FDA 510(k) Decisions During November, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K170754 11/21/2017 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 3M Company, 3M Health Care Maria Ruiz
K172392 11/07/2017 Lateral Spinal Truss System (LSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K171650 11/21/2017 Alere Afinion HbA1c and ACR on Afinion 2 analyzer Abbott Rapid Diagnostics Monica Vallestad
K172603 11/27/2017 Cerafix Dura Substitute Acera Surgical, Inc. Matthew MacEwan
K171254 11/16/2017 LeEject 2 Dental Syringe and Needle System Advanced Technology and Capital, Inc. Alexander Lee
K170634 11/29/2017 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 Advanced Vehicle Concepts Ltd. Mark Nicholls
K172032 11/20/2017 Modulift Vertebral Body Replacement (VBR) System Aesculap Implants Systems, Inc. Lisa Boyle
K173271 11/10/2017 Aesculap Slim Clip Applier Forceps Aesculap, Inc. Paul Amudala
K172850 11/17/2017 SterilContainer with PrimeLine Pro Lid Aesculap, Inc. Lisa Boyle
K172006 11/09/2017 Alivio Ventricular Catheter and Flusher System (Alivio System) Alcyone Lifesciences. Inc. PJ Anand
K171816 11/16/2017 Kardia Band System AliveCor, Inc Prabhu Raghavan
K173522 11/30/2017 Solanas« Posterior Stabilization System Alphatec Spine, Inc Natalia Shirina
K172253 11/21/2017 Altus Spine Cervical Interbody Fusion System Altus Partners, LLC Mark Melton
K170439 11/01/2017 AN87 Dosimeter Andersen Sterilizers, Inc. William K. Andersen
K170437 11/01/2017 Sterisheet Sterilization Wrap Andersen Sterilizers,Inc. William K. Andersen
K173016 11/15/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K171886 11/15/2017 OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery Inc Maritza Ward
K172759 11/14/2017 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K172067 11/29/2017 One Mum Pumpset Ardo medical AG Roger Dubach
K173319 11/16/2017 KaVo NOMAD Pro 2 Handheld X-ray System Aribex Erika Martin
K172318 11/17/2017 Endoform Silver Dermal Template Aroa Biosurgery Tina O'Brien
K171365 11/07/2017 Arthrex Knee Systems Arthrex Inc. David L. Rogers
K170206 11/15/2017 Arthrex FiberTape Cerclage ARTHREX, INC. IVETTE GALMEZ
K171482 11/16/2017 NEPHROCHECK Test System Astute Medical, Inc. Karin Hughes
K170595 11/07/2017 IV Administration Sets B. Braun Medical Inc. Nancy Skocypec
K170897 11/03/2017 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site B. Braun Medical Inc. Angela J. Caravella
K173089 11/27/2017 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions Bausch & Lomb Incorporated Melissa Thomas
K173365 11/17/2017 Bausch + Lomb Boston Scleral Lens Case Bausch & Lomb Incorporated Nancy Fehrman
K170524 11/13/2017 Access AMH Beckman Coulter, Inc. Debbie Kidder
K171026 11/01/2017 Mytens Model: BW-TSX Bewell Connect Corp. Jacob Chen
DEN170017 11/24/2017 FilmArray Respiratory Panel 2 plus (RP2plus) BioFire Diagnostics, LLC Kristen J. Kanack
K172576 11/22/2017 BioHorizons Tapered Short Implants BioHorizons Implant Systems, Inc. Michael Davis
K172771 11/29/2017 Epic Pro 940 Biolase, Inc Alicia Mszyca
K173372 11/24/2017 ExactechGPS Total Shoulder Application Blue Ortho Anthony Boyer
K172060 11/03/2017 Capio SLIM Suture Capturing Device Boston Scientific Corporation Rachel Nankervis
K172591 11/03/2017 Fixed Patient Leads ECG Cable (Model 3153) Boston Scientific Corporation Elizabeth A. Lisowski
