign, Inc. |
David Vancelette |
| K172462 |
11/22/2017 |
OrthAlign Plus System |
OrthAlign, Inc. |
David Vancelette |
| K173247 |
11/08/2017 |
Surgical Planning Software version 1.1 |
Ortho Kinematics, Inc |
Adam Dietz |
| K172437 |
11/02/2017 |
CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K161466 |
01/24/2017 |
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
ORTHOFIX SRL |
Gianluca Ricadona |
| K173051 |
11/16/2017 |
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL |
Orthofix Srl |
Gianluca Ricadona |
| K161090 |
01/19/2017 |
Cranial PSI |
OSSDSIGN AB |
ULRIK BIRGERSSON |
| K170534 |
11/09/2017 |
PROLIXUS TOTAL KNEE SYSTEM |
OTIS Biotech Co., Ltd. |
Sanjay Lingot |
| K172925 |
11/30/2017 |
Contact Lens Case, Model: A-1, B-1 |
P L Overseas Limited |
Maggie Li |
| K162086 |
01/06/2017 |
MultiStim ECO |
PAJUNK GmbH Medizintechnologie |
Christian Quass |
| K161106 |
01/13/2017 |
PANPAC DISPOSABLE VACUUM CURETTES |
PANPAC MEDICAL CORPORATION |
YEN-MING PAN |
| K172176 |
11/21/2017 |
Parkell Universal Adhesive |
Parkell, Inc. |
David Mott |
| K172685 |
11/21/2017 |
LiverMultiScan |
Perspectum Diagnostics Ltd |
Jaco Jacobs |
| K163410 |
01/04/2017 |
DigitalDiagnost C50 |
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
ALINA ZHOU |
| K173187 |
11/16/2017 |
MobileDiagnost M50 |
Philips India Limited |
Nidhi Bathwal |
| K172226 |
11/09/2017 |
MX40 Release B.07 |
Philips Medical Systems |
Theresa Poole |
| K171850 |
11/09/2017 |
Philips CT Big Bore |
Philips Medical Systems (Cleveland) Inc. |
Michael Chilbert |
| K163210 |
01/31/2017 |
Philips CombiDiagnost R90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K162931 |
01/06/2017 |
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
Ruojuan Zhang |
| K163116 |
01/06/2017 |
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 |
Philips Medical Systems Nederland B.V. |
Ruojuan Zhang |
| K163715 |
01/26/2017 |
Allura Xper R9 |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
JEANETTE BECKER |
| K172822 |
11/22/2017 |
Azurion series R1.2 |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| K161767 |
01/27/2017 |
Philips IntelliVue GuardianSoftware |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Michael Asmalsky |
| K163120 |
01/10/2017 |
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Peng Cui |
| K171385 |
11/14/2017 |
Planmeca Romexis |
Planmeca Oy |
Lars Moring |
| K171868 |
11/11/2017 |
A1AT Genotyping Test |
Progenika Biopharma S.A., a Grifols Company |
Diego Tejedor |
| K172859 |
11/22/2017 |
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder |
Prosomnous Sleep Technologies |
David Kuhns |
| K172790 |
11/08/2017 |
ER-REBOA Catheter |
Prytime Medical Devices, Inc. |
Brian Young |
| K162946 |
01/06/2017 |
8ch Knee-Foot SPEEDER |
QUALITY ELECTRODYNAMICS, LLC |
KATHLEEN ARAS |
| K173446 |
11/17/2017 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K163013 |
01/06/2017 |
Quantib Brain 1.2 |
Quantib BV |
Rudolf Scholte |
| K171350 |
11/29/2017 |
Collision Check |
Radformation, Inc. |
Kurt Sysock |
| K162083 |
01/09/2017 |
RII Multi-function Infrared Thermometer, Model TH52Z |
Radiant Innovation Inc. |
Monica Chung |
| K162932 |
01/19/2017 |
Ranfac Fat Aspiration Cannula |
RANFAC CORP. |
CHRISTOPHER WHELAN |
| K173233 |
11/30/2017 |
ReliefBand 1.5 |
ReliefBand Technologies |
Dave Hartman |
| K162770 |
01/04/2017 |
Relign System |
Relign Corporation |
Nathan Nguyen |
| K171543 |
11/16/2017 |
Renovis Surgical Hip Replacement System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K161275 |
01/23/2017 |
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip |
