| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K172294 |
07/31/2017 |
Osteotomy Truss System (OTS) |
4Web, Inc. |
Jessee Hunt |
| K172073 |
07/10/2017 |
Hi-Torque Command 18 Guide Wire |
Abbott Vascular |
Kathyrene Logrono |
| K172216 |
07/24/2017 |
ACIST RXi Mini System |
ACIST Medical Systems, Inc. |
Amber Luker |
| K172027 |
07/05/2017 |
Adani MammoScan |
ADANI |
Vladimir Klokov |
| K172055 |
07/06/2017 |
DUS-7000 Digital Color Doppler Ultrasound System |
Advanced Instrumentations, Inc |
Jorge Millan |
| K172032 |
07/05/2017 |
Modulift Vertebral Body Replacement (VBR) System |
Aesculap Implants Systems, Inc. |
Lisa Boyle |
| K172235 |
07/25/2017 |
CoreHip« System |
Aesculap Implants Systems, LLC |
Paul Amudala |
| K172066 |
07/07/2017 |
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K172006 |
07/03/2017 |
Alivio Ventricular Catheter and Flusher System (Alivio System) |
Alcyone Lifesciences. Inc. |
PJ Anand |
| K172193 |
07/21/2017 |
Modified Alma Lasers Soprano XLÖ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules |
Alma Lasers Inc. |
Rekha Anand |
| K172042 |
07/06/2017 |
NeuroNav System, NeuroSmart System |
Alpha Omega Engineering Ltd. |
Maysana Mousa |
| K172253 |
07/26/2017 |
Altus Spine Cervical Interbody Fusion System |
Altus Partners, LLC |
Mark Melton |
| K172002 |
07/03/2017 |
Catalys Precision Laser System |
AMO Manufacturing USA, LLC |
Anita Xavier |
| K172232 |
07/25/2017 |
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 |
AMS Diagnostics |
Samuel Burgos |
| K172058 |
07/06/2017 |
CT6485, CT12885 |
Analogic Corporation |
Karen Provencher |
| K172067 |
07/07/2017 |
One Mum Pumpset |
Ardo medical AG |
Roger Dubach |
| K172033 |
07/05/2017 |
Pirouette High Pressure (HP) |
ArraVasc Ltd |
Carmel Doherty |
| K172052 |
07/06/2017 |
Arthrex DynaNite Nitinol Staple |
Arthrex Inc. |
Rebecca R. Homan |
| K172165 |
07/18/2017 |
Q-Fix Suture Anchor |
ArthroCare Corporation |
Laura Kasperowicz |
| K172228 |
07/25/2017 |
pioli IOL Delivery System |
AST Products, Inc. |
William Lee |
| K172166 |
07/18/2017 |
OLYMPIC Navigated Instruments |
Astura Medical |
Troy Taylor |
| K172029 |
07/05/2017 |
EnsoETM |
Attune Medical |
Erik Kulstad |
| K172236 |
07/25/2017 |
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled |
Avinger, Inc. |
Thomas Lawson |
| K172133 |
07/14/2017 |
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay |
Axis-Shield Diagnostics Ltd. |
Claire Dora |
| K172255 |
07/26/2017 |
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) |
Beckman Coulter, Inc |
Shannon Popson |
| K172204 |
07/21/2017 |
BD Intima II PLUS Closed IV Catheter System |
Becton, Dickinson and Company |
Henry Boland |
| K172280 |
07/28/2017 |
BH Sterilization Pouch |
BH Medical Products Co., Ltd. |
Edward Tao |
| K171985 |
07/03/2017 |
Astroglide O Oil Personal Lubricant & Massage Oil |
BioFilm Inc. |
Richard Hines |
| K172150 |
07/17/2017 |
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) |
bioMerieux, Inc |
Cherece L. Jones |
| K172060 |
07/07/2017 |
Capio SLIM Suture Capturing Device |
Boston Scientific Corporation |
Rachel Nankervis |
| K172209 |
07/24/2017 |
AURA ICP MONITORING SYSTEM |
Branchpoint Technologies, INC. |
Nicholas Hu |
| K172035 |
07/05/2017 |
EKOS ultrasound EVD Device, EVD Control Unit |
