| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K172388 |
12/22/2017 |
VPOD ITPR |
Advanced Circulatory System, a wholly owned subsidiary of |
Anja Metzger |
| K172931 |
12/01/2017 |
DUS-6000 Digital Ultrasonic Diagnostic Imaging System |
Advanced Instrumentations, Inc. |
Jorge Millan |
| K172966 |
12/08/2017 |
CMS-2000 Central Monitoring System |
Advanced Instumentations, Inc. |
Jorge Millan |
| DEN170075 |
12/19/2017 |
ContainOR |
Advanced Surgical Concepts Ltd. |
Edward Hyland |
| K172529 |
12/05/2017 |
Vivaer ARC Stylus |
Aerin Medical, Inc. |
Shannon Scott |
| K173550 |
12/14/2017 |
Akros FibuLinkÖ Syndesmosis Repair Kit |
Akros Medical |
Charles Horrell |
| K173538 |
12/04/2017 |
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc |
Alcon Laboratories, Inc. |
Katryna Warren |
| K173502 |
12/13/2017 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
Alere Scarborough, Inc. |
Benjamin Crystal |
| K171581 |
12/22/2017 |
Neuro Omega System |
Alpha Omega Engineering Ltd, |
Maysana Mousa |
| K172732 |
12/14/2017 |
E-CUBE 8 |
ALPINION MEDICAL SYSTEMS Co., Ltd. |
Boyeon CHO |
| K170553 |
12/01/2017 |
Altus Spine Interbody Fusion System |
Altus Partners, LLC |
Mark Melton |
| K172908 |
12/07/2017 |
Q-Switched Nd:YAG Laser System |
AMI Inc. |
Hae Youn Lee |
| K171037 |
12/27/2017 |
PoreStar Patient Specific Implant |
Anatomics Pty Ltd |
Joanne Flatley |
| K172494 |
12/15/2017 |
PROTEUS PTA Balloon Catheter with Embolic Capture Feature |
Angioslide, Ltd. |
Eran Vickus |
| K173017 |
12/15/2017 |
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Anhui Kindguard Medical Supplies Technology Co.,Ltd |
Chen Wei |
| K173008 |
12/26/2017 |
SCS 17-01 |
Anika Therapeutics, Inc. |
Steven Chartier |
| K171737 |
12/29/2017 |
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves |
Ansell Healthcare Products LLC |
Robert Mahler |
| K172052 |
12/13/2017 |
Arthrex DynaNite Nitinol Staple |
Arthrex Inc. |
Rebecca R. Homan |
| K170414 |
12/14/2017 |
Arthrex Univers Revers Apex Humeral Stems |
Arthrex Inc. |
David L. Rogers |
| K172383 |
12/22/2017 |
Arthrosurface Bone Screws |
Arthrosurface, Inc. |
Dawn J. wilson |
| K172228 |
12/15/2017 |
pioli IOL Delivery System |
AST Products, Inc. |
William Lee |
| K171584 |
12/22/2017 |
B. Braun Tear-Away Introducer Needle |
B. Braun Medical Inc. |
Kimberly Smith |
| K172922 |
12/21/2017 |
MMPC-4127F1 |
Barco N.V. |
Lieven De Wandel |
| K173480 |
12/11/2017 |
Crystalsert Lens Delivery System |
Bausch & Lomb, Inc |
Gary Rauvola |
| K172912 |
12/07/2017 |
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) |
Beckman Coulter Inc. |
Shannon Popson |
| K172255 |
12/01/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) |
Beckman Coulter, Inc |
Shannon Popson |
| K172337 |
12/15/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) |
Beckman Coulter, Inc. |
Teresa S. Wong |
| K173354 |
12/15/2017 |
BD Nexiva Diffusics Closed IV Catheter Systems |
Becton Dickinson Infusion Therapy Systems, Inc. |
Henry Boland |
| K171061 |
12/28/2017 |
MRSASelect II |
Bio-Rad |
Sylvie Fernez |
| K172731 |
12/08/2017 |
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) |
bioMerieux, Inc. |
Esther Hernandez |
| K172944 |
12/19/2017 |
