FDA 510(k) Decisions During April, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
DEN160026 04/06/2017 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia 23andMe, Inc. Lisa Charter
K161884 04/19/2017 Ortho System 3Shape A/S Hanne Nielsen
K163677 04/20/2017 Ortho System 3Shape A/S Hanne Nielsen
K163271 04/10/2017 i-Stat Alinity System with i-Stat Glucose test Abbott Point of Care, Inc. Maria L Figueroa
K170788 04/11/2017 CyberKnife Treatment Delivery System Accuray Incorportaed Jyoti Singh
K170300 04/26/2017 Restrata Wound Matrix Acera Surgical, Inc. Tamas Kovacs
K162925 04/06/2017 AcQGuide Steerable Sheath ACUTUS MEDICAL, INC. Brenda Clay
K163355 04/12/2017 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation Lisa Theama
K170214 04/13/2017 Additive Orthopaedics Locking Lattice Plate Additive Orthopaedics, LLC Greg Kowalczyk
K170951 04/28/2017 CardioCel 3D Admedus Regen Pty Ltd Mary E. Donlin
K163274 04/05/2017 AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument Aggredyne, Inc. Philip C. Speros
K161179 04/13/2017 Intelli-Ox AIR LIQUIDE HEALTHCARE AMERICA CORPORATION Steve Miller
K170075 04/03/2017 AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) AirXpanders, Inc. Belinda Pinedo
K161794 04/14/2017 CENTURION Vision System (Active SentryTM) Alcon Research, Ltd. Paul Swift
K162642 04/10/2017 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit ALERE SCARBOROUGH, INC. SARA HALLOWELL
K163192 04/10/2017 Comfort EC710 ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K170069 04/26/2017 AmCAD-UV AmCad BioMed Corporation Jack Yang
K161596 04/28/2017 Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters AngioDynamics, Inc. Teri Juckett
K160730 04/27/2017 Instrument kits ANTHOGYR Therese CANDAU
K170719 04/05/2017 Anzai Respiratory Gating System Anzai Medical Co., Ltd. Naoya Iwasaki
K170536 04/24/2017 ECG Disposable Lead Wire APK Technology Co., Ltd. Caifang Wang
K163426 04/03/2017 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K163358 04/28/2017 Introcan Safety 3 Closed IV Catheter B.BRAUN MELSUNGEN AG ULRICH JEDELHAUSER
K170537 04/21/2017 Nexxis OR, Nexxis Barco n.v. Eric Caus
K170837 04/05/2017 Nio Color 3MP (MDNC-3421) Barco NV Helena Soenen
K170483 04/11/2017 Bausch + Lomb Sensitive Eyes Plus Saline Solution Bausch & Lomb Incorporated Melissa Thomas
K170052 04/19/2017 Stellaris Elite vision enhancement system Bausch + Lomb Dan Regan
K170386 04/12/2017 BD Ultra-FineÖ Insulin Syringe, BD Ultra-FineÖ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-FineÖ needle and BD Insulin Syringes with Micro-FineÖ IV Needle Becton, Dickinson & Company Riddhish Patel
K162385 04/27/2017 RAPIDEC CARBA NP BIOMERIEUX SA ASA KARLSSON
K162017 04/20/2017 Ross Ru Wound Dressing Gel BIOTD, S.A. Lawrence Pratt
K163171 04/14/2017 CeraClean Bisco, Inc. Ryan Hobson
K162567 04/05/2017 ExactechGPS Total Shoulder Application, Equinoxe Planning Software Blue Ortho Anthony Boyer
K162294 04/21/2017 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS BRIGHTWAY HOLDINGS SDN BHD. G. BASKARAN