BTG International, Inc. |
Brit Baird |
| K172247 |
07/26/2017 |
Magic3 Go Intermittent Urinary Catheter |
C.R. Bard, Inc. |
Nancy Underwood |
| K172064 |
07/07/2017 |
Ti-Diagon Oblique TLIF |
Camber Spine Technologies |
Daniel Pontecorvo |
| K171986 |
07/03/2017 |
Sterling Supreme Diode Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K172227 |
07/25/2017 |
Endoscopic Injection Needle |
Carbon Medical Technologies, Inc. |
Andrew J. Adams |
| K172015 |
07/03/2017 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) |
Careglove Global Sdn Bhd |
Lim Kwee Shyan |
| K172186 |
07/20/2017 |
BioWick X Implant with Driver |
Cayenne Medical, Inc. |
Shima Hashemian |
| K172091 |
07/11/2017 |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, |
Centers for Disease Control and Prevention |
Yon Yu |
| K172126 |
07/14/2017 |
Xpert Xpress Strep A |
Cepheid |
Yi-Ping Lin |
| K172179 |
07/19/2017 |
Chitogel Endoscopic Sinus Surgery Kit |
Chitogel Ltd |
Caty Spencer |
| K172273 |
07/28/2017 |
308nm Excimer System |
Chongqing Peninsula Medical Technology Co., Ltd. |
Zhang Sudi |
| K172151 |
07/17/2017 |
Hysteroscopy System |
Chongquin Jinshan Science & Technology (Group) Co., Ltd. |
Qing Xu |
| K172083 |
07/10/2017 |
IdysÖ ALIF System |
CLARIANCE SAS |
Pascal Rokegem |
| K172022 |
07/05/2017 |
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) |
Codman & Shurtleff, Inc. |
Christopher Garete |
| K172258 |
07/26/2017 |
Novasight Hybrid System |
Conavi Medical Inc. |
Sam Mostafavi |
| K172017 |
07/03/2017 |
Black Silicone Filiform Double Pigtail Stent Set |
Cook Incorporated |
Karthik Pillai |
| K172278 |
07/28/2017 |
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent |
Cook Incorporated |
Samuel Engelman |
| K172217 |
07/24/2017 |
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath |
Cook Incorporated |
Andrew Breidenbach |
| K172051 |
07/06/2017 |
GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K171997 |
07/03/2017 |
Mandril Wire Guide |
Cook Incorporated |
Jennifer Allman |
| K171988 |
07/03/2017 |
Performer Guiding Sheath |
Cook Incorporated |
Reuben G. Lidster |
| K171999 |
07/03/2017 |
Performer Introducer |
Cook Incorporated |
Jennifer Allman |
| K171994 |
07/03/2017 |
Silicone Peripherally Inserted Central Venous Catheter Set/Tray |
Cook Incorporated |
Johnathan Liu |
| K172044 |
07/06/2017 |
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action |
Cook Ireland Ltd |
Laura Graham |
| K172057 |
07/06/2017 |
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set |
Cook Ireland Ltd. |
Orla Gunning |
| K172206 |
07/21/2017 |
NAJAÖ Ligament Correction System |
Cousin Biotech S.A.S. |
Mathilde Collet |
| K172128 |
07/14/2017 |
EsoFLIP« ES-310 Balloon Catheter |
Crospon Ltd. |
John OÆDea |
| K172049 |
07/06/2017 |
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED |
Cry IQ AB |
Stefan Skafte |
| K172085 |
07/11/2017 |
PhotoFix Decellularized Bovine Pericardium |
CryoLife, Inc. |
Heather Emerick |
| K172041 |
07/06/2017 |
truFreeze System |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K172212 |
07/24/2017 |
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEKÖ |
CTL Medical Corporation |
Tosan Onosode |
| K172077 |
07/10/2017 |
Cutera enlighten III Laser System |
