| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K172392 |
08/08/2017 |
Lateral Spinal Truss System (LSTS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K172394 |
08/08/2017 |
Steerable Guide Catheter |
Abbott Vascular |
Makena Mc Gowan |
| K172399 |
08/08/2017 |
MicroMatrix |
ACell, Inc. |
Salman Elmi |
| K172603 |
08/30/2017 |
Cerafix Dura Substitute |
Acera Surgical, Inc. |
Matthew MacEwan |
| K172512 |
08/21/2017 |
ACRO HCG Pregnancy Rapid Test |
ACRO Biotech, Inc. |
Joseph Fan |
| K172556 |
08/24/2017 |
TubeClear System |
Actuated Medical, Inc. |
Michael T. Britton |
| K172324 |
08/01/2017 |
Axiostat Chitosan Hemostatic Dressing |
Advamedica Inc. |
Leo Mavely |
| K172388 |
08/08/2017 |
VPOD ITPR |
Advanced Circulatory System, a wholly owned subsidiary of |
Anja Metzger |
| K172529 |
08/21/2017 |
Vivaer ARC Stylus |
Aerin Medical, Inc. |
Shannon Scott |
| K172348 |
08/03/2017 |
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 |
Aesku Diagnostics GmbH & Co. KG |
Sandra Reuter |
| K172461 |
08/14/2017 |
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin |
Aesku.Diagnostics GmbH & Co. KG |
Sandra Reuter |
| K172508 |
08/21/2017 |
Ageless Health Medical Digital Thermometer |
Ageless Health Industrial Co., Ltd |
Victor Wan |
| K172600 |
08/30/2017 |
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal |
Alcon Laboratories, Inc. |
Martina Heim |
| K172479 |
08/16/2017 |
Amsel Occluder Device |
Amsel Medical |
Raanan Miller |
| K172486 |
08/17/2017 |
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chlo |
Anexa Biomedical, Inc. |
Lenny Budloo |
| K172494 |
08/18/2017 |
PROTEUS PTA Balloon Catheter with Embolic Capture Feature |
Angioslide, Ltd. |
Eran Vickus |
| K172430 |
08/11/2017 |
ArgenIS Titanium Abutments |
Argen Corporation |
Paul Cascone |
| K172318 |
08/01/2017 |
Endoform Silver Dermal Template |
Aroa Biosurgery |
Tina O'Brien |
| K172314 |
08/01/2017 |
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) |
Art Optical Contact Lens Inc |
Mike Johnson |
| K172612 |
08/31/2017 |
FiberTak DX |
Arthex, Inc |
Ivette Galmez |
| K172371 |
08/07/2017 |
Arthrex UNIVERS REVERS COATED BASEPLATE |
Arthrex, Inc. |
Courtney Smith |
| K172383 |
08/08/2017 |
Arthrosurface Bone Screws |
Arthrosurface, Inc. |
Dawn J. wilson |
| K172334 |
08/02/2017 |
OrtusÖ Expandable Lumbar Interbody Fusion System |
Atlas Spine, Inc. |
Thomas Smith |
| K172493 |
08/18/2017 |
EnsoETM |
Attune Medical |
Erik Kulstad |
| K172427 |
08/10/2017 |
AViTA Radar Thermo NT16 Series IR Thermometer |
Avita Corporation |
Steven Jhou |
| K172412 |
08/10/2017 |
BacterioScan 216Dx System |
BacterioScan, Inc. |
Rhonda Soest |
| DEN170045 |
08/28/2017 |
Banyan BTI |
Banyan Biomarkers, Inc. |
Steven P. Richieri |
| K172575 |
08/28/2017 |
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap |
BAROnova, Inc. |
Lian Cunningham |
| K172544 |
08/23/2017 |
IV Fat Emulsion Administration Sets |
Baxter Healthcare Corporation |
Jill M. Laack |
| K172337 |
08/02/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) |
Beckman Coulter, Inc. |
Teresa S. Wong |
| K172506 |
08/18/2017 |
BD Cathena Safety IV Catheter |
Becton, Dickinson and Company |
Henry Boland |
| K172366 |
08/04/2017 |
Wrist Pulse Oximeter |