K163458 04/04/2017 Zenysis Short-Term Dialysis Catheter C.R BARD. INC. SILVIA DE LA BARRA
K163698 04/11/2017 OptiFix Open Absorbable Fixation System - 20 absorbable fasteners C.R. BARD INC, KATHERINE EARLE
K162441 04/24/2017 PowerPICC Provena Catheters with SOLO Valve Technology C.R. BARD, INC BRYAN STONE
K163001 04/17/2017 PowerFlow Apheresis I.V. Port C.R. BARD, INC. Christoph Wagner von Hoff
K161910 04/20/2017 Cardinal Health Sterilization Wrap CARDINAL HEALTH 200, LLC MEGAN MIDDAUGH
K170580 04/11/2017 Carestream Vue PACS Carestream Health, Inc. Diane Koetter
K163255 04/21/2017 CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor Caretaker Medical, LLC Jeff Pompeo
K170171 04/06/2017 IOLMaster 700 Carl Zeiss Meditec AG Christian Muenster
K170942 04/26/2017 The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems Choice Spine, LP Kim Finch
K170953 04/21/2017 Tomcat Cervical Spinal System Choice Spine, LP Kim Finch
K162891 04/14/2017 Complete Control System COAPT, LLC Blair Lock
K170945 04/28/2017 Biodesign Staple Line Reinforcement Cook Biotech Incorporated Perry W. Guinn
K162104 04/24/2017 C-Flex Ureteral Stent Set COOK INCORPORATED MINJIN CHOI
K170616 04/28/2017 van Andel Dilatation Catheter Cook Incorporated Daniel J. Corbin
K170560 04/04/2017 SAGE Vitrification Kit and SAGE Vitrification Warming Kit CooperSurgical Inc Tove Kjµr
K170869 04/21/2017 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Covidien Celso Duran
K163537 04/21/2017 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga Covidien llc LeeAnne Swiridow
K170833 04/17/2017 EndoFLIP« System with FLIP Topography module Crospon Ltd. John OÆDea
K162120 04/28/2017 Scope-Assist Flushing Sink Custom Ultrasonics Inc. Elizabeth Lazaro
K170936 04/25/2017 Cutera enlighten III Laser System Cutera, Inc. Bradley Renton
K161919 04/05/2017 UltraScan 650 CyberLogic, Inc. Jonathan J. Kaufman
K170220 04/27/2017 OneQ-SL s-Clean Implant System DENTIS CO., LTD. SUN CHU SHIN
K162297 04/18/2017 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set Diazyme Laboratories Abhijit Datta
K160323 04/06/2017 FlowKeepers DK ELECTRONICS, LLC AVERY HUFF
K170930 04/27/2017 RSM 2430C DRTECH Corporation Choul-Woo Shin
K163381 04/14/2017 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC Chirag Shah
K170949 04/27/2017 RadiForce MX315W EIZO Corporation Hiroaki Hashimoto
DEN150048 04/14/2017 gammaCore Non-invasive Vagus Nerve Stimulator electroCore, LLC Mike Romaniw
K163617 04/11/2017 REMbrandt Embla Systems Shane T Sawall
K163435 04/05/2017 Entellus Medical Reinforced Anesthesia Needle Entellus Medical Inc. Megan Bernier
K163509 04/05/2017 XprESS ENT Dilation System Entellus Medical, Inc. Karen E. Peterson
K161743 04/14/2017 Etgar Dental Implant System ETGAR MEDICAL INSTRUMENTS, LTD Yehudit PeÆer
K163523 04/18/2017 ECHELON CIRCULAR Powered Stapler Ethicon Endo-Surgery, LLC Carmen Ortiz
K163645 04/21/2017 DERMABOND PRINEO Skin Closure System Ethicon, LLC Joice Pappan
K162732 04/26/2017 Exactech« Alteon« HA Femoral Stem EXACTECH INC Thomas McNamara
K171045 04/28/2017 Exactech« TruliantÖ Line Extensions Exactech, Inc. Patrick Hughes