Cutera, Inc. |
Bradley Renton |
| K172004 |
07/03/2017 |
truSculpt |
Cutera, Inc. |
Bradley Renton |
| K171992 |
07/03/2017 |
SculpSure |
Cynosure, Inc |
Amy Tannenbaum |
| K172305 |
07/31/2017 |
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump |
Datascope Corp. |
Helder A. Sousa |
| K172045 |
07/06/2017 |
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 |
| K172256 |
07/26/2017 |
SoftVue |
Delphinus Medical Technologies |
Francis X. Dobscha |
| K172225 |
07/25/2017 |
Atlantis Abutment for MIS Implant |
Dentsply Sirona |
Karl Nittinger |
| K172239 |
07/26/2017 |
SIMPLANT 18 |
Dentsply Sirona |
Karl Nittinger |
| K172030 |
07/05/2017 |
Devon 51 |
Devon Medical Products (Jiangsu) Ltd. |
Julian Chu |
| K172084 |
07/10/2017 |
Delta III Lithotripter |
Dornier MedTech America, Inc. |
John Hoffer |
| K172154 |
07/17/2017 |
Isolette 8000 plus |
Draeger Medical Sytems, Inc. |
Gale Winarsky |
| K172284 |
07/28/2017 |
NAPA LP-15 Airway Pressure Monitor |
DRW Medical, LLC |
Dan Tatum |
| K172007 |
07/03/2017 |
CamX Triton HD Proxi Head |
Duerr Dental AG |
Oliver Lange |
| K172266 |
07/27/2017 |
Dynarex Three-Way Stopcock |
Dynarex Corporation |
Pablo Martinez |
| K172142 |
07/17/2017 |
FibroScan 430 Mini+ |
Echosens |
Karine Bonenfant |
| K172196 |
07/21/2017 |
ECOMÖ Cardiac Output Monitoring System |
ECOM Medical, Inc |
Guy Lowery |
| K172285 |
07/28/2017 |
Ablatherm Fusion |
EDAP TECHNOMED, INC. |
Hugo Embert |
| K171996 |
07/03/2017 |
TruWave Disposable Pressure Transducer |
Edwards Lifesciences, LLC |
Renate A. MacLaren |
| K172173 |
07/19/2017 |
DiaSpect Tm, DiaSpect Tm Cuvettes |
EKF-diagnostic GmbH |
Mick Fenton |
| K172181 |
07/19/2017 |
micro IPL |
EL Global Trade Ltd |
Yael Liebes |
| K172270 |
07/28/2017 |
gammaCore-2 |
eletroCore, LLC |
Mike Romaniw |
| K171991 |
07/03/2017 |
EMPOWR Porous Knee System |
Encore Medical, L.P. |
Desiree Wells |
| K172089 |
07/11/2017 |
PROLENE Soft Polypropylene Mesh |
Ethicon, Inc. |
Stephanie Saati |
| K172244 |
07/26/2017 |
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
Daniel Castellanos |
| K172252 |
07/26/2017 |
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
Daniel Castellanos |
| K172205 |
07/21/2017 |
ExoToe Staple |
ExoToe LLC |
Avi Roop |
| K172260 |
07/27/2017 |
Omni Foot Plating System |
Extremity Medical, LLC. |
Brian Smekal |
| K172238 |
07/26/2017 |
CAREline Airless Hemodialysis Blood Tubing Sets |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K172121 |
07/13/2017 |
Digital Thermometer |
Fudakang Industrial Co., Ltd |
Bob Yu |
| K172214 |
07/24/2017 |
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters |
G-21 s.r.l. |
Maurizio Foroni |
| K172028 |
07/05/2017 |
GebauerÆs Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) |
Gebauer Company |
Brittney Schmies |
| K172010 |
07/03/2017 |
gel-e Bandage |
gel-e, Inc. (formerly Remedium Technologies, Inc.) |
Matthew Dowling |
| K172180 |
07/19/2017 |
OSCAR 15 |
Genoray Co.,Ltd |
Ji-Yeon Choi |
| K172103 |
07/12/2017 |
Flowtron DVT5 Small Calf Garment |
Getinge (Suzhou) Co., Ltd. |
Daisy Qin |
| K172269 |
07/28/2017 |
FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System |
Globus Medical, Inc. |
Kelly J. Baker |
| K172168 |
07/18/2017 |
WillCeph |
HDX WILL CORP. |
Myoung-Joon Lee |