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL |
bioMerieux, Inc. |
Cherece L. Jones |
| K173374 |
12/13/2017 |
TSV BellaTek Encode Healing Abutments |
Biomet 3i |
Nichole OÆNeil |
| K170138 |
12/26/2017 |
NEURONAUTE |
BIOSERENITY |
Quang TRAN |
| K171185 |
12/01/2017 |
IR Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K172311 |
12/15/2017 |
BioFlux Device |
Biotricity Inc. |
Spencer LaDow |
| K172330 |
12/21/2017 |
Blustone Synergy Silica System |
Blustone Synergy |
Lisa Peterson |
| K172565 |
12/20/2017 |
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 |
| K173251 |
12/19/2017 |
LumiCoil Platinum Fiducial Marker |
Boston Scientific Corporation |
Lindsay Forys |
| K171271 |
12/15/2017 |
Polyform Synthetic Mesh |
Boston Scientific Corporation |
Michelle Berry |
| K172932 |
12/13/2017 |
True Flow Valvuloplasty Perfusion Catheter |
C. R. Bard, Inc. |
Aaron Conovaloff |
| K173652 |
12/28/2017 |
Piccolo Composite Nailing System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K171552 |
12/19/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
Yi-Ping Lin |
| K171186 |
12/08/2017 |
Cerebrotech CMS-5000 |
Cerebrotech Medical Systems |
Dawnel Scott |
| K171956 |
12/12/2017 |
Sterile Endoscope Biopsy Sampling Needle |
Changzhou Detain Medical Devices Co., Ltd. |
Zhengrong Ding |
| K172561 |
12/05/2017 |
Disposable Circular Stapler |
Changzhou Kangdi Medical Stapler Co., Ltd. |
Eve Zhou |
| K171877 |
12/21/2017 |
SLM-1ER, SLM-2ER, SLM-3ER |
Chongqing Kanghua Ruiming S&T Co., Ltd. |
Xi You |
| K172465 |
12/15/2017 |
IdysÖ TLIF 3DTi Cages |
CLARIANCE, SAS |
Pascal Rokegem |
| K171677 |
12/08/2017 |
Clear Guide SCENERGY |
Clear Guide Medical |
Jack Kent |
| K173148 |
12/01/2017 |
ACIF |
coLigne, AG |
Robert Lange |
| K171043 |
12/21/2017 |
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters |
Coloplast Corp |
Cori Ragan |
| K172986 |
12/19/2017 |
Zmachine Synergy |
Consolidated Research of Richmond, Inc. dba General Sleep Co |
Richard Kaplan |
| K172217 |
12/13/2017 |
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath |
Cook Incorporated |
Andrew Breidenbach |
| K171275 |
12/20/2017 |
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design |
Cook Incorporated |
Daniel J. Corbin |
| K173685 |
12/20/2017 |
Peel-Away Introducer Set |
Cook Incorporated |
Colin Jacob |
| K172321 |
12/21/2017 |
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters |
Cook Incorporated |
Naomi Funkhouser |
| K173687 |
12/15/2017 |
Strange Bile Duct Stone Exploration Set |
Cook Incorporated |
Colin Jacob |
| K170898 |
12/12/2017 |
Wittich Nitinol Stone Basket |
Cook Incorporated |
Erum B. Nasir |
| K172707 |
12/05/2017 |
Renamel Microfill |
Cosmedent, Inc |
Mary Nowak |
| K172482 |
12/15/2017 |
The Nellcor pulse oximetry monitor interface cable |
Covidien |
Mia M. Ware |
| K172432 |
12/12/2017 |
SporView Rapid Read Biological Indicator |
Crosstex/SPSmedical, A Division of Cantel Medical |
Megan Skaar |
| K172085 |
12/04/2017 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K171909 |
12/17/2017 |
HAL for Medical Use (Lower Limb Type) |
CYBERDYNE Inc. |
Yohei Suzuki |
| K170005 |
12/21/2017 |
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) |
DAKO DENMARK A/S |
LASSE POST MOLLER |