K162319 04/28/2017 BabyDance Fertility Lubricant Fairhaven Health, LLC Suzanne Munson
K160967 04/18/2017 Finapres Nova Noninvasive Hemodynamic Monitor FINAPRES MEDICAL SYSTEMS BV IR. IRIS VAN UITERT
K163125 04/10/2017 gekoÖ T-2 and gekoÖ Plus R-2 Neuromuscular Stimulators FIRSTKIND LIMITED NEIL BUCKLEY
K170502 04/13/2017 Patient Positioning System Forte Automation Systems, Inc. Phil Reece
K162068 04/10/2017 ARROW Anatomical Porous glenoid Fournitures Hospitalieres Industrie Patricia Donnard
K170040 04/04/2017 BePOD Cannulated Arthrodesis Screws Fournitures Hospitalieres Industrie PATRICIA DONNARD
K162488 04/06/2017 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K163675 04/25/2017 Processor VP-7000, Light Source BL-7000 FUJIFILM Medical System U.S.A., Inc. Shraddha S More
K170858 04/24/2017 FDR AQRO (DR-XD 1000) FUJIFILM Medical Systems U.S.A., Inc. Peter Altman
K162287 04/06/2017 Synapse 3D Perfusion Analysis FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Jyh-Shyan Lin
K163507 04/25/2017 Triton Sponge System Gauss Surgical, Inc. Artie Kaushik
K170445 04/11/2017 LOGIQ S8 GE Healthcare Bryan Behn
K162722 04/20/2017 HyperSense GE MEDICAL SYSTEMS, LLC GLEN SABIN
K161599 04/06/2017 UNO Negative Pressure Wound Therapy System GENADYNE BIOTECHNOLOGIES, INC. Chien Ming GOH
K163144 04/07/2017 gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) GKE-GMBH Ulrich Kaiser
K163361 04/07/2017 ANTHEMÖ Fracture System Globus Medical Inc. Kelly J. Baker
K163383 04/19/2017 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System GREENS SURGICALS PVT. LTD. Vinay Kumar
K160502 04/19/2017 TEG 6s Hemostasis System Haemonetics Corporation Paige Sweeney
K162930 04/21/2017 Aero Chrome* Select Breathable Performance Surgical Gowns Halyard Health, Inc. David M. Lee
K163461 04/13/2017 Coolief* Cooled RF Probe Halyard Health, Inc. Monica King
K161450 04/27/2017 HAMILTON-C3 HAMILTON MEDICAL AG Katrin Vogt
K163667 04/28/2017 RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) HEALTH BEACONS, INC. NANCY CONFREY
K170511 04/25/2017 NeoFuse HA Enhanced PLIF/TLIF HT Medical, LLC Robert Compton
K161829 04/06/2017 Huvitz Imaging System HUVITZ CO., LTD. KIM EUN-JO
K162236 04/20/2017 Ax Stand-Alone ALIF System INNOVASIS, INC. Marshall McCarty
K170211 04/27/2017 Insight Dental System Insight Dental System Matthew Kaupp
K162296 04/18/2017 OmniPod Insulin Management System INSULET CORPORATION MATTHEW KING
K163256 04/06/2017 Dual Mode Infrared Thermometer Intelliworks LLC Dr. Jessica Leonardi
K163149 04/26/2017 VisualEyes Interacoustics A/S Erik Nielsen
K170120 04/18/2017 EndoRotor Interscope, Inc Jeffrey Ryan
K163443 04/13/2017 Interson USB Ultrasound System Interson Corporation David Asarnow
K170865 04/21/2017 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories Intuitive Surgical, Inc. Cheryl Wu
K162203 04/06/2017 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K162621 04/17/2017 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair Invacare Corporation Elijah N. Wreh
K162679 04/28/2017 IOB Temperature Management System IOB MEDICAL INC JIULIN XIA