K173284 11/16/2017 OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K172453 11/09/2017 WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation Lori Berends
K172446 11/07/2017 SPIRA-C Open Matrix Cervical Interbody Camber Spine Technologies Michael Black
K171270 11/17/2017 DIGITAL RADIOGRAPHY CXDI-410C WIRELESS Canon, Inc SHINJI MORI
K170405 11/02/2017 BD Curve Ascites Shunt CareFusion Tamara Brey
K172609 11/03/2017 CSMC Cardiac Suite Cedars-Sinai Medical Center Geoff Pollard
K173006 11/28/2017 Cefaly Dual CEFALY Technology Jean-Yves Mignolet
K170102 11/13/2017 Pekkton Ivory CENDRES+METAUX SA Uli DIERMANN
K172525 11/13/2017 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K172642 11/28/2017 Orange Non Sterile Powder Free Nitrile Examination Gloves Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K172538 11/30/2017 Disposable Linear Stapler, Disposable Linear Cutter Changzhou Kangdi Medical Stapler Co.,Ltd. Eve Zhou
K170983 11/22/2017 NIOX VERO Circassia AB Susanne Parks
K172083 11/08/2017 IdysÖ ALIF System CLARIANCE SAS Pascal Rokegem
K173192 11/08/2017 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit Codman & Shurtleff, Inc Megan Palumbo
K170422 11/02/2017 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K170362 11/15/2017 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K170856 11/17/2017 CMS600P2 B-Ultrasound Diagnostic System Contec Medical Systems Co., LTD. Xueyong Li
K172924 11/21/2017 GentleCath Intermittent Urinary Catheter ConvaTec Limited Hannah Sharp
K173289 11/15/2017 Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter Cook Incorporated David E. Chadwick
K170931 11/13/2017 CXI TriForce Peripheral Crossing Set Cook Incorporated Sarah Reeves
K172278 11/22/2017 Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent Cook Incorporated Samuel Engelman
K173355 11/17/2017 Gastric Sizing Balloon Catheter Cook Incorporated Colin Jacobs
K173009 11/07/2017 NCompass Nitinol Stone Extractors Cook Incorporated Colin Jacob
K173068 11/17/2017 Performer Introducer COOK Incorporated Reuben G. Lidster
K172757 11/02/2017 Valleylab FX8 Electrosurgical Platform Covidien llc Sharon McDermott
K172128 11/22/2017 EsoFLIP« ES-310 Balloon Catheter Crospon Ltd. John OÆDea
K172769 11/30/2017 CryOmega Flexx CryoConcepts LP R Sam Niedbala
K171473 11/07/2017 CompressynÖ Staple Dallen Medical, Inc. Al Memmolo
K172045 11/03/2017 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 Datex-Ohmeda, Inc. Trishia Mercier
K173018 11/20/2017 MDR17 Mobile Direct Radiographic System Del Medical, Inc. Tony Bavuso
K172398 11/22/2017 DENTCA DENTURE Teeth DENTCA, INC. Jason Lee
K171694 11/29/2017 s-Clean TiN Coating Abutments Dentis Co., Ltd. Sun Chul Shin
K172225 11/30/2017 Atlantis Abutment for MIS Implant Dentsply Sirona Karl Nittinger
K172030 11/27/2017 Devon 51 Devon Medical Products (Jiangsu) Ltd. Julian Chu
K170959 11/24/2017 DIXI Medical Microdeep Depth Electrode DIXI Medical Lucie Petegnief
K171004 11/07/2017 Hintermann Series H2 Total Ankle System Dt MedTech LLC Shawn T Huxel
K172007 11/22/2017 CamX Triton HD Proxi Head Duerr Dental AG Oliver Lange
DEN170041 11/29/2017 GeneSTAT.MDx Coccidioides Assay DxNA, LLC Ernie Sumsion
K173034 11/14/2017 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K173003 11/15/2017 U50 Diagnostic Ultrasound System Edan Instruments, Inc. Alice Yang
K172660 11/17/2017 Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC Christine Chun
K172738 11/08/2017 RadiForce RX560, RX560-AR EIZO Corporation Hiroaki Hashimoto