Beijing Choice Electronic Technology Co., Ltd. |
Lei Chen |
| K172543 |
08/23/2017 |
High-speed Turbine Handpieces for Single Use |
Beijing Dongbo Dental Handpiece Co., Ltd. |
Chengfei Yan |
| K172616 |
08/31/2017 |
Pulse Oximeter |
Beijing Safe Heart Technology Ltd. |
Xiaoming Yang |
| K172576 |
08/28/2017 |
BioHorizons Tapered Short Implants |
BioHorizons Implant Systems, Inc. |
Michael Davis |
| K172408 |
08/09/2017 |
Biomet Bone Cement R |
Biomet Inc |
Heidi Busz |
| K172502 |
08/18/2017 |
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate |
Biomet Manufacturing Corp |
Patricia Sandborn Beres |
| K172372 |
08/07/2017 |
QuadraSphere Microspheres |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K172311 |
08/01/2017 |
BioFlux Device |
Biotricity Inc. |
Spencer LaDow |
| K172390 |
08/08/2017 |
Optima Coil System |
Blockade Medical, LLC (d.b.a. Balt USA) |
Rebecca K. Pine |
| K172330 |
08/02/2017 |
Blustone Synergy Silica System |
Blustone Synergy |
Lisa Peterson |
| K172565 |
08/25/2017 |
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device |
Boston Scientific Corporation |
Anand Patel |
| K172520 |
08/21/2017 |
CRE RX Biliary Balloon Dilatation Catheter |
Boston Scientific Corporation |
Jia Huang |
| K172591 |
08/29/2017 |
Fixed Patient Leads ECG Cable (Model 3153) |
Boston Scientific Corporation |
Elizabeth A. Lisowski |
| K172453 |
08/14/2017 |
WATCHDOG Hemostasis Valve Kit |
Boston Scientific Corporation |
Lori Berends |
| K172571 |
08/28/2017 |
ULTRASCORE Focused Force PTA Balloon |
C.R. Bard |
Jonathan Holmes |
| K172511 |
08/21/2017 |
Hickman TriFusion Catheter |
C.R. Bard, Inc |
Mona Shahrebani |
| K172397 |
08/08/2017 |
Sherlock 3CG Tip Positioning System Stylet |
C.R. Bard, Inc. |
Mona Shahrebani |
| K172614 |
08/31/2017 |
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic |
Caldera Medical, Inc. |
Vicki Gail |
| K172446 |
08/14/2017 |
SPIRA-C Open Matrix Cervical Interbody |
Camber Spine Technologies |
Michael Black |
| K172581 |
08/28/2017 |
CareView 1800Cw X-ray Flat Panel Detectors |
CareRay Digital Medical System Co., Ltd. |
Xu Wei |
| K172609 |
08/31/2017 |
CSMC Cardiac Suite |
Cedars-Sinai Medical Center |
Geoff Pollard |
| K172525 |
08/21/2017 |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Central Medicare Sdn. Bhd. |
Arivalagan Subramaniam |
| K172561 |
08/25/2017 |
Disposable Circular Stapler |
Changzhou Kangdi Medical Stapler Co., Ltd. |
Eve Zhou |
| K172538 |
08/22/2017 |
Disposable Linear Stapler, Disposable Linear Cutter |
Changzhou Kangdi Medical Stapler Co.,Ltd. |
Eve Zhou |
| K172465 |
08/14/2017 |
IdysÖ TLIF 3DTi Cages |
CLARIANCE, SAS |
Pascal Rokegem |
| K172385 |
08/08/2017 |
Clarius Ultrasound System |
Clarius Mobile Health Corp. |
Abhijit Ahir |
| K172490 |
08/17/2017 |
eUnity |
Client Outlook Inc. |
Christie Eby |
| K172537 |
08/22/2017 |
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K172516 |
08/21/2017 |
SurgiQuest AIRSEAL iFS System |
ConMed Corporation |
Lisa Anderson |
| K172527 |
08/21/2017 |
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe |
Cook Incorporated |
Rebecca Odulio (Li-chun Liu) |
| K172588 |
08/29/2017 |
Balloon Catheter and Balloon Ureteral Dilator Set |
Cook Incorporated |