K163613 04/04/2017 Bluephase Style 20i IVOCLAR VIVADENT, AG SANDRA CAKEBREAD
K170926 04/28/2017 BrainPulse 1100 Jan Medical, Inc. Prabhu Raghavan
K163160 04/20/2017 Sterile Single-use Infusion Set JiangXi HongDa Medical Equipment Group Ltd. Xiaohua Yang
K162517 04/14/2017 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 JKH Health Co., Ltd. Pu Jiang
K170358 04/21/2017 joimax Endovapor 2 joimax GmbH Wolfgang Ries
K170055 04/13/2017 CAPRI Corpectomy Cage System K2M Nancy Giezen
K161332 04/05/2017 NILE Proximal Fixation Spinal System K2M, INC. NANCY GIEZEN
K163372 04/07/2017 RX Takeru Balloon Dilatation Catheter KANEKA CORPORATION Toshihiko Motomine
K170247 04/18/2017 Lacriflow CL KANEKA PHARMA AMERICA LLC Masaaki Fukunishi
K163516 04/21/2017 Braun No Touch + Forehead NTF3000 Thermometer Kaz USA, Inc., a Helen of Troy Company Rajesh Kasbekar
K163386 04/10/2017 Keos Lumbar IBFD Keos Mark F Schenk
K161341 04/05/2017 LIFESYS PACS LIFETRACK MEDICAL SYSTEMS, INC. ERIC SCHULZE
K162067 04/24/2017 VX130 Ophthalmic Diagnostic Device LUNEAU SAS ISABELLE DURAND
K170593 04/18/2017 Mako Total Hip Application MAKO Surgical Corp. Shikha Khandelwal
K163221 04/04/2017 Mazor X Mazor Robotics Ltd. Ayelet Matia
K161741 04/14/2017 GMK UNI MEDACTA INTERNATIONAL SA Stefano Baj
K162271 04/26/2017 Pro-Lock CT Safety Infusion Set MEDCOMP (MEDICAL COMPONENTS, INC.) COURTNEY NIX
K170088 04/06/2017 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film MEDELA, AG Markus Butler
K170610 04/13/2017 PlasmaBlade T Medtronic Advanced Energy Lydia Sakakeeny
K162655 04/21/2017 StealthConnect Remote Viewing, Planning and Collaboration System MEDTRONIC NAVIGATION, INC. MONICA R. MONTANEZ
K170347 04/04/2017 CD HORIZONÖ Fenestrated Screw Set Medtronic Sofamor Danek USA Lee Grant
K163581 04/14/2017 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments MEDTRONIC SOFAMOR DANEK USA, INC LAVEEDA LEFLORE
K163076 04/05/2017 Segment CMR MEDVISO AB Einar Heiberg
K170964 04/26/2017 Zenius Spinal System Medyssey USA, Inc. Shawn Kim
K170700 04/06/2017 Inqwire Diagnostic Guide Wire Merit Medical Systems Inc. Mark Mullaney
K170668 04/05/2017 HeartSpan Steerable Sheath Introducer Merit Medical Systems, Inc. Alina Stubbs
K163101 04/06/2017 CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set MICROGENICS CORPORATION MINOTI PATEL
K162748 04/24/2017 MindMotionPRO MindMaze SA SYLVAIN BOURRIQUET
K163233 04/06/2017 MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter MIVI NEUROSCIENCE, INC Randy LaBounty
K152192 04/07/2017 LED Curing Light MONITEX INDUSTRIAL CO., LTD. Shu-Lung Wang
K170724 04/07/2017 NeuroBlate System Monteris Medical David H. Mueller
K170132 04/25/2017 MyoCycle Home, MyoCycle Pro MYOLYN, LLC Matthew Bellman
K170598 04/07/2017 ZeroWire Mobile NDS Surgical Imaging, LLC. Shala Famil
K163547 04/11/2017 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 NEUROVIRTUAL USA, INC. Eduardo Faria
K170677 04/05/2017 Neurovision Nerve Locator Monitor (Nerveana), EMGView Software Neurovision Medical Product Inc. Christine Vergely
K170012 04/24/2017 Foot and Hand Motion NEWCLIP TECHNICS Celine CHEVRIER