RESEARCH INSTRUMENTS LIMITED |
Wendy Hassan |
| K161492 |
01/19/2017 |
Juno VPAP ST-A |
ResMed Ltd |
Jean-Nicolas Boudaud |
| K170853 |
11/02/2017 |
InnoSpire Go |
Respironics Respiratory Drug Delivery (UK) Ltd. |
Filippo Quadrelli |
| K161204 |
01/11/2017 |
ENDOCAM Flex HD Camera System 5521 |
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
MIKE LOITERMAN |
| K162173 |
01/12/2017 |
Elecsys CYFRA 21-1 CalCheck 5 |
Roche Diagnostics |
Adam Clark |
| K162895 |
01/18/2017 |
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 |
Roche Diagnostics |
Jane Phillips |
| K162606 |
01/23/2017 |
Elecsys TSH assay, cobas e 801 Immunoassay analyzer |
ROCHE DIAGNOSTICS |
ANGELO PEREIRA |
| K163694 |
11/07/2017 |
Rooti Rx ECG Event Recorder, Rooti Link APP Software |
Rooti Labs Ltd. |
Sue Chuang |
| K170868 |
11/30/2017 |
FIXIT Threaded Anchor System |
S.B.M SAS Science for Bio Materials |
Anne Cospin-Latapie |
| K170398 |
11/21/2017 |
S.I.N. Dental Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denis Oliveira |
| K172229 |
11/22/2017 |
GC85A |
Samsung Electronics Co.,Ltd. |
Jaesang NOH |
| K172514 |
11/17/2017 |
Trak Plus Male Fertility Testing System |
Sandstone Diagnostics, Inc. |
Ulrich Schaff |
| K172674 |
11/02/2017 |
Sapphire Cervical Implant System |
Sapphire Medical Group |
Anthony Ruggiero |
| K172292 |
11/24/2017 |
SALUS - Hygiene Instrument Reprocessing Container |
SciCan Ltd. |
Teresa Boyce |
| K172130 |
11/16/2017 |
Resorbable Mesh Device |
SeaSpine Orthopedics Corporation |
Jenny Fam |
| K173112 |
11/21/2017 |
LAP-iX |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K173111 |
11/28/2017 |
LAP-iX Suction Irrigation |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K172761 |
11/17/2017 |
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) |
Shanghai New Century Dental Materials Co., Ltd. |
Charles Shen |
| K173169 |
11/20/2017 |
Rapid Family |
SharpLight Technologies Ltd. |
Ilan Sharon |
| K172678 |
11/24/2017 |
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE |
Shen Wei USA Inc. |
Cheryl Reep |
| K171578 |
11/30/2017 |
Infrared thermometer |
Shenzhen Aeon Technology Co.,Ltd. |
Applicant Wendy |
| K153184 |
01/04/2017 |
Caremed Reusable & Disposable SPO2 Sensors |
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. |
XINLIN XIAO |
| K170965 |
11/03/2017 |
Fingertip Pulse Oximeter |
Shenzhen Jumper Medical Equipment Co., Ltd. |
Yang Gang |
| K171901 |
11/15/2017 |
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yanhong Bai |
| K162718 |
11/30/2017 |
Foot Drop System (Model XFT-2001D) |
SHENZHEN XFT Medical Limited |
JIANG XIAOYING |
| K162261 |
01/11/2017 |
CERAMAGE UP |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K171742 |
11/17/2017 |
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K162399 |
01/19/2017 |
Atellica CH Magnesium (Mg) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
LAURA J. DUGGAN |
| K173378 |
11/20/2017 |
syngo«.via protoNeo (Version VA20) |
Siemens Healthcare GmbH |
Abhineet Johri |
| K163252 |
01/10/2017 |
Mammomat Fusion with Stereotactic Biopsy |
SIEMENS MEDICAL SOLUTIONS USA, INC |
Denise Adams |
| K163396 |
01/04/2017 |
ACUSON P500 Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K172531 |
11/14/2017 |
Biograph mMR with mMR Angio Transfer Option |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K163312 |
01/27/2017 |
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K163211 |
01/27/2017 |
MAGNETOM Sempra with syngo MR E11S |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K173023 |
11/17/2017 |
Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K163421 |
01/03/2017 |