| K170028 |
12/21/2017 |
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) |
DAKO DENMARK A/S |
Lasse Post Moller |
| K171530 |
12/21/2017 |
Deltaven XiV Max, Deltaven XiV Max FF |
Delta Med SpA |
Raschi Olga |
| K170104 |
12/27/2017 |
COMPACT S, COMPACT S (LED) |
DMETEC CO., LTD. |
Lee Seung Dae |
| K171729 |
12/13/2017 |
Fixtemp C&B |
Dreve Dentamid GmbH |
Reiner Altmann |
| K171174 |
12/18/2017 |
PERIO-FLOW nozzle |
E.M.S. Electro Medical Systems S.A. |
Suzanne Fassio-Hardy |
| K172888 |
12/15/2017 |
EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K172270 |
12/07/2017 |
gammaCore-2 |
eletroCore, LLC |
Mike Romaniw |
| K173073 |
12/26/2017 |
AltiVate Anatomic to Reverse Conversion Module |
Encore Medical, L.P. |
Teffany Hutto |
| K172651 |
12/13/2017 |
FMP Extended Liners |
Encore Medical, L.P. |
Teffany Hutto |
| K172722 |
12/10/2017 |
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) |
EUROIMMUN US, Inc. |
Michael A. Locke |
| K172357 |
12/29/2017 |
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow |
EVER GROWTH (VIETNAM) CO., LTD |
Che-Min Lee |
| K171781 |
12/13/2017 |
eVox System |
Evoke Neuroscience, Inc. |
David Hagedorn |
| K173375 |
12/21/2017 |
Anterior Cervical Plate System |
Evolution Spine, LLC |
Douglas Davis |
| K172960 |
12/21/2017 |
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use |
Ezisurg Medical Co., Ltd. |
Sheng Tian |
| K171193 |
12/18/2017 |
Certa Catheter |
Ferrosan Medical Devices SP. Z O.O. |
Elzbieta Porebska-Guillemant |
| K172819 |
12/01/2017 |
LightWalker Laser System Family |
Fotona d.o.o. |
Marko Berdajs |
| K172238 |
12/14/2017 |
CAREline Airless Hemodialysis Blood Tubing Sets |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K172713 |
12/10/2017 |
Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K171834 |
12/19/2017 |
G Surgical OCT Spinal System |
G Surgical LLC |
Donald Grafton |
| K173287 |
12/21/2017 |
Elite HV Radial |
Galt Medical Corp. |
David Derrick |
| K173555 |
12/20/2017 |
LOGIQ E10 |
GE Healthcare |
Bryan Behn |
| K173612 |
12/11/2017 |
Optima XR646 HD |
GE Hualun Medical Systems Co., Ltd |
Kenny Ma |
| K172010 |
12/07/2017 |
gel-e Bandage |
gel-e, Inc. (formerly Remedium Technologies, Inc.) |
Matthew Dowling |
| K170276 |
12/11/2017 |
Safety Blood Collection Device for Single Use |
Gemtier Medical (Shanghai) Inc. |
Lenny Cao |
| K172714 |
12/08/2017 |
LipiVage |
Genesis Biosystems, Inc. |
Jim Lafferty |
| K171108 |
12/29/2017 |
AUTOBAHN Nailing System |
Globus Medical Inc. |
Kelly J. Baker |
| K173115 |
12/20/2017 |
COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS |
Globus Medical Inc. |
Kelly J. Baker |
| K171848 |
12/21/2017 |
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS |
Globus Medical Inc. |
Lori Burns |
| K172445 |
12/08/2017 |
RoyalGuard Surgical Gown, i600, Breathable |
GRI Medical & electrical Technology Co., Ltd |
Martin D. Paugh |
| K163550 |
12/20/2017 |
Pobling MIITY 2 |
HABALAN MED & BEAUTY CO.,LTD |
RAY JEON |
| K172861 |
12/19/2017 |
Digital thermometer(with disposable thermometer cover) |
Hangzhou Hua'an medical&health instruments Co.,Ltd |
Ahneo Yang |
| K173137 |
12/12/2017 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K171336 |
12/07/2017 |