| K172110 |
07/13/2017 |
ECHELON OVAL V6.0A MRI System |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K172087 |
07/11/2017 |
SANGRAY |
Hitachi Ltd. |
Kazuaki Tsuchiya |
| K172011 |
07/03/2017 |
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
HMicro, Inc. |
Kim Tompkins |
| K172282 |
07/28/2017 |
Panther Fusion Paraflu Assay |
Hologic, Inc. |
Jeffrey Hergesheimer |
| K172306 |
07/31/2017 |
SuperSlyde Personal Lubricant |
ICM Pharma Pte Ltd |
Dennis Fortich |
| K172096 |
07/11/2017 |
Fraxis |
Ilooda Co. LTD |
Kathy Maynor |
| K172078 |
07/10/2017 |
ImmuLisa Enhanced RNA POL III Antibody ELISA |
IMMCO Diagnostics, Inc. |
Kevin Lawson |
| K172122 |
07/13/2017 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K172300 |
07/31/2017 |
CoLink View Plating System |
In2Bones USA, LLC |
Rebecca Wahl |
| K172302 |
07/31/2017 |
InMode PLUS System |
InMode MD Ltd. |
Amit Goren |
| K172167 |
07/18/2017 |
Zenith Flex System |
InNeuroCo, Inc. |
Marc Litzenberg |
| K172200 |
07/21/2017 |
3880 MRI Patient Monitoring System |
Iradimed Corporation |
Francis Casey |
| K172008 |
07/03/2017 |
ARIX Humerus System |
Jeil Medical Corporation |
Sejin Ryu |
| K172104 |
07/12/2017 |
Ozark(tm) Cervical Plate System |
K2M Inc. |
Nancy Giezen |
| K172009 |
07/03/2017 |
Cascadia Interbody System |
K2M, Inc. |
Nancy Giezen |
| K172086 |
07/11/2017 |
MatiraÖ Anterior Cervical System |
Kalitec Direct, LLC |
Keith Cannan |
| K172264 |
07/27/2017 |
OTW Takeru PTCA Balloon Dilatation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
| K172118 |
07/13/2017 |
U by Kotex Click Unscented Menstrual Tampons |
Kimberly-Clark Corporation |
Charnelle Thomas |
| K172039 |
07/05/2017 |
CATHTONG II PICC Catheter |
L&Z US, Inc. |
Jenella Coutts |
| K172099 |
07/11/2017 |
Shoocin Introducer Kit |
Lepu Medical Technology (Beijing) Co., Ltd. |
Xiangdan Jin |
| K172131 |
07/14/2017 |
2 Hole Lateral Plating System |
Life Spine Inc. |
Randy Lewis |
| K172105 |
07/12/2017 |
The Plateau-LO Spacer System |
Life Spine Inc. |
Randy Lewis |
| K172271 |
07/28/2017 |
Trackit T4 EEG Amplifier |
Lifelines Ltd. |
Michael Hulin |
| K172059 |
07/07/2017 |
LinkQuest Diagnostic Ultrasound System model SQ860 |
LinkQuest Inc. |
Xiaolong Yu |
| K172109 |
07/13/2017 |
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K171987 |
07/03/2017 |
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove |
Lucenxia Prescience AG |
Robert Hill |
| K172149 |
07/17/2017 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K172146 |
07/17/2017 |
MERISTEEL |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K172296 |
07/31/2017 |
Stethee Pro |
M3dicine Pty. Ltd. |
Nayyar Hussain |
| K172301 |
07/31/2017 |
Mako Partial Knee Application |
MAKO Surgical Corp. |
Andrea Dwyer Steiner |
| K172219 |
07/24/2017 |
Mako Total Knee Application |
MAKO Surgical Corp. |
Karen Ariemma |
| K172159 |
07/18/2017 |
Getinge GSS67N Series Steam Sterilizer |
Maquet GmbH |
Holger Ullrich |
| K172054 |
07/06/2017 |
Materialise Glenoid Positioning System |
Materialise NV |
Oliver Clemens |
| K172170 |
07/18/2017 |
APTUS(R) Wrist 2.5 System |
Medartis AG |
Andrea Schweizer |
| K172145 |
07/17/2017 |
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion û 120 days, Invia Motion û 60 days, Invia Motion û 30 days, Invia Motion û 15 days, Invia Motion û 7 days), Invia Liberty Negati |