Carly Powell |
| K172325 |
08/01/2017 |
Rhapsody H-30 Holmium Laser System |
Cook Incorporated |
Colin Jacob |
| K172321 |
08/01/2017 |
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters |
Cook Incorporated |
Naomi Funkhouser |
| K172551 |
08/23/2017 |
Trinity PLUS Acetabular Shell |
Corin USA Limited |
Rachel King |
| K172361 |
08/04/2017 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Sarah Tang |
| K172482 |
08/16/2017 |
The Nellcor pulse oximetry monitor interface cable |
Covidien |
Mia M. Ware |
| K172432 |
08/11/2017 |
SporView Rapid Read Biological Indicator |
Crosstex/SPSmedical, A Division of Cantel Medical |
Megan Skaar |
| K172601 |
08/30/2017 |
Next Generation iBOT |
DEKA Research & Development Corp |
Roger Leroux |
| K172457 |
08/14/2017 |
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM |
Deltex Medical Limited |
Mark Baylis |
| K172398 |
08/08/2017 |
DENTCA DENTURE Teeth |
DENTCA, INC. |
Jason Lee |
| K172381 |
08/07/2017 |
Digitimer DS7AP Constant Current Stimulator |
Digitimer Ltd. |
John Smale |
| K172440 |
08/11/2017 |
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 |
Dongguan Prestige Sporting Goods., Ltd. |
Zhang Zhao |
| K172481 |
08/16/2017 |
IntelliCart System |
Dornoch Medical Systems |
Larry Smith |
| DEN170043 |
08/17/2017 |
DreaMed Advisor Pro |
DreaMed Diabetes, Ltd. |
Eran Atlas |
| DEN170041 |
08/01/2017 |
GeneSTAT.MDx Coccidioides Assay |
DxNA, LLC |
Ernie Sumsion |
| K172380 |
08/07/2017 |
U2 Diagnostic Ultrasound System |
Edan Instruments Inc |
Alice Yang |
| K172423 |
08/10/2017 |
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) |
Edwards Lifescience LLC |
Bedalin T. Lugo Rodriguez |
| K172312 |
08/01/2017 |
eego amplifiers |
eemagine Medical Imaging Solutions GmbH |
Frank Zanow |
| K172362 |
08/04/2017 |
DEKA SMARTXIDE TOUCH |
EL.EN Electronic Engineering Spa |
Paolo Peruzzi |
| K172363 |
08/04/2017 |
DEKA SMARTXIDE ULTRASPEED |
EL.EN. Electronic Engineering Spa |
Paolo Peruzzi |
| K172351 |
08/03/2017 |
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert |
Encore Medical, L.P. |
Teffany Hutto |
| K172346 |
08/03/2017 |
sterEOS Workstation |
EOS imaging |
Mathias Breuil |
| K172441 |
08/11/2017 |
EPIC Extremity Fracture Plate System |
EPIC Extremity, LLC |
Dan Schwartzbauer |
| K172580 |
08/28/2017 |
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 |
| K172582 |
08/28/2017 |
EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern |
Euroimmun US, Inc. |
Michael A. Locke |
| K172357 |
08/03/2017 |
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow |
EVER GROWTH (VIETNAM) CO., LTD |
Che-Min Lee |
| K172364 |
08/04/2017 |
EzDent-i / E2 / Prora View |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K172602 |
08/30/2017 |
Miracu |
Feeltech Co., Ltd. |
Keun-Sik Kim |
| K172570 |
08/28/2017 |
ALGS6 Ag Alginate Wound Dressing |
Foshan United Medical Technologies, Ltd. |
Una Chen |
| K172487 |
08/17/2017 |
Coaxial Dilator Set (Micro-Introducer) |
Galt Medical Corp. |
David Derrick |
| K172382 |
08/08/2017 |
GC Fuji Direct |
GC America Inc. |
Mark Heiss |
| K172404 |
08/09/2017 |
SenoBright HD |
GE Healthcare |
Mounir Zaouali |
| K172342 |
08/02/2017 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K172550 |
