| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K170754 |
11/21/2017 |
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing |
3M Company, 3M Health Care |
Maria Ruiz |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K173016 |
11/15/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| 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 |
| K171365 |
11/07/2017 |
Arthrex Knee Systems |
Arthrex Inc. |
David L. Rogers |
| K170206 |
11/15/2017 |
Arthrex FiberTape Cerclage |
ARTHREX, INC. |
IVETTE GALMEZ |
| K171482 |
11/16/2017 |
NEPHROCHECK Test System |
Astute Medical, Inc. |
Karin Hughes |
| 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 |
| 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 |
| K170524 |
11/13/2017 |
Access AMH |
Beckman Coulter, Inc. |
Debbie Kidder |
| K171026 |
11/01/2017 |
Mytens Model: BW-TSX |
Bewell Connect Corp. |
Jacob Chen |
| 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 |
| K172771 |
11/29/2017 |
Epic Pro 940 |
Biolase, Inc |
Alicia Mszyca |
| K173372 |
11/24/2017 |
ExactechGPS Total Shoulder Application |
Blue Ortho |
Anthony Boyer |
| 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 |
| K172446 |
11/07/2017 |
SPIRA-C Open Matrix Cervical Interbody |
Camber Spine Technologies |
Michael Black |
| K171270 |
11/17/2017 |
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS |
Canon, Inc |
SHINJI MORI |
| K170405 |
11/02/2017 |
BD Curve Ascites Shunt |
CareFusion |
Tamara Brey |
| K172609 |
11/03/2017 |
CSMC Cardiac Suite |
Cedars-Sinai Medical Center |
Geoff Pollard |
| K173006 |
11/28/2017 |
Cefaly Dual |
CEFALY Technology |
Jean-Yves Mignolet |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K172757 |
11/02/2017 |
Valleylab FX8 Electrosurgical Platform |
Covidien llc |
Sharon McDermott |
| K172128 |
11/22/2017 |
EsoFLIP« ES-310 Balloon Catheter |
Crospon Ltd. |
John OÆDea |
| K172769 |
11/30/2017 |
CryOmega Flexx |
CryoConcepts LP |
R Sam Niedbala |
| K171473 |
11/07/2017 |
CompressynÖ Staple |
Dallen Medical, Inc. |
Al Memmolo |
| 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 |
| 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 |
| 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 |
| 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 |
| DEN170041 |
11/29/2017 |
GeneSTAT.MDx Coccidioides Assay |
DxNA, LLC |
Ernie Sumsion |
| K173034 |
11/14/2017 |
FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) |
Echosens |
Karine Bonenfant |
| K173003 |
11/15/2017 |
U50 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Alice Yang |
| 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 |
| K172703 |
11/13/2017 |
Disposable Snap Electrode |
Embla Systems |
Sanjay Mehta |
| K171534 |
11/08/2017 |
SurgicalPreview |
Endo Vantage, LLC |
Robert S. Green |
| 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 |
| 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 |
| K172260 |
11/06/2017 |
Omni Foot Plating System |
Extremity Medical, LLC. |
Brian Smekal |
| K171467 |
11/09/2017 |
BioZorb Marker GOLD / LP Marker GOLD |
Focal Therapeutics |
George Hermann |
| 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 |
| 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 |
| 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 |
| K172712 |
11/06/2017 |
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler |
GRI Medical & Electronic Technology Co, Ltd |
Marty D. Paugh |
| 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 |
| 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 |
| 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 |
| K171803 |
11/29/2017 |
HIVOX OTC Electrical Stimulator |
Hivox Biotek Inc. |
Linda Lin |
| K170353 |
11/01/2017 |
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT |
HORIBA ABX SAS |
Caroline Ferrer |
| 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 |
| K173273 |
11/09/2017 |
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI |
Imaging Dynamics Company Ltd. |
Nicole Wherry |
| 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 |
| 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 |
| 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 |
| 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 |
| K172639 |
11/03/2017 |
PALLAS 308/311 Solid-State UV Laser System |
Laseroptek Co.Ltd |
Hong Chu |
| 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 |
| K171136 |
11/20/2017 |
LIA Pregnancy Test |
LIA Diagnostics |
Anna Couturier |