Medela AG |
Georges Hakim |
| K172095 |
07/11/2017 |
Autokeeper |
MedExel Co.,Ltd. |
Cha Dong Ik |
| K172021 |
07/05/2017 |
LigaPASS |
Medicrea International S.A. |
David Ryan |
| K172036 |
07/05/2017 |
Medrobotics Flex Robotic System |
Medrobotics Corporation |
John D. Bonasera |
| K172062 |
07/07/2017 |
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray |
MedScience Science Research Group, Inc. |
Marvin Smollar |
| K172199 |
07/21/2017 |
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium |
Medtronic Sofamor Danek |
Justin O'Connor |
| K172277 |
07/28/2017 |
Phlebo Press DVT Model |
Mego Afek AC Ltd. |
Reuven Yunger |
| K172213 |
07/24/2017 |
MECRON Cannulated Screw System |
Merete GmbH |
Paul Munch |
| K172081 |
07/10/2017 |
Maestro Microcatheter |
Merit Medical Systems, Inc. |
Niloufar Samimi |
| K172117 |
07/13/2017 |
Prelude Pursuit Splittable Sheath Introducer |
Merit Medical Systems, Inc. |
Jacquelyn Huyghue |
| K172014 |
07/03/2017 |
Wedge Microcatheter |
Micro Vention, Inc. |
Chet Jones |
| K172309 |
07/31/2017 |
Endoscopic Ultrasound Aspiration Needle |
Micro-Tech (Nanjing) CO.,Ltd. |
Becky Li |
| K172218 |
07/24/2017 |
MIM û Y90 Dosimetry |
MIM Software Inc. |
Lynn Hanigan |
| K172240 |
07/26/2017 |
SPI Dental Implant System |
MSI France |
Gerard Bouna |
| K172208 |
07/24/2017 |
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet |
NeVap, Inc. |
Brenton Hanlon |
| K172297 |
07/31/2017 |
NovaCross Microcatheter |
Nitiloop Ltd. |
Chanan Schneider |
| K172224 |
07/25/2017 |
DTX Studio diagnose |
Nobel Biocare AB |
Charlemagne Chua |
| K172203 |
07/21/2017 |
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray |
Nuance Medical, LLC |
Marc Lieberman |
| K172061 |
07/07/2017 |
PRECICE UNYTE System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K172123 |
07/14/2017 |
NuVasive« Modulus XLIF Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K172298 |
07/31/2017 |
OLYMPUS URF-P6/P6R |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172246 |
07/26/2017 |
OLYMPUS URF-V2/V2R |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172079 |
07/10/2017 |
Avail |
Omron Healthcare, Inc. |
Renee Thornborough |
| K172197 |
07/21/2017 |
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS |
ORIGIO a/s |
Tove Kjaer |
| K172194 |
07/21/2017 |
Connector System |
Orthofix Inc. |
Jacki Koch |
| K172115 |
07/13/2017 |
Navigated Instrument System |
Orthofix Inc. |
Jacki Koch |
| K172183 |
07/19/2017 |
Guided Growth Plate System Plus |
Orthofix Srl |
Gianluca Ricadona |
| K172176 |
07/19/2017 |
Parkell Universal Adhesive |
Parkell, Inc. |
David Mott |
| K172156 |
07/18/2017 |
PENTAX Medical EPK-3000 Video Imaging System |
Pentax Medical |
William Goeller |
| K172226 |
07/25/2017 |
MX40 Release B.07 |
Philips Medical Systems |
Theresa Poole |
| K172307 |
07/31/2017 |
Dynamic Coronary Roadmap 2.0 |
Philips Medical Systems Nederland B.V. |
Laura Wortel |
| K172174 |
07/19/2017 |
Philips IntelliSite Pathology Solution |
Philips Medical Systems Nederland B.V. |
Esther Abels |
| K172139 |
07/17/2017 |
Streamline OCT Occipito-Cervico-Thoracic System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K172140 |
07/17/2017 |