08/23/2017 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Rachel Schandel |
| K172569 |
08/25/2017 |
GenePOC CDiff |
GenePOC Inc. |
Guy Sevigny |
| K172469 |
08/15/2017 |
TiLock Modular Spinal System |
Genesys Spine |
Brian J. Bergeron |
| K172414 |
08/10/2017 |
JUD custom fit condom |
Global Mailer Partners, LLC |
Jud Ireland |
| K172438 |
08/11/2017 |
ARBOR External Fixation System |
Globus Medical Inc. |
Kelly J. Baker |
| K172417 |
08/10/2017 |
SILC« Fixation System |
Globus Medical Inc. |
Lori Burns |
| K172403 |
08/09/2017 |
GSI Novus |
Grason-Stadler Inc. |
Amy Yanta |
| K172445 |
08/14/2017 |
RoyalGuard Surgical Gown, i600, Breathable |
GRI Medical & electrical Technology Co., Ltd |
Martin D. Paugh |
| K172546 |
08/23/2017 |
AnyPlus« Spinal Fixation System |
GS Medical Co., Ltd. |
Marcin Niemiec |
| K172368 |
08/07/2017 |
Bipolar Micro-Coagulation Forceps |
Gunter Bissinger Medizintechnik GmbH |
Matthias Bissinger |
| K172621 |
08/31/2017 |
HardyDisk Meropenem/Vaborbactam 20/10?g (MEV30) |
Hardy Diagnostics |
Andre Hsiung |
| K172442 |
08/11/2017 |
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 |
| K172492 |
08/17/2017 |
Optical Topography System ETG-4100 |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K172566 |
08/25/2017 |
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices |
Hologic, Inc. |
Catherine Sanford |
| K172554 |
08/24/2017 |
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
Huida Huang |
| K172491 |
08/17/2017 |
ICONN Square 2.5MM Suture Anchor |
ICONN Orthopedics, LLC |
Whitt Israel |
| K172480 |
08/16/2017 |
icotec Interbody Cage System |
icotec ag |
Valeria Consiero |
| K172507 |
08/18/2017 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K172389 |
08/08/2017 |
ePTFE-Coated Auricular Implant |
Implantech Associates Inc. |
Craig Arthur |
| K172416 |
08/10/2017 |
Synermed Opiate Enzyme Immunoassay |
Infrared Laboratory Systems, LLC (dba Synermed) |
Julie Paschal |
| K172468 |
08/15/2017 |
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm |
InNeuroCo, Inc |
Marc Litzenberg |
| K172595 |
08/29/2017 |
CUSA Excel+ Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K172329 |
08/02/2017 |
Patient Status Engine |
Isansys Lifecare Ltd |
Julian Jones |
| K172477 |
08/16/2017 |
iSchemaView RAPID |
iSchemaView, Inc. |
Jim Rosa |
| K172598 |
08/29/2017 |
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE |
ITW Contamination Control Electronics |
Steve Cook |
| K172499 |
08/18/2017 |
NEOSHIELD |
JMS North America Corporation |
Sho Hosoki |
| K172513 |
08/21/2017 |
3D Echo |
JointVue LLC |
Mohamed R. Mahfouz |
| K172331 |
08/02/2017 |
Type I, Type II, Type III, Type IV |
Lepu Medical Technology (Beijing) Co., Ltd. |
Xiangdan Jin |
| K172456 |
08/14/2017 |
Bone Screws 6.5mm |
LimaCorporate S.p.A. |
Michela Zanotto |
| K172542 |
08/23/2017 |
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. |
Liofilchem s. r. l. |
Fabio Brocco |
| K172402 |
08/09/2017 |
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit |
Luminex Corporation |
Jennifer Grimes |
| K172413 |
08/10/2017 |
MT ONE |
M&T S.R.L |
Fiorenzo Rossi |
| K172522 |
08/21/2017 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K172460 |
08/14/2017 |