K172362 11/17/2017 DEKA SMARTXIDE TOUCH EL.EN Electronic Engineering Spa Paolo Peruzzi
K172363 11/17/2017 DEKA SMARTXIDE ULTRASPEED EL.EN. Electronic Engineering Spa Paolo Peruzzi
K172703 11/13/2017 Disposable Snap Electrode Embla Systems Sanjay Mehta
K171534 11/08/2017 SurgicalPreview Endo Vantage, LLC Robert S. Green
K173399 11/30/2017 Endophys Pressure Sensing Sheath Kit- 8F Endophys Holdings, LLC Phillip Purdy
K172441 11/06/2017 EPIC Extremity Fracture Plate System EPIC Extremity, LLC Dan Schwartzbauer
K172580 11/20/2017 ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Ethicon Endo-Surgery, LLC Carmen Ortiz
K170767 11/01/2017 Surgical Stainless Steel Suture, Stainless Steel Suture Ethicon, Inc. Hrishikesh Khatav
K172260 11/06/2017 Omni Foot Plating System Extremity Medical, LLC. Brian Smekal
K171467 11/09/2017 BioZorb Marker GOLD / LP Marker GOLD Focal Therapeutics George Hermann
K173037 11/21/2017 Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical Inc. Lynne Davies
K172695 11/22/2017 AIR Anterior Array, AIR Posterior Array GE Healthcare Coils (USA Instruments, Inc.) Mary A. Mayka
K172700 11/09/2017 OEC One GE HUALUN MEDICAL SYSTEMS CO., LTD. Lifeng Wang
K173341 11/02/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Tracey Ortiz
K171580 11/01/2017 Monitor B125, Monitor B105 GE MEDICAL SYSTEMS (CHINA) CO., LTD. Sun YanLi
K172550 11/16/2017 OEC Elite GE OEC Medical Systems, Inc. Rachel Schandel
K171050 11/09/2017 Geistlich Fibro-Gide Geistlich Pharma AG Marco Steiner
K171842 11/03/2017 Geistlich Wound Matrix Geistlich Pharma AG Jan van der Ploeg
K171736 11/15/2017 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K172569 11/22/2017 GenePOC CDiff GenePOC Inc. Guy Sevigny
K172469 11/30/2017 TiLock Modular Spinal System Genesys Spine Brian J. Bergeron
K170606 11/16/2017 Acrylic Herbst Appliance with Micro-Recorder Gergen's Orthodontic Lab Chris Morrison
K173166 11/13/2017 ANTHEM Fracture System Globus Medical Inc. Kelly J. Baker
K162315 11/09/2017 FORTIFY Corpectomy Spacers GLOBUS MEDICAL INC. Kelly J. Baker
K172712 11/06/2017 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler GRI Medical & Electronic Technology Co, Ltd Marty D. Paugh
K170229 11/08/2017 Dental High-speed Turbine Handpiece GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. KRISTI YANG
K170236 11/21/2017 Dental Low-speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd. Kristi Yang
K172442 11/06/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC SDN. BHD. Kuan Mun Leong
K172649 11/01/2017 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor Heidelberg Engineering GmbH Gerhard Zinser
K170664 11/09/2017 Odyssey Micro Catheter Heraeus Medical Components, LLC Margaret Batchelder
K171681 11/21/2017 Hermes Medical Imaging Suite v5.7 Hermes Medical Solutions AB Joakim Arwidson
K171719 11/21/2017 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K171803 11/29/2017 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Linda Lin
K170353 11/01/2017 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT HORIBA ABX SAS Caroline Ferrer
K172634 11/16/2017 Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components Howmedica Osteonics Corp aka Stryker Orthopaedics Shahrir Alam
K173099 11/30/2017 Fortis and Hana Anterior Cervical Plate System Huvexel Co., Ltd Sung Hee-Lee