K163459 04/04/2017 Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation Tom Bento
K162617 04/06/2017 NobleStitch EL NOBLES MEDICAL TECHNOLOGIES II, INC. FAYE DUNN
K160990 04/11/2017 Nova Max Uric Acid Monitoring System NOVA BIOMEDICAL CORPORATION ELIZA WANG
K162927 04/06/2017 PRECICE UNYTE CoCr System NuVasive Specialized Orthopedics, Inc. Cora Sim
K170592 04/26/2017 NuVasive BASE Interfixated Titanium System NuVasive, Incorporated Cynthia Adams
K162361 04/17/2017 Soft Plug Extended Duration 180 Canalicular Plug OASIS MEDICAL, INC. JAMES CHRISTENSEN
DEN160030 04/24/2017 Oculeve Intranasal Tear Neurostimulator Device OCULEVE, INC. ANDY DORAISWAMY
K163469 04/06/2017 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K163332 04/26/2017 Apex Revision Knee System OMNIlife science Christina Rovaldi
K163235 04/20/2017 HEM-9210T Omron Healthcare, Inc. Renee Thornborough
K163021 04/11/2017 HAAG-STREIT FUNDUS MODULE 300 OPTOMED OY Jyri Leskela
K163265 04/07/2017 Kepler II Orbbo Surgical, LLC Eric Garofano
K170260 04/25/2017 BC-001+ Acne Purifier Oriental Inspiration Limited Andy Wu
K160670 04/25/2017 ET US SS Prosthetic system OSSTEM IMPLANT CO., LTD. HEE KWON
K163088 04/21/2017 TSIII BA Fixture OSSTEM IMPLANT Co., Ltd. Hee Kwon
K152830 04/20/2017 K3 OSSTEM IMPLANT CO.,LTD. BYEUNGHUN KIM
K162544 04/04/2017 OsteoMed PINNACLE Driver OSTEOMED KATHRYN A. JAYNE
K163303 04/04/2017 OsteoMed ExtremiFix Mid and Large Screw System OsteoMed LLC Ellen Hong
K162087 04/18/2017 NovoGro OsteoNovus, Inc. Brian M. Schlossberg
K162799 04/25/2017 Cliniview Palodex Group Oy Jouni Karkinen
K170813 04/07/2017 ORTHOPANTOMOGRAPH OP 3D PaloDEx Group Oy Terho Turkumaki
K162154 04/24/2017 Pantheon Medical Balanced Plating System PANTHEON MEDICAL TRAVID BIRD
K162241 04/03/2017 TITAN 3-DÖ Wedge System PARAGON 28 Frank S. Bono
K162785 04/14/2017 Velox Nebulizer System PARI Respiratory Equipment, Inc. Michael Judge
K170215 04/19/2017 LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock Patient Pocket LLC Allen D. Seftel
K163484 04/17/2017 Paxman Scalp Cooler Paxman Coolers Limited Richard PAXMAN
K162447 04/13/2017 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner PENTAX of America, Inc. Krishna Govindarajan
K162151 04/20/2017 PENTAX Medical ENT Video Imaging System PENTAX OF AMERICA, INC. Krishna Govindarajan
K162901 04/20/2017 Penumbra 3D Revascularization Device Penumbra, Inc. Michaela Mahl
K163711 04/05/2017 IQon Spectral CT Philips Medical Systems (Cleveland), Inc. Steven Goldberg
K162838 04/07/2017 Philips iCT CT System Philips Medical Systems (Cleveland), Inc. Christine Anderson
DEN160056 04/12/2017 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. Esther Abels
K170716 04/21/2017 PercuNav Image Fusion and Interventional Navigation Philips Ultrasound Inc. Peng Cui
K170721 04/21/2017 Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil Precision Surgical, LLC Prash Jayaraj
K170411 04/04/2017 ER-REBOA Catheter Prytime Medical Devices, Inc Brian Young
K163329 04/14/2017 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 PULSADERM LLC Gloria Avendano