ADHEAR System |
MED-EL Elektromedizinische Geraete GmbH |
Elizabeth Gfoeller |
| K172347 |
08/03/2017 |
GMK Hinge, GMK Revision |
Medacta International SA |
Stefano Baj |
| K172587 |
08/28/2017 |
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers |
Medacta International SA |
Stefano Baj |
| K172344 |
08/02/2017 |
Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) |
MEDAX S.R.L. UNIPERSONALE |
Stefano Cavalieri |
| K172435 |
08/11/2017 |
Galaxy R Digital Radiography Upgrade |
MEDIEN INTERNATIONAL CO LTD |
Jae Hyun Lee |
| K172541 |
08/23/2017 |
Medline Catheter Specimen Collector |
Medline Industries, Inc. |
Dinah Rincones |
| K172373 |
08/07/2017 |
Compound W Nitro-Freeze |
Medtech Products Inc. |
Jean Boyko |
| K172444 |
08/14/2017 |
ROSA BRAIN (v3.0.0.5) |
MEDTECH S.A. |
Elise Lagacherie |
| K172328 |
08/02/2017 |
SOVEREIGNÖ Spinal System |
Medtronic Sofamor Danek |
Kanesha Hines |
| K172448 |
08/14/2017 |
Riptide Aspiration System |
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
Ryan Kenney |
| K172498 |
08/18/2017 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K172505 |
08/18/2017 |
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K172464 |
08/14/2017 |
XD880A Ultrasonic Osteotomy Surgical System |
Morley Research Consortium |
Suzan Davis |
| K172620 |
08/31/2017 |
SyndesMetrics Syndesmosis Repair System |
Mortise Medical LLC |
Robert Hoy |
| K172422 |
08/10/2017 |
Kohli Urinary Drainage Catheter |
Nellie Medical, LLC |
Ronald Adams |
| K172359 |
08/04/2017 |
UroLift System (UL500) |
NeoTract, Inc. |
Louis-Pierre Marcoux |
| K172539 |
08/23/2017 |
CereTom Elite |
NeuroLogica Corporation, a Subsidiary of Samsung Electronics |
Ninad Gujar |
| K172320 |
08/01/2017 |
Neurostructures Cavetto« Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K172485 |
08/17/2017 |
Footmotion HammerToe |
Newclip Technics |
Gaelle Lussori |
| K172596 |
08/29/2017 |
Large Screws Range |
Newclip Technics |
Gaelle Lussori |
| K172433 |
08/11/2017 |
NICO BrainPath |
NICO Corporation |
Sean Spence |
| K172352 |
08/03/2017 |
TREFOIL System |
Nobel Biocare AB |
Charlemagne Chua |
| K172418 |
08/10/2017 |
OpenSight |
Novarad Corporation |
Doug Merrill |
| K172497 |
08/18/2017 |
NuVasive AttraX Scaffold |
NuVasive, Incorporated |
Marysa E. Loustalot |
| K172341 |
08/02/2017 |
NuVasive« Modulus TLIF Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K172618 |
08/31/2017 |
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172610 |
08/31/2017 |
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172535 |
08/22/2017 |
Bipolar applicator CELON ProCurve V |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K172555 |
08/24/2017 |
SAPPHIRE, ELEVARE SAPPHIRE |
Omm Imports, Inc. d/b/a Zero Gravity |
Zivan Habibi |
| K172323 |
08/01/2017 |
Omnia Medical VBR |
Omnia Medical, LLC |
Troy Schifano |
| K172467 |
08/15/2017 |
OMNI ARC Anteverted Neck Hip Stem |
OMNIlife science |
Christina Rovaldi |
| K172462 |
08/14/2017 |
OrthAlign Plus System |
OrthAlign, Inc. |
David Vancelette |
| K172327 |
08/01/2017 |
VMAÖ System version 3.0 |
Ortho Kinematics, Inc. |
Adam Deitz |
| K172437 |
08/11/2017 |
CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K172583 |
08/28/2017 |
