FDA 510(k) Applications Received During July, 2017

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
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
K172171 07/18/2017 Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T Shenzhen Jamr Medical Technology CO., Limited Li Xue
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


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