Cystoscope 4.0mm autoclavable 0░ WL 302mm; Hysteroscope 4.0mm autoclavable 0░ WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath |
Henke-Sass, Wolf GmbH |
Anna Reifschneider |
| K171049 |
12/26/2017 |
Real Time Image Gating System for Proton Beam Therapy Systems |
Hitachi, Ltd. Healthcare |
Tomoyuki Seino |
| K172629 |
12/04/2017 |
Panther Fusion AdV/hMPV/RV Assay |
Hologic, Inc. |
Anila K Tarte |
| K170988 |
12/12/2017 |
DropSafe Safety Pen Needle |
HTL-Strefa S.A. |
Aleksandra Prazmowska-Wilanowska |
| K173131 |
12/08/2017 |
Rexious Spinal Fixation System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K171480 |
12/13/2017 |
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| DEN160062 |
12/19/2017 |
IlluminOss Bone Stabilization System |
IllminOss Medical, Inc. |
Fred Tobia |
| K173038 |
12/01/2017 |
CuRAS Nd:YAG Laser |
Ilooda Co., Ltd. |
Yun-Jung HA |
| K172507 |
12/22/2017 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K173470 |
12/04/2017 |
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath |
Inari Medical |
Eben Gordon |
| K170881 |
12/14/2017 |
ISP Safety Huber Needle Infusion Set |
Infusion Safety Products, Inc. |
Alan P. Reid |
| K173126 |
12/05/2017 |
ArisstosÖ Spinal System |
Ingenium Spine |
David Brumfield |
| K172302 |
12/08/2017 |
InMode PLUS System |
InMode MD Ltd. |
Amit Goren |
| K172468 |
12/06/2017 |
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm |
InNeuroCo, Inc |
Marc Litzenberg |
| K170993 |
12/22/2017 |
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
Inova Diagnostics, Inc. |
Roger Albesa |
| K171773 |
12/01/2017 |
Straumann n!ce Glass Ceramic A14 Blocks |
Institut Straumann AG |
Shokoufeh Khodabandeh |
| K173403 |
12/29/2017 |
GEM Premier 5000 |
Instrumentation Laboratory Co. |
Carol Marble |
| K170029 |
12/15/2017 |
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile |
INTERNATIONAL BIOPHYSICS CORPORATION |
Geoff Marcek |
| K171102 |
12/21/2017 |
Ives MR Conditional Cup Electrode |
Ives EGG Solutions |
John Ives |
| K171012 |
12/19/2017 |
Veraview X800 |
J.Morita USA, Inc. |
Keisuke Mori |
| K172008 |
12/01/2017 |
ARIX Humerus System |
Jeil Medical Corporation |
Sejin Ryu |
| K170846 |
12/13/2017 |
Disposable Insulin Pen Needle |
Jiangsu Caina Technology Co., Ltd. |
Jun Lu |
| K172989 |
12/20/2017 |
Electric Breast Pump |
Joytech Healthcare Co., Ltd. |
Ren Yunhua |
| K173434 |
12/14/2017 |
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 |
JVC KENWOOD Corporation |
Masafumi Yugami |
| K172009 |
12/14/2017 |
Cascadia Interbody System |
K2M, Inc. |
Nancy Giezen |
| K172918 |
12/18/2017 |
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) |
KaVo Dental Technologies, LLC |
Frank Ray |
| K171748 |
12/14/2017 |
Vitrification Kit and Thawing Kit |
Kitazato Corporation |
Futoshi Inoue |
| K173696 |
12/19/2017 |
TBL-ABI System |
LD Technology LLC |
Albert Maarek |
| K173286 |
12/14/2017 |
Cannulated Screw Internal Fixation System |
Life Spine Inc. |
Randy Lewis |
| K172973 |
12/21/2017 |
Life Spine Foot and Ankle Plating System |
Life Spine Inc. |
Randy Lewis |
| K173182 |
12/20/2017 |
ProLift« Expandable System |
Life Spine Inc. |
Randy Lewis |
| K170046 |
12/07/2017 |
Lilium a-200E |
Lilium Otsuka Co., Ltd. |