OrthoPediatrics PediNail Intramedullary Platform |
OrthoPediatrics, Inc. |
Adam Cargill |
| K172425 |
08/10/2017 |
OrthoPediatrics Wrist Fusion Plate |
OrthoPediatrics, Inc. |
Adam Cargill |
| K172573 |
08/28/2017 |
ReBOSSIS85 |
Orthorebirth Co., Ltd. |
Yasutoshi Nishikawa |
| K172354 |
08/03/2017 |
OssBuilder System |
Osstem Implant Co., Ltd.. |
Jungmin Yoo |
| K172607 |
08/30/2017 |
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
Philips Healthcare |
Maxs Newberry |
| K172406 |
08/09/2017 |
Ingenuity TF |
Philips Medical Systems (Cleveland) Inc. |
Christine Anderson |
| K172431 |
08/11/2017 |
Cardiovascular Analzyer |
PhysioWave, Inc. |
Laurent Giovangrandi |
| K172349 |
08/03/2017 |
InFill« Interbody Fusion Device |
Pinnacle Spine Group, LLC |
Zach Sowell |
| K172365 |
08/04/2017 |
Panoramic Oxygen Mask (POM) |
Pom Medical, LLC |
Jeff Voss |
| K172483 |
08/16/2017 |
Kopac Sterile Needle |
Poonglim Pharmatech Inc. |
Cho Hee Min |
| K172568 |
08/25/2017 |
Cervage |
PRECIFIT MEDICAL LTD |
Zhen Yu (Eric) Wu |
| K172495 |
08/18/2017 |
Reform« POCT System |
Precision Spine, Inc. |
Michael C. Dawson |
| K172358 |
08/03/2017 |
Instalief |
Privi Medical Pte Ltd |
Prusothman M Sinha Raja |
| K172426 |
08/10/2017 |
Clear Blue Digi LED Curing Light |
Promident LLC |
Gary Kris |
| K172534 |
08/22/2017 |
LINACwatch, LinacView |
QualiFormeD Sarl |
Stephane Beaumont |
| K172376 |
08/07/2017 |
Discovery Pico, Discovery Pico Plus |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K172489 |
08/17/2017 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K172503 |
08/18/2017 |
MR Conditional Cup Electrode, MR Conditional Webb Electrode |
Rhythmlink International, LLC |
Daniel McCoy |
| K172343 |
08/02/2017 |
Fortilink« Interbody Fusion (IBF) System with TETRAfuse« 3D Technology |
RTI Surgical, Inc. |
Diana Taylor |
| K172514 |
08/21/2017 |
Trak Plus Male Fertility Testing System |
Sandstone Diagnostics, Inc. |
Ulrich Schaff |
| K172517 |
08/21/2017 |
SeaSpine Navigation System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172530 |
08/21/2017 |
BEAUTIFIL Flow Plus X |
Shofu Dental Corporation |
Mauro Malzyner |
| K172322 |
08/01/2017 |
Atellica IM Total hCG (ThCG) |
Siemens Healthcare Diagnostics Inc. |
Anoop Joy |
| K172333 |
08/02/2017 |
Sysmex CS-5100 |
Siemens Healthcare Diagnostics Products GmbH |
Donna Noeh |
| K172374 |
08/07/2017 |
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K172531 |
08/22/2017 |
Biograph mMR with mMR Angio Transfer Option |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K172452 |
08/14/2017 |
Bruxor |
Sleep Specialties, LLC |
James S. Fallon |
| K172451 |
08/14/2017 |
Dr.MUSIC 3s |
SmartMedicalDevice Co., Ltd. |
Dong-Min Lee |
| K172519 |
08/21/2017 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172521 |
08/21/2017 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172336 |
08/02/2017 |
Smith & Nephew Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
Brad Sheals |
| K172592 |
08/29/2017 |
CADD Yellow High Volume Administration Set with NRFit connector |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K172458 |
08/14/2017 |
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 |
| K172410 |
08/09/2017 |