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) |
PolyNovo Biomaterials Pty Ltd |
Sue Cho |
| K172132 |
07/14/2017 |
CleanCision Wound Retraction and Protection System |
Prescient Surgical, Inc. |
Lisa Claude |
| K172164 |
07/18/2017 |
PROPEL Device |
Propel Orthodontics LLC |
Bryce Way |
| K172279 |
07/28/2017 |
PMT Posterior Fixation System |
Providence Medical Technology, Inc. |
Edward Liou |
| K172169 |
07/18/2017 |
Pulpdent (Activa) Pit and Fissure Sealant with MCP |
Pulpdent Corporation |
Kenneth J. Berk |
| K172259 |
07/27/2017 |
PulsioFlex Monitoring System |
PULSION Medical Systems SE |
Marc Bergenthal |
| K172289 |
07/31/2017 |
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent |
Q Urological Corporation |
Scott Epstein |
| K172287 |
07/28/2017 |
ipsogen JAK2 RGQ PCR Kit |
QIAGEN, Inc. |
Lindsey Howard |
| K172056 |
07/06/2017 |
InnoSight Diagnostic Ultrasound System |
Qisda Corporation |
Johnson Sheu |
| K172198 |
07/21/2017 |
585 |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K172025 |
07/05/2017 |
Litho 60 |
quanta system spa |
Francesco Dell' Antonio |
| K172281 |
07/28/2017 |
PuRE PMMA Disc |
Quest Dental USA Corp. |
Hirotaka Mori |
| K172093 |
07/11/2017 |
Reprocessed Covidien Trocar |
Renovo, Inc. |
Mark K. Wells |
| K172097 |
07/11/2017 |
Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves |
Renovo, Inc. |
Mark K. Wells |
| K172092 |
07/11/2017 |
Reprocessed Shavers/Burs |
Renovo, Inc. |
Mark K. Wells |
| K172229 |
07/25/2017 |
GC85A |
Samsung Electronics Co.,Ltd. |
Jaesang NOH |
| K172129 |
07/14/2017 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
JiYeon Cho |
| K172137 |
07/17/2017 |
PIEZOTOME CUBE |
Satelec - Acteon Group |
Philippe Girard |
| K172292 |
07/31/2017 |
SALUS - Hygiene Instrument Reprocessing Container |
SciCan Ltd. |
Teresa Boyce |
| K172047 |
07/06/2017 |
Riva Star |
SDI Limited |
Ray Cahill |
| K172130 |
07/14/2017 |
Resorbable Mesh Device |
SeaSpine Orthopedics Corporation |
Jenny Fam |
| K172195 |
07/21/2017 |
HYDRASHIFT 2/4 daratumumab, daratumumab Control |
Sebia |
Karen Anderson |
| K172141 |
07/17/2017 |
Pulse Oximeter |
Shanghai Berry Electronic Tech Co., Ltd |
Xuezhi Yin |
| K172135 |
07/14/2017 |
uCT Computed Tomography X-ray System |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K172143 |
07/17/2017 |
uMI 780 PET/CT System |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172222 |
07/24/2017 |
8ch Flex Suite |
Shenzhen RF Tech Co., Ltd. |
Ke Xi |
| K172242 |
07/26/2017 |
DripAssist Plus |
Shift Labs, Inc. |
Beth Kolko |
| K172106 |
07/12/2017 |
SHOFU MZ Primer Plus |
Shofu Dental Corporation |
Mauro Malzyner |
| K172268 |
07/27/2017 |
iFuse Implant System- iFuse Navigation |
SI-BONE, Inc. |
Roxanne Dubois |
| K172162 |
07/18/2017 |
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems |
Siemens Healthcare |
Jessica Stenberg |
| K172286 |
07/28/2017 |
Automated Blood Coagulation Analyzer CS-2500 |
Siemens Healthcare Diagnostic Products Gmbh |
Nils Neumann |
| K172201 |
07/21/2017 |
Atellica IM Folate Assay |
Siemens Healthcare Diagnostics Inc. |
Darius Daruwala |
| K172020 |
07/05/2017 |
Arlington PLIF/TLIF Cage |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K172019 |
07/05/2017 |