Hiroaki Takahashi |
| K173484 |
12/11/2017 |
CorticaLINK Spinal Fusion Platform |
LinkSPINE Inc |
Nickolas Kriska |
| K173307 |
12/19/2017 |
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K172737 |
12/12/2017 |
MESIRE - Balloon Sinus Dilatation System |
M/s. Meril Life Sciences Private Limited |
Umesh Sharma |
| K172844 |
12/15/2017 |
Cellvizio 100 Series System with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K171928 |
12/08/2017 |
Med-Hot Thermal Imaging Systems |
Med-Hot Thermal Imaging Inc. |
Carol Chandler |
| K173267 |
12/07/2017 |
MasterLoc Stem: Lateralized Plus |
Medacta International SA |
Stefano Baj |
| K171058 |
12/13/2017 |
Medacta Shoulder System: Threaded Glenoid Baseplate |
Medacta International SA |
Stefano Baj |
| K171483 |
12/15/2017 |
ArchFlo CT Midline |
Medcomp (dba Medical Components, Inc.) |
Courtney Nix |
| K170497 |
12/15/2017 |
V10 |
Mediana Co., Ltd. |
Kim Min-hye |
| K170934 |
12/06/2017 |
C3 Wave System |
Medical Components, Inc (Dba Medcomp_ |
Courtney Nix |
| K172677 |
12/19/2017 |
Advantage Plus Pass-Thru |
Medivators Inc. |
Megan Skaar |
| K173664 |
12/29/2017 |
Medtronic O-arm O2 Imaging System |
Medtronic Inc. |
Dean Honkonen |
| K173125 |
12/20/2017 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek |
Kanesha Hines |
| K171866 |
12/20/2017 |
Sentrant Introducer Sheath with Hydrophilic Coating |
Medtronic Vascular, Inc. |
Wee Wen Leow |
| K171109 |
12/21/2017 |
Praxiject 0.9% NaCl |
MedXL Inc. |
Premala Premanathan |
| K170389 |
12/14/2017 |
TAURUS PEEK Cage System |
Medyssey USA, Inc. |
Shawn Kim |
| K172756 |
12/08/2017 |
Varian cage |
Medyssey USA, Inc. |
Shawn Kim |
| K173475 |
12/08/2017 |
Merge PACS |
Merge Healthcare Incorporated |
Carol Nakagawa |
| K173621 |
12/13/2017 |
Advocate PTA Catheter |
Merit Medical Systems Inc. |
Mark Mullaney |
| K173124 |
12/18/2017 |
PEEK Biosolution |
Merz Dental GmbH |
Claudia Bobrowski |
| K172848 |
12/27/2017 |
MEVION S250i Proton Beam Radiation Therapy Device |
Mevion Medical Systems |
Thomas H. Faris |
| K172786 |
12/08/2017 |
MDS Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K172448 |
12/21/2017 |
Riptide Aspiration System |
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
Ryan Kenney |
| K173420 |
12/27/2017 |
Radiomics App v1.0 |
Microsoft Corp. |
Ivan Tarapov |
| K172505 |
12/28/2017 |
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments |
MIS Implants Technologies Ltd. |
Arbel Shezaf |
| K170165 |
12/29/2017 |
Osteo-P Bone Graft Substitute |
Molecular Matrix, Inc. |
Charles Lee |
| K173492 |
12/22/2017 |
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software |
MolecularMD Corporation |
Kevin Hawkins |
| K173392 |
12/12/2017 |
Pure-Vu System |
Motus GI Medical Technologies Ltd. |
Hagit Ephrath |
| K173043 |
12/14/2017 |
Holycon Synthetic Absorbable Sutures |
Nantong Holycon Medical Devices Co., Ltd. |
Feng Lu |
| K172743 |
12/19/2017 |
Natus VikingQuest |
Natus Neurology Incorporated |
Shane T. Sawall |
| K173087 |
12/28/2017 |
UroLift System (UL400 and UL500) |
NeoTract, Inc. |
Louis-Pierre Marcoux |
| K171198 |
12/07/2017 |
NeuViz 16 Essence Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Shao Xiancheng |
| K172854 |
12/14/2017 |
NobelPerfect Abutments |