K163708 04/20/2017 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K162438 04/14/2017 Sofia Influenza A+B FIA on Sofia 2 Quidel Corporation Jennifer S. Rial
K161724 04/28/2017 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) RadioMed Corporation Leah Easley
K170882 04/28/2017 ABL90 FLEX, ABL90 FLEX PLUS Radiometer Medical ApS Soren Boegestrand
K162275 04/21/2017 Randox RX Daytona Plus Alkaline Phosphatase (ALP) RANDOX LABORATORIES LIMITED Pauline Armstrong
K162200 04/28/2017 Randox RX Daytona Plus Magnesium (MG) RANDOX LABORATORIES LTD PAULINE 0 ARMSTRONG
K170377 04/05/2017 TipControl RF INSTRUMENT BIPO ? 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO ? 2.5MM WL 350MM Richard Wolf Medical Instruments Corporation Mike Loiterman
K170678 04/04/2017 Beta-CrossLaps CalCheck 5 Roche Diagnostics Edie Brunt
K170938 04/26/2017 CalSet IGF-1 Roche Diagnostics Lisa K. Klinedinst
K170643 04/14/2017 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System RTI Surgical, Inc. dba RTI Biologics Jennifer Bonacci
K161857 04/28/2017 Salvin Tenting Screw System Salvin Dental Specialties Jennifer Singer
K170406 04/18/2017 Plato MICROCATH 27B Microcatheter Scientia Vascular LLC David Sabodski
K170905 04/27/2017 Star Tissue Marker Scion Medical Technologies, LLC Louis Li
K170145 04/29/2017 Digital TENS Unit SHENZHEN EAPPLY TECHNOLOGY CO., LTD LISA HUANG
K162607 04/20/2017 BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai
K163690 04/20/2017 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yang Zhaohui
K161712 04/05/2017 Arm automatic blood pressure monitor SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K163220 04/06/2017 Atellica CH Phencyclidine (Pcp) Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K170221 04/21/2017 syngo.CT Cardiac Planning Siemens Healthcare GmbH Martin Knoppik
K170315 04/04/2017 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Kevin Kong
K170952 04/28/2017 syngo.CT View&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K162782 04/04/2017 iHelmet Hair Growth System Slinph Technologies Co., LTD Zou Jian
K163387 04/18/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K170887 04/24/2017 EVOS Small Fragment Plating System Smith & Nephew, Inc. Samantha Staubach
K170280 04/28/2017 Smith & Nephew SURESHOT Distal Targeting System V4.0 Smith & Nephew, Inc. Allison Chan
K162108 04/17/2017 Pressio 2 ICP Monitoring System SOPHYSA, SA Jean-Christophe Audras
K170059 04/07/2017 Spectranetics Turbo-Elite Laser Atherectomy Catheters Spectranetics, Inc. Rebecca Spelich
K163246 04/06/2017 Leva Anterior Expandable Spacer System SPINE WAVE, INC. AMY NOCCIOLI
K170268 04/14/2017 FortressÖ Pedicular Fixation System Spineology Inc. Jacqueline Hauge
K170266 04/14/2017 PalisadeÖ Pedicular Fixation System Spineology Inc. Jacqueline Hauge
K170251 04/14/2017 ThresholdÖ Pedicular Fixation System SPINEOLOGY INC. JACQUELINE HAUGE
K170255 04/14/2017 ThresholdÖ V2 Pedicular Fixation System SPINEOLOGY INC. JACQUELINE HAUGE
K162945 04/28/2017 VERIFY ASSERT STEAM Process Challenge Device STERIS Corporation Ganga Kolli