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K172335 |
08/02/2017 |
Bleep DreamPort |
snapCPAP |
Stuart Heatherington |
| K172395 |
08/08/2017 |
Duatene bilayer mesh |
Sofradim Production |
Benjamin Rochette |
| K172545 |
08/23/2017 |
SERI Contour |
Sofregen Medical, Inc. |
Anh Hoang |
| K172536 |
08/22/2017 |
Atlas Percussion Adjusting Instrument |
Spinalight, Inc |
Stanford Pierce |
| K172594 |
08/29/2017 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K172484 |
08/17/2017 |
A-CIFT SoloFuse |
SpineFrontier, Inc. |
Vito Lore |
| K172518 |
08/21/2017 |
Spineology Navigation Instruments |
Spineology Inc. |
Jacqueline Hauge |
| K172396 |
08/08/2017 |
EnSite Velocity Cardiac Mapping System v5.2 |
St. Jude Medical |
Melissa Frank |
| K172393 |
08/08/2017 |
Advisor HD Grid Mapping Catheter, Sensor Enabled |
St. Jude Medical, Inc. |
Jennifer Ruether |
| K172375 |
08/07/2017 |
MicroSTAAR Injector System Cartridges |
STAAR Surgical Company |
Kate Ueda |
| K172593 |
08/29/2017 |
XCelliStem Wound Powder |
StemSys |
Clay Fette |
| K172319 |
08/01/2017 |
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System |
STERIS Corporation |
Bill Brodbeck |
| K172474 |
08/15/2017 |
Celerity 20 HP Biological Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K172472 |
08/15/2017 |
Micro-MEC 1.8% Glutaraldehyde Monitor Strip |
STERIS Corporation |
Jennifer Nalepka |
| K172315 |
08/01/2017 |
Rotarex S Catheter Set û 6F x 110 cm, Rotarex S Catheter Set û 6F x 135 cm, Rotarex S Catheter Set û 8F x 85 cm, Rotarex S Catheter Set û 8F x 110 cm, Drive System, Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswit |
Straub Medical AG |
Amy Ehlenfeldt |
| K172572 |
08/28/2017 |
Stryker Upper-Face AXS screws and Mid-Face AXS screws |
Stryker |
Jonathan Schell |
| K172558 |
08/24/2017 |
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit |
Stryker Corporation |
Kristi Ashton |
| K172350 |
08/03/2017 |
AxSOS 3 Ti |
Stryker GmbH |
Kemine Hale |
| K172367 |
08/04/2017 |
Stryker Integrated Bipolar Cord and Tubing Sets |
Stryker Instruments |
Susanne Galin |
| K172326 |
08/01/2017 |
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System |
Stryker Orthopaedics |
Margaret Klippel |
| K172384 |
08/08/2017 |
Quickie(r) Q700-UP M |
Sunrise Medical (US) LLC |
Nancy J. Gertlar |
| K172608 |
08/31/2017 |
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K172560 |
08/25/2017 |
PREMIUM ONE Implant Systems |
Sweden & Martina S.p.A |
Alessia Pezzato |
| K172473 |
08/15/2017 |
LifeStyles« SKYN« Intimate Moments Personal Lubricant |
SXWELL USA LLC |
Robert Mahler |
| K172338 |
08/02/2017 |
Catasyn Advanced Technology Wound Hydrogel |
Synedgen, Inc |
Shenda Baker |
| K172604 |
08/30/2017 |
XW-100 Automated Hematology Analyzer for CLIA Waived Use |
Sysmex America, Inc. |
Michelle Abraham |
| K172590 |
08/29/2017 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K172613 |
08/31/2017 |
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit |
The Binding Site Group Ltd. |
Andrea Thomas |
| K172407 |
08/09/2017 |
Duracetal |
The Myerson Company Limited |
Cindy Buchoon-Legendre |
| K172501 |
08/18/2017 |
iNSitu Total Hip System |
Theken Companies, LLC |
Dale Davison |
| K172454 |
08/14/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| DEN170044 |