| K170473 |
11/08/2017 |
C2 femoral stem |
Limacorporate S.p.A. |
Antonio Soleti |
| K173171 |
11/24/2017 |
FilmArray RP2/RP2plus Control Panel |
Maine Molecular Quality Controls, Inc. |
Joan Gordon |
| 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 |
| K170513 |
11/01/2017 |
MAUSER PG II Sharps Container |
Mauzer USA LLC |
Tatiana Smoleeva |
| 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 |
| 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 |
| K163595 |
11/13/2017 |
IMPIX 3D Print Cages |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| 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 |
| 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 |
| K172277 |
11/03/2017 |
Phlebo Press DVT Model |
Mego Afek AC Ltd. |
Reuven Yunger |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K172711 |
11/03/2017 |
Comet-PLUS |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| 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 |
| 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 |
| K171466 |
11/29/2017 |
NobelDesign, DTX Studio Design |
Nobel Biocare AB |
Charlemagne Chua |
| K170464 |
11/07/2017 |
StatStrip Xpress Blood Glucose Monitoring System |
Nova Biomedical Corporation |
Eliza Wang |
| 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 |
| 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 |
| 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 |
| K173051 |
11/16/2017 |
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL |
Orthofix Srl |
Gianluca Ricadona |
| 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 |
| K172176 |
11/21/2017 |
Parkell Universal Adhesive |
Parkell, Inc. |
David Mott |
| K172685 |
11/21/2017 |
LiverMultiScan |
Perspectum Diagnostics Ltd |
Jaco Jacobs |
| 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 |
| K172822 |
11/22/2017 |
Azurion series R1.2 |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| 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 |
| K173446 |
11/17/2017 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K171350 |
11/29/2017 |
Collision Check |
Radformation, Inc. |
Kurt Sysock |
| K173233 |
11/30/2017 |
ReliefBand 1.5 |
ReliefBand Technologies |
Dave Hartman |
| K171543 |
11/16/2017 |
Renovis Surgical Hip Replacement System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K170853 |
11/02/2017 |
InnoSpire Go |
Respironics Respiratory Drug Delivery (UK) Ltd. |
Filippo Quadrelli |
| 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 |
| 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 |
| 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 |
| K173378 |
11/20/2017 |
syngo«.via protoNeo (Version VA20) |
Siemens Healthcare GmbH |
Abhineet Johri |
| K172531 |
11/14/2017 |
Biograph mMR with mMR Angio Transfer Option |
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 |
| 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 |
| 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. |
| 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 |
| 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 |
| K163634 |
11/06/2017 |
External Hex Implants |
SOUTHERN IMPLANTS (PTY) LTD |
LAURANDA BREYTENBACH |
| K172687 |
11/27/2017 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
Stephanie Byrum |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K171911 |
11/09/2017 |
Medline ReNewal Reprocessed Synthes External Fixation Systems |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| 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 |
| 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 |
| 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 |
| 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 |
| K170544 |
11/17/2017 |
Langston dual lumen catheter |
Vascular Solutions, Inc. |
Jake Schultz |
| K172111 |
11/22/2017 |
Vevazz LED |
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 |
| K172050 |
11/21/2017 |
Follicle Aspiration Set, Reduced Single Lumen |
Vitrolife Sweden AB |
Anja Bengtzelius |
| K171815 |
11/15/2017 |
Registrado Scan |
VOCO GmbH |
M. Th. Plaumann |
| K172177 |
11/07/2017 |
Insulia Diabetes Management Companion |
Voluntis S.A. |
Kevin Howard |
| 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 |
| K171044 |
11/21/2017 |
Climax Personal Lubricant |
WSM Investment LLC, dba Topco Sales |
Adrian Mendoza |
| 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 |
| 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 |