Brisbane ALIF Device, Gladstone ALIF Device |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K172147 |
07/17/2017 |
STAR 65 |
Skanray Technologies Pvt Ltd |
Mahadevan J |
| K172005 |
07/03/2017 |
PICO 7 Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172262 |
07/27/2017 |
EVOS Small Fragment Plating System |
Smith & Nephew, Inc. |
Samantha Staubach |
| K172082 |
07/10/2017 |
S60 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K172160 |
07/18/2017 |
Southern Implants PEEK Abutments |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K172175 |
07/19/2017 |
CapSure« PS System |
Spine Wave, Inc. |
Amy Noccioli |
| K172101 |
07/12/2017 |
ROMEO« 2 Posterior Osteosynthesis System |
Spineart |
Franck Pennesi |
| K172065 |
07/07/2017 |
SCARLET AC-T |
SPINEART |
Franck PENNESI |
| K172107 |
07/12/2017 |
ThresholdÖ V2 Pedicular Fixation System, ThresholdÖ Pedicular Fixation System, FortressÖ Pedicular Fixation System, PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline A. Hauge |
| K172223 |
07/24/2017 |
SleepRight ProRx Custom Dental Guard |
Splintek, Inc. |
Samantha Schroeder |
| K172182 |
07/19/2017 |
QUANTIEN Measurement System |
St. Jude Medical (now part of the Abbott Medical) |
Julie Dalquist |
| K172207 |
07/21/2017 |
Standard Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
Bradley J. Bushman |
| K172012 |
07/03/2017 |
star RF Electrode, VIVA RF Electrode |
STARmed Co., Ltd. |
Jun-Young Jung |
| K172155 |
07/17/2017 |
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing |
StatGuard, LLC |
Gary Mills |
| K172116 |
07/13/2017 |
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) |
Stryker Corporation |
Kristi Ashton |
| K172034 |
07/05/2017 |
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap |
Stryker Corporation |
Andrea Wallen-Gerding |
| K172148 |
07/17/2017 |
Anchorage Bone Plating System |
Stryker GmbH |
Jackie Perri |
| K172210 |
07/24/2017 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker Trauma AG |
Tina Mornak |
| K172187 |
07/20/2017 |
Inno-Hydrowire |
Suzhou Innomed Medical Device Co.,Ltd |
Jimmy Li |
| K172068 |
07/07/2017 |
Kenz Cardico1211 |
Suzuken Co.,Ltd. |
Eiji Yamaguchi |
| K172157 |
07/18/2017 |
DePuy Synthes Femoral Recon Nail System |
Synthes (USA) Products, LLC |
Alexander Zwahlen |
| K172234 |
07/25/2017 |
Oxygen Concentrator |
SysMed (China) Co., Ltd |
Jian Yue |
| K172221 |
07/24/2017 |
VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 |
TaiDoc Technology Corporation |
Anne Kuo |
| K172016 |
07/03/2017 |
Force Fiber Fusion Suture |
Teleflex Medical Incorporated |
Vladislava Zaitseva |
| K172124 |
07/14/2017 |
Televere Podiatry Digital Imaging System |
Televere Systems |
Randell Quaal |
| K172220 |
07/24/2017 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Bryan K. Hann |
| K172071 |
07/10/2017 |
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) |
Terumo Cardiovascular Systems Corporation |
Garry A. Courtney |
| K172048 |
07/06/2017 |
FluidSmart |
THERMEDX, LLC |
Homer Gregory |
| K172274 |
07/28/2017 |
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8╡g/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K172299 |
07/31/2017 |
Accordion Piccolo Stone Management Device |
THS International, Inc. d/b/a Accordion Medical |
David Quigley |
| K172267 |
07/27/2017 |