Nobel Biocare AB |
Charlemagne Chua |
| K173129 |
12/01/2017 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K173117 |
12/07/2017 |
NuVasive« VersaTieÖ System |
NuVasive, Inc. |
Marysa Loustalot |
| K172623 |
12/21/2017 |
NuVasive Navigation Instruments |
NuVasive, Incorporated |
Manthan J. Damani |
| K172676 |
12/14/2017 |
NuVasive« Modulus-C Interbody System |
NuVasive, Incorporated |
Marysa E. Loustalot |
| K173153 |
12/06/2017 |
Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System |
NuVasive, Incorporated |
Michelle Cheung |
| K173091 |
12/06/2017 |
Boundary Anterior Lumbar Buttress Plate |
Nvision Biomedical Technologies, LLC |
Diana L. Langham |
| K172734 |
12/07/2017 |
Single Use Electrosurgical Snare SD-400 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172618 |
12/05/2017 |
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K172467 |
12/21/2017 |
OMNI ARC Anteverted Neck Hip Stem |
OMNIlife science |
Christina Rovaldi |
| K171167 |
12/13/2017 |
Prodigio Stain Powder |
OperArt LLC |
Domenico Cascione |
| K173458 |
12/07/2017 |
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
Orthofix Srl |
Gianluca Ricadona |
| K172425 |
12/06/2017 |
OrthoPediatrics Wrist Fusion Plate |
OrthoPediatrics, Inc. |
Adam Cargill |
| K172573 |
12/15/2017 |
ReBOSSIS85 |
Orthorebirth Co., Ltd. |
Yasutoshi Nishikawa |
| K171269 |
12/28/2017 |
X-PSI Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Guylaine Roy |
| K170972 |
12/20/2017 |
Apex Tibial Nailing System |
OrthoXel |
Aisling O'Sullivan |
| DEN160014 |
12/22/2017 |
remOVE System |
OVESCO ENDOSCOPY AG |
Med.Marc O. Schurr |
| K173646 |
12/19/2017 |
FS Ergo |
PaloDEx Group Oy |
Anni Lundholm |
| K172886 |
12/20/2017 |
Breakaway Screw System |
Paragon 28 |
Eric Lintula |
| K173467 |
12/12/2017 |
Advanced Diffusion Analysis (ADA) application |
Philips Medical Systems Nederland B.V. |
Yoram Levy |
| K172904 |
12/26/2017 |
IntelliVue Capnography Extension, IntelliVue Microstream Extension |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K172349 |
12/14/2017 |
InFill« Interbody Fusion Device |
Pinnacle Spine Group, LLC |
Zach Sowell |
| K163328 |
12/28/2017 |
Planmed Clarity |
Planmed Oy |
Lars Moring |
| K173130 |
12/19/2017 |
Reform« Midline Cortical Screw System |
Precision Spine, Inc. |
Michael C. Dawson |
| K172893 |
12/21/2017 |
SafeSept Needle Free Transseptal Guidewire |
Pressure Products Medical Device Manufacturing LLC |
Andrew Armour |
| DEN170024 |
12/21/2017 |
AQUABEAM System |
PROCEPT BioRobotics Corporation |
Michael Nketiah |
| K172056 |
12/13/2017 |
InnoSight Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K173002 |
12/13/2017 |
2940 nm Er:Yag Laser Handpiece |
Quanta System S.p.A. |
Francesco DellÆAntonio |
| K171976 |
12/21/2017 |
Sofia Strep A+ FIA, Sofia 2 Analyzer |
Quidel Corporation |
Edward C. Brehm |
| K173250 |
12/21/2017 |
Solana GBS Assay |
Quidel Corporation |
Ronald H. Lollar |
| K171352 |
12/01/2017 |
EZFluence |
Radformation, Inc. |
Kurt Sysock |
| K173662 |
12/20/2017 |
speX Support Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K173102 |
12/29/2017 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K172503 |
12/01/2017 |
MR Conditional Cup Electrode, MR Conditional Webb Electrode |