syngo.via MI Workflows |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K163635 |
01/12/2017 |
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems |
Siemens Medical Solutions USA, Inc. Ultrasound Group |
Sulgue Choi |
| K162483 |
01/09/2017 |
Symbia Intevo Bold |
SIEMENS MEDICAL SOLUTIONS, USA, INC. |
Cynthia Busch |
| K172020 |
11/29/2017 |
Arlington PLIF/TLIF Cage |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K172019 |
11/29/2017 |
Brisbane ALIF Device, Gladstone ALIF Device |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K162587 |
01/26/2017 |
ROCCIA« ACIF |
SILONY MEDICAL GMBH |
Bircan YILMAZ |
| K170946 |
11/24/2017 |
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant |
Skanray Technologies Private Limited |
Mahadevan J. |
| K162864 |
01/13/2017 |
OsteoVation Impact |
Skeletal Kinetics, LLC. |
Alicia Hemphill |
| K170071 |
11/09/2017 |
SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer |
Sleep Group Solutions |
Rani Ben-David |
| K171743 |
11/17/2017 |
Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves |
Smart Glove Corporation Sdn.Bhd |
Khon Pu Foo |
| K172451 |
11/17/2017 |
Dr.MUSIC 3s |
SmartMedicalDevice Co., Ltd. |
Dong-Min Lee |
| K171934 |
11/30/2017 |
Birmingham Hip (BH) Dual Mobility Insert |
Smith & Nephew, Inc. |
Mike Scott |
| K173331 |
11/16/2017 |
JOURNEY II XR Knee Instruments |
Smith & Nephew, Inc. |
Shereen Bienz |
| K162775 |
01/13/2017 |
Legion Cone System |
Smith & Nephew, Inc. |
Natalie Williams |
| K171073 |
11/21/2017 |
Smith & Nephew, Inc. REDAPT Augments |
Smith & Nephew, Inc. |
Kim Phan |
| K172458 |
11/09/2017 |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
Smiths Medical ASD, Inc. |
Mikael Evans |
| K170022 |
11/16/2017 |
Klockner Vega TiBase for CEREC |
SOADCO S.L. |
MARIA MITJANETA |
| K172622 |
11/21/2017 |
Microcyn Antimicrobial Skin and Wound Cleanser |
Sonoma Pharmaceuticals |
Brian W. Martin |
| K172851 |
11/15/2017 |
Microcyn Plus Antimicrobial Wound Care Solution |
Sonoma Pharmaceuticals, Inc. |
Brian Martin |
| K163427 |
01/03/2017 |
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K163634 |
11/06/2017 |
External Hex Implants |
SOUTHERN IMPLANTS (PTY) LTD |
LAURANDA BREYTENBACH |
| K162561 |
01/05/2017 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters |
SPECTRANETICS, INC. |
PRISCILA TAPIA |
| K172687 |
11/27/2017 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
Stephanie Byrum |
| K163657 |
01/18/2017 |
Quantum Workstation |
Spectrum Medical Ltd |
Mark Drain |
| K170235 |
11/29/2017 |
Lucent« |
Spinal Elements Inc. |
Julie Lamothe |
| K173175 |
11/01/2017 |
Paramount Anterior Cervical Cage System |
Spine Wave, Inc. |
Yvonne Riley-Poku |
| K162884 |
01/12/2017 |
SpineGuard DSG Zavation Screw System |
SPINEGUARD,S.A. |
Stephane Bette |
| K162879 |
01/30/2017 |
Elite Expandable Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K162694 |
01/12/2017 |
Ayers Rock Cervical interbody fusion system |
Spineway |
Nicolas Roth |
| K171492 |
11/20/2017 |
B7 2C Occlusion Balloon |
Spiration, Inc. |
Cheryl Frederick |
| K172223 |
11/17/2017 |
SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Samantha Schroeder |
| K162500 |
01/12/2017 |
Ostial Sprit Cannulae |
SPYDER MEDICAL |
MICHAEL WEBB |
| K173232 |
11/02/2017 |
myMerlin(TM) Mobile Application Model APP1001 |
St. Jude Medical |
Jennifer Dunham |
| K172472 |
11/17/2017 |
Micro-MEC 1.8% Glutaraldehyde Monitor Strip |
STERIS Corporation |
Jennifer Nalepka |
| K162631 |
01/27/2017 |
VERIFY STEAM Integrating Indicator - Short |
STERIS CORPORATION |
TRICIA CREGGER |
| K172644 |
11/03/2017 |