K170070 04/28/2017 VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles STERIS Corporation Anthony Piotrkowski
K163656 04/14/2017 Hoffmann LRF System Stryker GmbH Paul Nelson
K170456 04/05/2017 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Stryker Sustainability Solutions Chelsea Cullen
K162046 04/11/2017 MINNE TIES MMF Suture System SUMMIT MEDICAL, INC. Nicole Dove
K170572 04/26/2017 Summit Spine Yellowstone Lumbar Interbody Fusion System Summit Spine Eric Buescher
K170582 04/14/2017 Saf-T-Vac Smoke and Fluid Evacuator Surgical Technology Laboratories, Inc Mathew Fairfax
K163363 04/05/2017 SurgTech Thoracolumbosacral (TLS) Posterior Fixation System SurgTech Inc. Xuegong Yu
K162063 04/21/2017 Steri-Cassette and Steri-Cage Sterilization Packaging System Sybron Dental Specialties Jennifer Dzidrums
K163415 04/20/2017 SlimShape System Syneron Medical Ltd. Ruthie Amir
K162382 04/14/2017 Smart Dongle Blood Glucose Monitoring System TaiDoc Technology Corporation Paul Liu
K162636 04/14/2017 Marco Ultra M3, Marco Ultra M4 TAKAGI SEIKO CO.LTD. HAGIWARA TORU
K160680 04/19/2017 VisioFocus Mini, VisioFocus Smart TECNIMED S.R.L. Cinzia Bellifemine
K161114 04/12/2017 HIGH V+ Teknimed, SAS J.D. Webb
K161982 04/05/2017 C-Reactive Protein Kit for use on SPAPLUS THE BINDING SITE GROUP KIRSTY SAMUELS
K162258 04/28/2017 Self Sealing Sterilization Pouches Tianchang Jiarui Packaging Material Co., Ltd. Zhang Ruiqing
K160694 04/07/2017 Disposable Endotracheal tube, sterile, AccuCuff TIANJIN MEDIS MEDICAL DEVICE CO., LTD. ZHENCHUANG YANG
K163269 04/13/2017 Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device TITAN SPINE, LLC JANE RODD
K161353 04/03/2017 ESTELITE BULK FILL Flow TOKUYAMA DENTAL CORPORATION KEITH A. BARRITT
K162354 04/20/2017 Sniper Staple System TRILLIANT SURGICAL LTD Jon Olson
K162661 04/25/2017 SavDenTM MTA Root Canal Filling Materials tYDS Biotech Incorporation Liang-Yu Chang
K162334 04/27/2017 U.S. Laser Worx Patriot 1 family of lasers U.S. Laser Worx Frank Ford
K170731 04/04/2017 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight Vatech Co., Ltd Daniel Kim
K162877 04/07/2017 VOCSN Unified Respiratory System VENTEC LIFE SYSTEMS, INC Joseph Cipollone
K160179 04/21/2017 VivaChek Ino Blood Glucose Monitoring System VIVACHEK LABORATORIES, INC. Julie Zhou
K170385 04/06/2017 CORE M2 Vascular System Volcano Corporation Courtney Moore
K162968 04/10/2017 VORTRAN GO2VENT VORTRAN MEDICAL TECHNOLOGY 1, INC. James Lee
K162159 04/28/2017 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing VR Medical Technologies, LLC Lee Pan
K160499 04/24/2017 Apnea Risk Evaluation System (ARES), Model 620 Watermark Medical Frank Katarow
K162460 04/28/2017 WAViÖ Headset and WAViÖ eSocÖ Single Use Electrode Contacts WAVI, CO ALEXIS VERACRUZ
K170781 04/04/2017 MX50N(MX50YQS) WIDE Corporation YeoJin Yun
K162142 04/27/2017 Accessory Irrigation Adapter WILSON-COOK MEDICAL, INC. THERESA DE PRAT
K153763 04/06/2017 Howell Biliary Aspiration Needle WILSON-COOK MEDICAL, INC. Jennifer McMahan
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