IRENE Thoracolumbar Fixation System |
Tianjin Zhengtian Medical Instrument Co.,Ltd. |
Ou Changli |
| K172188 |
07/20/2017 |
Aquilion Prime SP, TSX-303B/1, v8.4 |
Toshiba Medical Systems Coroporation |
Paul Biggins |
| K172276 |
07/28/2017 |
Xario 200 Diagnostic Ultrasound System V6.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172178 |
07/19/2017 |
Minimally Invasive Bunion Plating System |
Trilliant Surgical, LTD |
Jonathan Olson |
| K172254 |
07/26/2017 |
Lyme B. burgdorferi (IgM) MarStripe Test |
Trinity Biotech |
Kevin Lawson |
| K172304 |
07/31/2017 |
TruAbutment DS |
TruAbutment Inc. |
Brandon Kim |
| K172100 |
07/11/2017 |
URIS OMNI System |
TruAbutment Inc. |
Brandon Kim |
| K172257 |
07/26/2017 |
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 |
| K172189 |
07/20/2017 |
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt |
Truemed Group LLC |
Nina Galeana Rodriguez |
| K172191 |
07/20/2017 |
STERIZONE VP4 Sterilizer |
TSO3 Inc |
Alexandre Jokic |
| K172185 |
07/20/2017 |
Tyber Medical PT Interbody Spacer System |
Tyber Medical LLC |
Mark F. Schenk |
| K172241 |
07/26/2017 |
Tyece OTC EMS System, Model EM35 |
Tyece Ltd. |
Parshid Falahati |
| K172251 |
07/26/2017 |
UTS Stem |
United Orthopedic Corporation |
Gimpel Chien |
| K172163 |
07/18/2017 |
Eclipse Treatment Planning System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172013 |
07/03/2017 |
VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172090 |
07/11/2017 |
GuideLiner V3 Catheter |
Vascular Solutions, Inc. |
Beka Vite |
| K172111 |
07/13/2017 |
Vevazz LED |
Vevazz, LLC |
Jamie Fettig |
| K172023 |
07/05/2017 |
CELFIRM |
VIOL Co., Ltd. |
Jongju Na |
| K172050 |
07/06/2017 |
Follicle Aspiration Set, Reduced Single Lumen |
Vitrolife Sweden AB |
Anja Bengtzelius |
| K172177 |
07/19/2017 |
Insulia Diabetes Management Companion |
Voluntis S.A. |
Kevin Howard |
| K172040 |
07/05/2017 |
Aquilex Fluid Control System AQL-100S |
W.O.M. World Of Medicine GmbH |
Lucia Puetmann |
| K172000 |
07/03/2017 |
ClearLumen II Peripheral Thrombectomy System |
Walk Vascular, LLC |
David Look |
| K172038 |
07/05/2017 |
Trocar |
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K172120 |
07/13/2017 |
Veress Needle |
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K171989 |
07/03/2017 |
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber R |
Wilson-Cook Medical Inc. |
Ashley Howard |
| K171993 |
07/03/2017 |
Zimmon Needle Knife Papillotome |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Doris A. Hawks |
| K172288 |
07/31/2017 |
Fusion OMNI Sphincterotome |
Wilson-Cook Medical, Inc./ Cook Endoscopy |
Sierra Lowe |
| K172237 |
07/25/2017 |
Bicera Resorbable Bone Substitute |
Wiltrom Corporation Limited |
Yi-Chun Su |
| K172080 |
07/10/2017 |
Photoelectric Therapy System |
Xstrahl Ltd. |
Andrew Mullen |
| K172144 |
07/17/2017 |
CoolSculpting System |
ZELTIQ Aesthetics |
Ewald Riechert |
| K172098 |
07/11/2017 |
Medical Video Endoscope System |
Zhuhai Pusen Medical Technology Co., Ltd. |
WANG CHANGSHEN |
| K172275 |
07/28/2017 |
Vitality« Spinal Fixation System, Vitality«+ Power Instrument System |
Zimmer Biomet Spine, Inc. |
Kelly Stratton |
| K172114 |
07/13/2017 |
Zimmer Natural Nail System |
Zimmer Inc. |
Dhaval Saraiya |