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base |
Stimwave Technologies Incorporated |
Elizabeth Greene |
| K171769 |
11/14/2017 |
Straumann PURE Ceramic Implants |
Straumann USA, LLC (on behalf of Institut Straumann AG) |
Chanrasmey White |
| K171757 |
11/27/2017 |
Straumann Screw Retained Abutments |
Straumann USA, LLC (on behalf of Institut Straumann AG) |
Chanrasmey White |
| K172921 |
11/20/2017 |
Stryker Self-Punching ICONIX |
Stryker |
Katie Farraro |
| K170773 |
11/08/2017 |
Stryker Universal Mesh |
Stryker |
Gregory Gohl |
| K170725 |
11/13/2017 |
Stryker Universal Mesh |
Stryker |
Jonathan Schell |
| K161514 |
01/17/2017 |
Precision Thin Reciprocating Blade, 0.010in. |
STRYKER CORPORATION |
Joanna McCarthy |
| K173135 |
11/27/2017 |
VariAx 2 System |
Stryker GmbH |
Paul Nelson |
| K172856 |
11/16/2017 |
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K162223 |
01/04/2017 |
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) |
SUPERVISION OPTIMAX SDN BHD |
YAP PEAK GEEH |
| K171911 |
11/09/2017 |
Medline ReNewal Reprocessed Synthes External Fixation Systems |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K153587 |
01/18/2017 |
Taps for Resorbable Screws |
SYNTHES (USA) PRODUCTS LLC |
Susan Lewandowski |
| K172157 |
11/14/2017 |
DePuy Synthes Femoral Recon Nail System |
Synthes (USA) Products, LLC |
Alexander Zwahlen |
| K172604 |
11/06/2017 |
XW-100 Automated Hematology Analyzer for CLIA Waived Use |
Sysmex America, Inc. |
Michelle Abraham |
| K162242 |
01/19/2017 |
Comfort Flo Humidification System |
TELEFLEX MEDICAL, INC |
BRIAN GALL |
| K172124 |
11/09/2017 |
Televere Podiatry Digital Imaging System |
Televere Systems |
Randell Quaal |
| K163646 |
11/02/2017 |
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator |
Terragene SA |
Maria Victoria Quiroga |
| K172995 |
11/21/2017 |
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath |
Terumo Medical Corporation |
Liang Lu |
| K170915 |
11/21/2017 |
TXM Hydrophilic Guidewire |
Texas Medical Technologies, Inc. |
Aaron Chiu |
| K170914 |
11/21/2017 |
TXM Support Catheter |
Texas Medical Technologies, Inc. |
Ed Anderson |
| K170053 |
11/28/2017 |
Meridian PM |
The Center for Craniofacial & Dental Sleep Medicine |
Samuel Cress |
| K172407 |
11/02/2017 |
Duracetal |
The Myerson Company Limited |
Cindy Buchoon-Legendre |
| K162387 |
01/11/2017 |
U-IGNITE Bladeless Trocar |
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. |
TAO FAN |
| K171226 |
11/28/2017 |
TOKUYAMA UNIVERSAL BOND |
Tokuyama Dental Corporation |
Fumia Takahashi |
| K171370 |
11/01/2017 |
IMAGEnet 6 Ophthalmic Data System |
Topcon Corporation |
James Lorkowski |
| K171488 |
11/27/2017 |
PSLT for PASCAL Streamline |
Topcon Medical Laser Systems, Inc. |
Sweta Srivastava |
| K172878 |
11/17/2017 |
Vantage Titan 3T, MRT-3010/A7, M-Power GX |
Toshiba Medical Systems Corporation, Japan |
Paul Biggins |
| K172178 |
11/16/2017 |
Minimally Invasive Bunion Plating System |
Trilliant Surgical, LTD |
Jonathan Olson |
| K170578 |
11/24/2017 |
True Function Adjustable Herbst Appliances |
True Function Laboratory, Inc. |
Frank Madrigal |
| K170545 |
11/21/2017 |
Automatic Wrist Bluetooth Blood Pressure Monitor |
Truly Instrument Ltd. |
Yang Jian-Hao |
| K172241 |
11/20/2017 |
Tyece OTC EMS System, Model EM35 |
Tyece Ltd. |
Parshid Falahati |
| K172424 |
11/22/2017 |
VelofixÖ SA Cervical Cage |
U&I Corporation |
Jee-Ae Bang |
| K171392 |
11/09/2017 |
ulrichINJECT CT motion |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K163424 |
01/04/2017 |
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON |
United State Endoscopy Group, Inc. |