K172491 11/29/2017 ICONN Square 2.5MM Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K173273 11/09/2017 Aquarius 8600 1417WCI; Aquarius 8600 1717WCI Imaging Dynamics Company Ltd. Nicole Wherry
K173121 11/28/2017 Ankle Fusion Plating System In2Bones SAS Morgane Grenier
K170688 11/28/2017 PITÆStop« implant In2Bones SAS Morgane Grenier
K172300 11/27/2017 CoLink View Plating System In2Bones USA, LLC Rebecca Wahl
DEN170018 11/15/2017 NSS-2 System Innovative Health Solutions (IHS), Inc. Tom Carrico
K171788 11/03/2017 Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amy Stoklas-Oakes
K173410 11/14/2017 n!ce for Planmill Institut Straumann AG Shokoufeh Khodabandeh
K172903 11/22/2017 HemosIL D-Dimer HS 500 Instrumentation Laboratory Co. Shajunath Nirupama
K172849 11/16/2017 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Intellijoint Surgical Inc. Brandon Gingrich
K170900 11/09/2017 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories INTERVENE Group Ltd Homer Trieu
K170662 11/22/2017 Non Contact Infrared Forehead Thermometer Intrinity Global Limited Alex Kwok
K163223 11/02/2017 ORCA (tm) - Operational Rescue Containment Apparatus ISOVAC PRODUCTS, LLC PETER M. JENKNER
K163087 11/02/2017 PixoTest Blood Glucose Monitoring System iXensor Company Ltd. JAMIE WU
K170080 11/02/2017 Neodent Implant System - CM Pro PEEK Abutment JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lechechem
K173329 11/15/2017 jFit Surgical Planner JointVue LLC Mohamed R. Mahfouz
K170666 11/22/2017 The Wrist-Type Fully Automatic Digital Blood Pressure Monitors Joytech Healthcare Co., Ltd. Ren Yunhua
K161923 11/09/2017 J2A SLA Dental Implant System KJ Meditech Co., Ltd. Goong-san Nam
K163579 11/21/2017 KLS Martin Individual Patient Solutions KLS Martin LP Jennifer Damato
K172639 11/03/2017 PALLAS 308/311 Solid-State UV Laser System Laseroptek Co.Ltd Hong Chu
K171589 11/17/2017 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
K170799 11/14/2017 AP 50/30 Insufflator with Insuflow Port LEXION Medical LLC Bernard Horwath
K171136 11/20/2017 LIA Pregnancy Test LIA Diagnostics Anna Couturier
K170473 11/08/2017 C2 femoral stem Limacorporate S.p.A. Antonio Soleti
K173171 11/24/2017 FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. Joan Gordon
K172301 11/02/2017 Mako Partial Knee Application MAKO Surgical Corp. Andrea Dwyer Steiner
K171571 11/30/2017 NexSite HD, Hemodialysis Step Tip Catheter (60cm) Marvao Medical Devices, Ltd. Christopher Davey
K171121 11/17/2017 Masimo Root Monitoring System and Accessories Masimo Corporation Marguerite Thomlinson
K163643 11/16/2017 SIRIO H3 MASMEC SPA Domenico Marino
K172054 11/03/2017 Materialise Glenoid Positioning System Materialise NV Oliver Clemens
K172650 11/20/2017 Materialise PKA Guide System Materialise NV Oliver Clemens
K170513 11/01/2017 MAUSER PG II Sharps Container Mauzer USA LLC Tatiana Smoleeva
K171131 11/08/2017 MHC Standard and NRFit Tip Syringes Mazza Healthcare, LLC. Michael A. Mazza
K171610 11/16/2017 MC3 QuickFlow Dual Lumen Catheter MC3 Incorporated Martha Rumford
K172347 11/01/2017 GMK Hinge, GMK Revision Medacta International SA Stefano Baj
K170690 11/29/2017 M-Vizion Femoral Revision System Medacta International SA Stefano Baj
K172344 11/13/2017 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) MEDAX S.R.L. UNIPERSONALE Stefano Cavalieri
K171618 11/16/2017 Symetrex Long Term Hemodialysis Catheter Medcomp (DBA Medical Components, Inc.) Courtney Nix