Rhythmlink International, LLC |
Daniel McCoy |
| K170960 |
12/25/2017 |
CoaguChek Vantus System |
Roche Diagnostics |
Justin Davis |
| K170392 |
12/01/2017 |
S.I.N. Implant System |
S.I.N. û Sistema de Implante Nacional S.A. |
Denis Oliveira |
| DEN160037 |
12/28/2017 |
dermaPACE System |
SANUWAVE, INC. |
PETER STEGAGNO |
| K173260 |
12/04/2017 |
SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e╖POD System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172926 |
12/21/2017 |
SeaSpine Vu cPOD, Zuma-C, Complete Cervical |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173000 |
12/07/2017 |
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K173462 |
12/08/2017 |
Wireless Pain Relieve Device Model: LT5018C |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K173369 |
12/13/2017 |
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Jean Lei |
| K171381 |
12/13/2017 |
Adhesive Electrodes |
ShenZhen Quality Medical Technology Co.,Ltd |
Grace Zhao |
| K172222 |
12/08/2017 |
8ch Flex Suite |
Shenzhen RF Tech Co., Ltd. |
Ke Xi |
| K172530 |
12/06/2017 |
BEAUTIFIL Flow Plus X |
Shofu Dental Corporation |
Mauro Malzyner |
| K172286 |
12/18/2017 |
Automated Blood Coagulation Analyzer CS-2500 |
Siemens Healthcare Diagnostic Products Gmbh |
Nils Neumann |
| K171771 |
12/04/2017 |
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K173618 |
12/19/2017 |
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K173578 |
12/20/2017 |
Biograph mCT Family of PET/CT Systems |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K173600 |
12/19/2017 |
MAGNETOM Amira |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K173332 |
12/21/2017 |
OMNI Surgical System |
Sight Sciences, Inc. |
Anne-Marie Ripley |
| K171434 |
12/21/2017 |
ROCCIA« MultiLIF |
Silony Medical GmbH |
Bircan Yilmaz |
| K172688 |
12/22/2017 |
Align Radial Head System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K172876 |
12/04/2017 |
PowerDot PD-01M |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K172785 |
12/22/2017 |
CONQUEST FN |
Smith & Nephew |
Allison Chan |
| K170720 |
12/07/2017 |
Portex Blue Line Ultra Paediatric Tracheosomy Tube |
Smiths Medical ASD, Inc. |
James Taufen |
| K170862 |
12/19/2017 |
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope |
Solace Therapeutics, Inc. |
Scott Blood |
| K171935 |
12/01/2017 |
Alevicyn SG Antimicrobial Gel |
Sonoma Pharmaceuticals, Inc. |
Brian W. Martin |
| K173058 |
12/01/2017 |
P10 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K172993 |
12/05/2017 |
P20 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K170790 |
12/13/2017 |
SAM CRRT Unit, SAM Cassette CRRT |
Spectral Medical Inc. |
Danijela Domljanovic |
| K172594 |
12/15/2017 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K172474 |
12/29/2017 |
Celerity 20 HP Biological Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K172350 |
12/15/2017 |
AxSOS 3 Ti |
Stryker GmbH |
Kemine Hale |
| K170913 |
12/15/2017 |
Composite Removable Sinus Stent System |
STS Medical |
Lena Shlossberg |
| K172982 |
12/19/2017 |
SuperGrow 272, Ultimate 272 |
Super Grow Lasers |
Jeff Stanifer |
| K172978 |
12/22/2017 |
SurgeoBite |
Surgovations LLC |
Chris Menard |
| K172666 |