08/18/2017 |
ClearMate |
Thornhill Research, Inc. |
Kipton Lade |
| K172496 |
08/18/2017 |
SUPERCATH 5 (26G) |
TOGO Medikit Co., Ltd. |
Daisuke Nagamizu |
| K172504 |
08/18/2017 |
Tosama Biobased Applicator Tube Menstrual Tampon |
TOSAMA, d.o.o. |
Marjetka Kralj Kuncic |
| K172617 |
08/31/2017 |
Treace Medical Concepts (TMC) Compression Screw System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K172405 |
08/09/2017 |
SNIPER STAPLE SYSTEM, NON-STERILE |
Trilliant Surgical |
Jon Olson |
| K172409 |
08/09/2017 |
Lite |
Tzora Active Systems Ltd. |
Adi Shemer |
| K172424 |
08/10/2017 |
VelofixÖ SA Cervical Cage |
U&I Corporation |
Jee-Ae Bang |
| K172419 |
08/10/2017 |
VelofixÖ TLIF Cage |
U&i Corporation |
Jee-Ae Bang |
| K172447 |
08/14/2017 |
JO Gelato Flavored Personal Lubricants |
United Consortium |
Stephanie Morris |
| K172585 |
08/28/2017 |
Liberty Anterior Cervical Plate |
Valorus Spine |
Leah Fero |
| K172611 |
08/31/2017 |
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K172533 |
08/22/2017 |
GM Implant Tubes, Length Cutting Gauge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172509 |
08/21/2017 |
Sentosa SA201 HSV 1/2 Qualitative PCR Test |
Vela Diagnostics USA Inc. |
Donald Henton |
| K172471 |
08/15/2017 |
VENTANA CD30 (Ber-H2) RxDx Assay |
Ventana Medical Systems, Inc. |
Jeffrey Catania |
| K172356 |
08/03/2017 |
BladderScan Prime PLUS System |
Verathon Incorporated |
Swapna Chirala |
| K172586 |
08/28/2017 |
Vios Monitoring SystemÖ Model 2050 |
Vios Medical, Inc. |
Amit Patel |
| K172386 |
08/08/2017 |
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System |
Volcano AtheroMed Inc |
Jean Chnag |
| K172455 |
08/14/2017 |
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit |
Volcano Corporation |
Courtney Moore |
| K172574 |
08/28/2017 |
SyncVision System |
Volcano Corporation |
Elaine Alan |
| K172439 |
08/11/2017 |
Siberian Fit |
Vydence |
Kevin Walls |
| K172567 |
08/25/2017 |
GORE Molding and Occlusion Balloon Catheter |
W.L Gore And Associates Inc |
Jeremiah Andrews |
| K172345 |
08/02/2017 |
IU Implant System |
Warantec Co.,Ltd. |
Dong-Hwa Jang |
| K172478 |
08/16/2017 |
TENS device-EmeTerm, CinvStop |
WAT Medical Technology (Ningbo) Co., Ltd |
Rodney Zhang |
| K172450 |
08/14/2017 |
TENS device-HeadaTerm, eEspress |
WAT Medical Technology (Ningbo) Co., Ltd |
Rodney Zhang |
| K172420 |
08/10/2017 |
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Wear Safe (Malaysia) Sdn. Bhd. |
Cho Sow Fong |
| K172578 |
08/28/2017 |
Equipment Pouch |
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K172584 |
08/28/2017 |
G?nther Tulip Vena Cava Filter Set for Femoral Vein Approach, G?nther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K172557 |
08/24/2017 |
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 |
| K172548 |
08/23/2017 |
Wiltrom Spinal Fixation System |
Wiltrom Corporation Limited |
Yi-Chun Su |
| K172500 |
08/18/2017 |
Technoweb Surgical Mask |
YTS GLOBAL INC. |
Eddie Nguyen |
| K172524 |
08/21/2017 |
Zimmer Persona Personalized Knee System |
Zimmer, Inc. |
Nicole Meredith |
| K172510 |
08/21/2017 |
?Cor Heart Failure and Arrhythmia Management System |
ZOLL Manufacturing Corporation |
Dawn Chang |