K163595 11/13/2017 IMPIX 3D Print Cages MEDICREA INTERNATIONAL S.A. David Ryan
K171114 11/27/2017 HEALIX ADVANCE KNOTLESS Anchor Medos International SARL Julie Vafides
K171376 11/02/2017 DynaNail TTC Fusion System MedShape, Inc. Courtney Kline
K172373 11/02/2017 Compound W Nitro-Freeze Medtech Products Inc. Jean Boyko
K172328 11/02/2017 SOVEREIGNÖ Spinal System Medtronic Sofamor Danek Kanesha Hines
K172984 11/20/2017 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Medtronic, Inc. Lisa Stone
K170341 11/02/2017 Medussa-PL Cage Medyssey USA, Inc. Shawn Kim
K172277 11/03/2017 Phlebo Press DVT Model Mego Afek AC Ltd. Reuven Yunger
DEN170058 11/15/2017 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay Memorial Sloan-Kettering Cancer Center Christine England
K173136 11/16/2017 Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses Menicon Co., Ltd. Kenichi Tanaka
K172936 11/30/2017 DestikneeÖ Total Knee System Meril Healthcare Pvt. Ltd. Bhavik Gondaliya
K172637 11/30/2017 HeRO Graft Merit Medical Systems, Inc. Susan Christensen
K170517 11/16/2017 Merits Model R106/R136 Rehab Wheelchair Merits Healthcare Industries (suzhou) Co., LTD. Guangyong Li
K172689 11/29/2017 DESCRIBE PFD Patch Merz North America, Inc. Misty DÆOttavio
K170916 11/28/2017 Portable Nebulizer MicroBase Technology Corporation Molly Hsieh
K173183 11/22/2017 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation Minoti Patel
K173385 11/30/2017 Graft Delivery, DePuy Synthes Micromedics, Inc. (d/b/a Nordson MEDICAL) Kristi Brezinka
K172218 11/21/2017 MIM û Y90 Dosimetry MIM Software Inc. Lynn Hanigan
K161855 11/27/2017 LED Curing Light MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K173305 11/17/2017 NeuroBlate System Monteris Medical, David H. Mueller
K172620 11/08/2017 SyndesMetrics Syndesmosis Repair System Mortise Medical LLC Robert Hoy
K173290 11/28/2017 DuoFLEX Coil Suite MR Instruments, Inc Leon Ricord
K171155 11/21/2017 Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi Inc. Kimihiko Satoh
K163414 11/21/2017 Ultrasonic scaler NANNING VV DENTAL CO., LTD. Liang chaojun
K173423 11/17/2017 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled Nano4Imaging GmbH Christoph R. Manegold
K172711 11/03/2017 Comet-PLUS Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K173377 11/28/2017 3.0T 16ch Breast Coil NeoCoil, LLC Michael Leigh
K171884 11/22/2017 I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc Brian Sullivan
K172539 11/22/2017 CereTom Elite NeuroLogica Corporation, a Subsidiary of Samsung Electronics Ninad Gujar
K171902 11/10/2017 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc Rainer Harjunpaa
K173044 11/20/2017 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Ningbo Albert Novosino Co.,Ltd. Ningbo Albert Novosino
K171466 11/29/2017 NobelDesign, DTX Studio Design Nobel Biocare AB Charlemagne Chua
K170464 11/07/2017 StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation Eliza Wang
K173314 11/16/2017 LessRay System NuVasive, Incorporated Manthan J. Damani
K172497 11/24/2017 NuVasive AttraX Scaffold NuVasive, Incorporated Marysa E. Loustalot
K172979 11/06/2017 NuVasive« Growth Rod Conversion Set NuVasive, Incorporated Olga Lewis
K173030 11/21/2017 Vertera Spine Cohere Cervical Interbody Fusion Device NuVasive, Incorporated Michelle Cheung
K171158 11/17/2017 Single Use Electrosurgical knife Olympus Medical Systems Corp. Toshiyuki Nakajima