12/01/2017 |
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor |
SutureEase, Inc. |
Scott Heneveld |
| K171889 |
12/19/2017 |
Reusable Blood Pressure Cuff |
Suzhou Minhua Medical Apparatus Supplies Co., LTD |
Yang Qidong |
| K172560 |
12/21/2017 |
PREMIUM ONE Implant Systems |
Sweden & Martina S.p.A |
Alessia Pezzato |
| K172473 |
12/15/2017 |
LifeStyles« SKYN« Intimate Moments Personal Lubricant |
SXWELL USA LLC |
Robert Mahler |
| K170818 |
12/07/2017 |
Craniomaxillofacial Distraction System (CMFD) |
Synthes USA Products, LLC |
Nicholas Fountoulakis |
| K173536 |
12/12/2017 |
T2Candida 1.1 Panel |
T2 Biosystems, Inc. |
Anne Marie Whalen |
| K172692 |
12/13/2017 |
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens |
Tangible Science LLC |
Vic McCray |
| K172645 |
12/26/2017 |
iLux Instrument, iLux Disposable |
Tear Film Innovations, Inc. |
John Slate |
| K173441 |
12/13/2017 |
Neurosoft TMS (also CloudTMS) |
TeleEMG, LLC |
Joe F. Jabre |
| K173209 |
12/01/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K172863 |
12/14/2017 |
Infinix-i, INFX-8000V, V7.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172276 |
12/12/2017 |
Xario 200 Diagnostic Ultrasound System V6.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K173349 |
12/20/2017 |
Operio |
Toul Meditech AB |
Tomas Hansson |
| K172405 |
12/11/2017 |
SNIPER STAPLE SYSTEM, NON-STERILE |
Trilliant Surgical |
Jon Olson |
| K172257 |
12/22/2017 |
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) |
True Diagnostics, Inc |
Jerry Lee |
| K172185 |
12/21/2017 |
Tyber Medical PT Interbody Spacer System |
Tyber Medical LLC |
Mark F. Schenk |
| K173524 |
12/13/2017 |
ANAX 5.5Ö Spinal System |
U&I Corporation |
Jee Ae Bang |
| K172419 |
12/04/2017 |
VelofixÖ TLIF Cage |
U&i Corporation |
Jee-Ae Bang |
| K170279 |
12/12/2017 |
Disposable High Pressure Syringe |
Union Medical Shenzhen Co., Ltd. |
Wenguo Zhang |
| K163607 |
12/15/2017 |
ECG Acquisition Systems |
VALES & HILLS BIOMEDICAL TECH. LTD. |
Jianfang Liu |
| K173266 |
12/01/2017 |
Octane aspiration system |
Vascular Solutions Inc. |
Becky Astrup |
| K173532 |
12/15/2017 |
Raider Guidewire |
Vascular Solutions, Inc. |
Beka Vite |
| K170950 |
12/20/2017 |
Well-Root ST |
Vericom Co., Ltd. |
Hyoshin Chung |
| K171447 |
12/05/2017 |
OxyPure Color Silicone Hydrogel Soft Contact Lenses |
Visco Vision Inc |
Evan Huang |
| K171553 |
12/08/2017 |
W&H Assistina Twin |
W & H Dentalwerk Buermoos GmbH |
Mag. Anja Lindner |
| K170797 |
12/06/2017 |
wettrust D2care |
Wettrust Korea Co., Ltd. |
Sungho Lee |
| K172578 |
12/07/2017 |
Equipment Pouch |
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K171611 |
12/15/2017 |
Double Lumen Ovum Aspiration Needles |
William A. Cook Australia Pty Ltd |
Gordana Pozvek |
| K171513 |
12/07/2017 |
Lunderquist Extra Stiff Wire Guide |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K171573 |
12/29/2017 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K173013 |
12/14/2017 |
WishBone K-Wire System |
WishBone Medical, Inc. |
Gary Barnett |
| K172706 |
12/22/2017 |
GammaPod - Model A |
Xcision Medical Systems, LLC |
Daniel R. Plonski |
| K171858 |
12/18/2017 |
Sidus Stem-Free Shoulder |
Zimmer GmbH |
Roberto Tommasini |