Ganga Kolli |
| K163492 |
01/06/2017 |
Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear |
United states Endoscopy Group, Inc. |
Carroll Martin |
| K162812 |
11/01/2017 |
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc |
UNOMEDICAL A/S |
John M. Lindskog |
| K162472 |
01/19/2017 |
TrueBeam-TrueBeam STx-Edge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K170544 |
11/17/2017 |
Langston dual lumen catheter |
Vascular Solutions, Inc. |
Jake Schultz |
| K163444 |
01/06/2017 |
Spectre guidewire |
Vascular Solutions, Inc. |
Beka Vite |
| K163705 |
01/24/2017 |
EzRay Air W |
Vatech Co., Ltd |
Daniel Kim |
| K162765 |
01/11/2017 |
Venus Velocity Diode Laser System |
Venus Concept Ltd. |
Tal Bresler-Stramer |
| K172111 |
11/22/2017 |
Vevazz LED |
Vevazz, LLC |
Jamie Fettig |
| K162763 |
01/05/2017 |
Vevazz LED Heat Lamp |
Vevazz, LLC |
Jamie Fettig |
| K170859 |
11/14/2017 |
Dolphin/IQ and Dolphin/4D |
Viasonix Ltd. |
Dan Manor |
| K163472 |
11/16/2017 |
Intra.Ox Handheld Tissue Oximeter |
VIOPTIX, INC. |
MARK LONSINGER |
| K173086 |
11/07/2017 |
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses |
Visioneering Technologies, Inc. |
Stephen Snowdy |
| K163453 |
11/02/2017 |
VitalPatch« VitalConnect Platform |
VITAL CONNECT, INC. |
KEVIN POTGIETER |
| K163574 |
01/26/2017 |
Multi Modality Viewer |
Vital Images, Inc. |
Susan Atwood |
| K172050 |
11/21/2017 |
Follicle Aspiration Set, Reduced Single Lumen |
Vitrolife Sweden AB |
Anja Bengtzelius |
| K162137 |
01/19/2017 |
Fever ScoutÖ Continuous Monitoring thermometer |
VivaLnk Inc. |
Cecilia Xi |
| K171815 |
11/15/2017 |
Registrado Scan |
VOCO GmbH |
M. Th. Plaumann |
| K172177 |
11/07/2017 |
Insulia Diabetes Management Companion |
Voluntis S.A. |
Kevin Howard |
| K162663 |
01/17/2017 |
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
| K162532 |
01/12/2017 |
WellDoc BlueStar, WellDoc BlueStar Rx |
WELLDOC, INC |
DANIELLE DORFMAN |
| K172794 |
11/29/2017 |
Suction Irrigation Set |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. |
Haobin Li |
| K172584 |
11/20/2017 |
Gⁿnther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gⁿnther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K172557 |
11/20/2017 |
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K173265 |
11/07/2017 |
UltraVision 2 Diagnostic Ultrasound System |
WinProbe Corporation |
Guy Scott |
| K163368 |
01/26/2017 |
FITBONE TAA |
WITTENSTEIN intens GmbH |
Hartmut Kampa |
| K163044 |
01/26/2017 |
ORTHOLOC« 3Di Ankle Fracture Plating System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Val Myles |
| K161823 |
01/23/2017 |
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs |
WRP ASIA PACIFIC SDN BHD |
SARALA DEVI JAYARAMAN |
| K171044 |
11/21/2017 |
Climax Personal Lubricant |
WSM Investment LLC, dba Topco Sales |
Adrian Mendoza |
| K161091 |
01/18/2017 |
STIMPOD NMS460 Nerve Stimulator |
XAVANT TECHNOLOGY (PTY) LTD |
Roche Janse van Rensberg |
| K171961 |
11/17/2017 |
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) |
Xiamen Compower Medical Tech. Co. Ltd. |
Lifen Chen |
| K172144 |
11/01/2017 |
CoolSculpting System |
ZELTIQ Aesthetics |
Ewald Riechert |
| K171873 |
11/15/2017 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs |
Zhonghong Pulin Medical Products Co., Ltd. |
Jinge Li |
| K162489 |
01/13/2017 |
RED Light Device |
Zhongshan Bisen Plastic Electronic Products Co.,Ltd. |
FengPing Li |
| K172767 |
11/30/2017 |
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid |
Zimmer, Inc. |
Ehab Esmail |
| K161652 |
11/28/2017 |
DIAZIR |
ZXTGY (BEIJING) TECHNOLOGY CO., LTD |
N/A N/A |