K170811 11/27/2017 Single Use Retrieval Nitinol Basket V OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K172535 11/16/2017 Bipolar applicator CELON ProCurve V Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K172462 11/22/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K173247 11/08/2017 Surgical Planning Software version 1.1 Ortho Kinematics, Inc Adam Dietz
K172437 11/02/2017 CONSTRUX« Mini PTC Spacer System, FORZA« PTC Spacer System, PILLAR« SA PTC Spacer System Orthofix Inc. Natalia Volosen
K173051 11/16/2017 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl Gianluca Ricadona
K170534 11/09/2017 PROLIXUS TOTAL KNEE SYSTEM OTIS Biotech Co., Ltd. Sanjay Lingot
K172925 11/30/2017 Contact Lens Case, Model: A-1, B-1 P L Overseas Limited Maggie Li
K172176 11/21/2017 Parkell Universal Adhesive Parkell, Inc. David Mott
K172685 11/21/2017 LiverMultiScan Perspectum Diagnostics Ltd Jaco Jacobs
K173187 11/16/2017 MobileDiagnost M50 Philips India Limited Nidhi Bathwal
K172226 11/09/2017 MX40 Release B.07 Philips Medical Systems Theresa Poole
K171850 11/09/2017 Philips CT Big Bore Philips Medical Systems (Cleveland) Inc. Michael Chilbert
K172822 11/22/2017 Azurion series R1.2 Philips Medical Systems Nederland BV Jeanette Becker
K171385 11/14/2017 Planmeca Romexis Planmeca Oy Lars Moring
K171868 11/11/2017 A1AT Genotyping Test Progenika Biopharma S.A., a Grifols Company Diego Tejedor
K172859 11/22/2017 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder Prosomnous Sleep Technologies David Kuhns
K172790 11/08/2017 ER-REBOA Catheter Prytime Medical Devices, Inc. Brian Young
K173446 11/17/2017 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K171350 11/29/2017 Collision Check Radformation, Inc. Kurt Sysock
K173233 11/30/2017 ReliefBand 1.5 ReliefBand Technologies Dave Hartman
K171543 11/16/2017 Renovis Surgical Hip Replacement System Renovis Surgical Technologies Anthony DeBenedictis
K170853 11/02/2017 InnoSpire Go Respironics Respiratory Drug Delivery (UK) Ltd. Filippo Quadrelli
K163694 11/07/2017 Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs Ltd. Sue Chuang
K170868 11/30/2017 FIXIT Threaded Anchor System S.B.M SAS Science for Bio Materials Anne Cospin-Latapie
K170398 11/21/2017 S.I.N. Dental Implant System S.I.N. û Sistema de Implante Nacional S.A. Denis Oliveira
K172229 11/22/2017 GC85A Samsung Electronics Co.,Ltd. Jaesang NOH
K172514 11/17/2017 Trak Plus Male Fertility Testing System Sandstone Diagnostics, Inc. Ulrich Schaff
K172674 11/02/2017 Sapphire Cervical Implant System Sapphire Medical Group Anthony Ruggiero
K172292 11/24/2017 SALUS - Hygiene Instrument Reprocessing Container SciCan Ltd. Teresa Boyce
K172130 11/16/2017 Resorbable Mesh Device SeaSpine Orthopedics Corporation Jenny Fam
K173112 11/21/2017 LAP-iX Sejong Medical Co., Ltd. Yoojung Choi
K173111 11/28/2017 LAP-iX Suction Irrigation Sejong Medical Co., Ltd. Yoojung Choi
K172761 11/17/2017 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Shanghai New Century Dental Materials Co., Ltd. Charles Shen
K173169 11/20/2017 Rapid Family SharpLight Technologies Ltd. Ilan Sharon
K172678 11/24/2017 THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE Shen Wei USA Inc. Cheryl Reep
K171578 11/30/2017 Infrared thermometer Shenzhen Aeon Technology Co.,Ltd. Applicant Wendy
K170965 11/03/2017 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd. Yang Gang
K171901 11/15/2017 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai
K162718 11/30/2017 Foot Drop System (Model XFT-2001D) SHENZHEN XFT Medical Limited JIANG XIAOYING
K171742 11/17/2017 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K173378 11/20/2017 syngo«.via protoNeo (Version VA20) Siemens Healthcare GmbH Abhineet Johri
K172531 11/14/2017 Biograph mMR with mMR Angio Transfer Option Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173023 11/17/2017 Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold Siemens Medical Solutions USA, Inc. Tabitha Estes
K172020 11/29/2017 Arlington PLIF/TLIF Cage Signature Orthopaedics Pty Ltd. Declan Brazil
K172019 11/29/2017 Brisbane ALIF Device, Gladstone ALIF Device Signature Orthopaedics Pty Ltd. Declan Brazil
K170946 11/24/2017 Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant Skanray Technologies Private Limited Mahadevan J.
K170071 11/09/2017 SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer Sleep Group Solutions Rani Ben-David
K171743 11/17/2017 Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves Smart Glove Corporation Sdn.Bhd Khon Pu Foo
K172451 11/17/2017 Dr.MUSIC 3s SmartMedicalDevice Co., Ltd. Dong-Min Lee
K171934 11/30/2017 Birmingham Hip (BH) Dual Mobility Insert Smith & Nephew, Inc. Mike Scott
K173331 11/16/2017 JOURNEY II XR Knee Instruments Smith & Nephew, Inc. Shereen Bienz
K171073 11/21/2017 Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc. Kim Phan
K172458 11/09/2017 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit Smiths Medical ASD, Inc. Mikael Evans
K170022 11/16/2017 Klockner Vega TiBase for CEREC SOADCO S.L. MARIA MITJANETA
K172622 11/21/2017 Microcyn Antimicrobial Skin and Wound Cleanser Sonoma Pharmaceuticals Brian W. Martin
K172851 11/15/2017 Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc. Brian Martin
K163634 11/06/2017 External Hex Implants SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K172687 11/27/2017 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Stephanie Byrum
K170235 11/29/2017 Lucent« Spinal Elements Inc. Julie Lamothe
K173175 11/01/2017 Paramount Anterior Cervical Cage System Spine Wave, Inc. Yvonne Riley-Poku
K171492 11/20/2017 B7 2C Occlusion Balloon Spiration, Inc. Cheryl Frederick
K172223 11/17/2017 SleepRight ProRx Custom Dental Guard Splintek, Inc. Samantha Schroeder
K173232 11/02/2017 myMerlin(TM) Mobile Application Model APP1001 St. Jude Medical Jennifer Dunham
K172472 11/17/2017 Micro-MEC 1.8% Glutaraldehyde Monitor Strip STERIS Corporation Jennifer Nalepka
K172644 11/03/2017 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated Elizabeth Greene
K171769 11/14/2017 Straumann PURE Ceramic Implants Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K171757 11/27/2017 Straumann Screw Retained Abutments Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K172921 11/20/2017 Stryker Self-Punching ICONIX Stryker Katie Farraro
K170725 11/13/2017 Stryker Universal Mesh Stryker Jonathan Schell
K170773 11/08/2017 Stryker Universal Mesh Stryker Gregory Gohl
K173135 11/27/2017 VariAx 2 System Stryker GmbH Paul Nelson
K172856 11/16/2017 Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider Stryker Sustainability Solutions Scott English
K171911 11/09/2017 Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K172157 11/14/2017 DePuy Synthes Femoral Recon Nail System Synthes (USA) Products, LLC Alexander Zwahlen
K172604 11/06/2017 XW-100 Automated Hematology Analyzer for CLIA Waived Use Sysmex America, Inc. Michelle Abraham
K172124 11/09/2017 Televere Podiatry Digital Imaging System Televere Systems Randell Quaal
K163646 11/02/2017 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene SA Maria Victoria Quiroga
K172995 11/21/2017 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation Liang Lu
K170915 11/21/2017 TXM Hydrophilic Guidewire Texas Medical Technologies, Inc. Aaron Chiu
K170914 11/21/2017 TXM Support Catheter Texas Medical Technologies, Inc. Ed Anderson
K170053 11/28/2017 Meridian PM The Center for Craniofacial & Dental Sleep Medicine Samuel Cress
K172407 11/02/2017 Duracetal The Myerson Company Limited Cindy Buchoon-Legendre
K171226 11/28/2017 TOKUYAMA UNIVERSAL BOND Tokuyama Dental Corporation Fumia Takahashi
K171370 11/01/2017 IMAGEnet 6 Ophthalmic Data System Topcon Corporation James Lorkowski
K171488 11/27/2017 PSLT for PASCAL Streamline Topcon Medical Laser Systems, Inc. Sweta Srivastava
K172878 11/17/2017 Vantage Titan 3T, MRT-3010/A7, M-Power GX Toshiba Medical Systems Corporation, Japan Paul Biggins
K172178 11/16/2017 Minimally Invasive Bunion Plating System Trilliant Surgical, LTD Jonathan Olson
K170578 11/24/2017 True Function Adjustable Herbst Appliances True Function Laboratory, Inc. Frank Madrigal
K170545 11/21/2017 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument Ltd. Yang Jian-Hao
K172241 11/20/2017 Tyece OTC EMS System, Model EM35 Tyece Ltd. Parshid Falahati
K172424 11/22/2017 VelofixÖ SA Cervical Cage U&I Corporation Jee-Ae Bang
K171392 11/09/2017 ulrichINJECT CT motion ulrich GmbH & Co. KG Sven Erdmann
K162812 11/01/2017 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc UNOMEDICAL A/S John M. Lindskog
K170544 11/17/2017 Langston dual lumen catheter Vascular Solutions, Inc. Jake Schultz
K172111 11/22/2017 Vevazz LED Vevazz, LLC Jamie Fettig
K170859 11/14/2017 Dolphin/IQ and Dolphin/4D Viasonix Ltd. Dan Manor
K163472 11/16/2017 Intra.Ox Handheld Tissue Oximeter VIOPTIX, INC. MARK LONSINGER
K173086 11/07/2017 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Visioneering Technologies, Inc. Stephen Snowdy
K163453 11/02/2017 VitalPatch« VitalConnect Platform VITAL CONNECT, INC. KEVIN POTGIETER
K172050 11/21/2017 Follicle Aspiration Set, Reduced Single Lumen Vitrolife Sweden AB Anja Bengtzelius
K171815 11/15/2017 Registrado Scan VOCO GmbH M. Th. Plaumann
K172177 11/07/2017 Insulia Diabetes Management Companion Voluntis S.A. Kevin Howard
K172794 11/29/2017 Suction Irrigation Set WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Haobin Li
K172584 11/20/2017 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
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K173265 11/07/2017 UltraVision 2 Diagnostic Ultrasound System WinProbe Corporation Guy Scott
K171044 11/21/2017 Climax Personal Lubricant WSM Investment LLC, dba Topco Sales Adrian Mendoza
K171961 11/17/2017 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) Xiamen Compower Medical Tech. Co. Ltd. Lifen Chen
K172144 11/01/2017 CoolSculpting System ZELTIQ Aesthetics Ewald Riechert
K171873 11/15/2017 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Zhonghong Pulin Medical Products Co., Ltd. Jinge Li
K172767 11/30/2017 Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid Zimmer, Inc. Ehab Esmail
K161652 11/28/2017 DIAZIR ZXTGY (BEIJING) TECHNOLOGY CO., LTD N/A N/A


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