FDA 510(k) Applications Received During March, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K170754 03/13/2017 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 3M Company, 3M Health Care Maria Ruiz
K170851 03/22/2017 Anterior Spine Truss System (STS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
DEN170019 03/20/2017 Vitamin D 200M Assay for the Topaz System AB SCIEX LLC Shilpa Sharma
K170788 03/16/2017 CyberKnife Treatment Delivery System Accuray Incorportaed Jyoti Singh
K170763 03/13/2017 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend ACell, Inc. Salman Elmi
K170819 03/20/2017 AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. Brenda Clay
K170948 03/30/2017 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Brenda Clay
K170951 03/31/2017 CardioCel 3D Admedus Regen Pty Ltd Mary E. Donlin
K170634 03/02/2017 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 Advanced Vehicle Concepts Ltd. Mark Nicholls
K170683 03/07/2017 Aesculap Video Assisted Thoracic Surgery (VATS) INstruments Aesculap, Inc. Jessica Stigliano
K170661 03/03/2017 Novosyn Quick Absorbable Suture Aesculap, Inc. Kathy A. Racosky
K170623 03/01/2017 ACE Hemoglobin A1c (HbA1c) Reagent ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC Barbara Phillips
K170957 03/31/2017 ReConnex Pre-Sutured Tendon AlloSource Pamela Vetter
K170626 03/02/2017 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers Inc. Rekha Anand
K170850 03/22/2017 Alma Q Alma Lasers LTD Rekha Anand
K170743 03/10/2017 AngioDynamics Total Abscession Biliary Drainage Catheter AngioDynamics, Inc. Teri Juckett
K170775 03/14/2017 Mini Stick ENVI Non-Vascular Introducer Kit AngioDynamics, Inc. Hans Kjolhede
K170695 03/07/2017 VenaCure EVLT NeverTouch Direct Introducer Sheath AngioDynamics, Inc. Robin Fuller
K170719 03/09/2017 Anzai Respiratory Gating System Anzai Medical Co., Ltd. Naoya Iwasaki
K170825 03/20/2017 SnoreRx Apnea Sciences Corporation James Fallon
K170599 03/01/2017 SureFlo EVD Catheter Arkis BioSciences Inc. Joseph Howell
K170928 03/29/2017 CADence System AUM Cardiovascular, Inc. Marie Johnson
K170635 03/02/2017 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K170897 03/27/2017 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
K170837 03/21/2017 Nio Color 3MP (MDNC-3421) Barco NV Helena Soenen
K170824 03/20/2017 BD Vacutainer Eclipse Signal Blood Collection Needle Becton, Dickinson and Company Eileen Hiller
K170944 03/30/2017 LCD Monitor (MD310C, MD310G, MD210G) BenQ Corporation Calvin KT Chang
K170917 03/29/2017 Bi-Ostetic Bioactive Glass Foam Berkeley Advanced Biomaterials Fran?ois G?nin
K170890 03/27/2017 TELIX K Interbody System Biedermann Motech GmbH & Co. KG Gerd Federle
K170883 03/24/2017 FilmArray NGDS Warrior Panel BioFire Defense, LLC Cynthia Phillips
K170604 03/01/2017 FilmArray Respiratory Panel 2 (RP2) BioFire Diagnostics, LLC Kristen J. Kanack
DEN170017 03/16/2017 FilmArray Respiratory Panel 2 plus (RP2plus) BioFire Diagnostics, LLC Kristen J. Kanack
K170670 03/06/2017 Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) bioMerieux, Inc. Cherece L. Jones
K170600 03/01/2017 CARTO 3 EP Navigation System, Version 6.0 and Accessories Biosense Webster, Inc. Phoung Chau
K170901 03/27/2017 ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 BioSystems S.A. Teresa Maria Cortes
K170628 03/02/2017 BioMonitor 2-AF, BioMonitor 2-S BIOTRONIK, Inc Jon Brumbaugh
K170629 03/02/2017 VITRUVIAN INFILTRATION PUMP Black & Black Surgical, Inc. CYNTHIA REES
K170759 03/13/2017 CRE Pulmonary Balloon Dilatation Catheter Boston Scientific Corporation Jia Huang
K170636 03/02/2017 Fathom-16 Steerable Guidewires Boston Scientific Corporation Keith Neligan
K170815 03/17/2017 PSA Cable Boston Scientific Corporation Melissa Klamerus
K170757 03/13/2017 Aegis Transit System Boston-Biomedical Associates Lauren Baker
K170777 03/15/2017 Bovie J-Plasma Precise FLEX Handpiece Bovie Medical Corporation Rubiela Maldonado
K170816 03/20/2017 Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM Brainlab AG Rainer Birkenbach
K170750 03/13/2017 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG Rainer Birkenbach
K170686 03/07/2017 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs Brightway Holdings Sdn. Bhd. G. Baskaran
K170762 03/13/2017 Cardinal Health Non-Reinforced Surgical Gown Cardinal Health 200, LLC Caroline Miceli
K170792 03/16/2017 Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc. Kara Cutshall
K170755 03/13/2017 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria Wheeler
K170667 03/06/2017 QEVO System with KINEVO 900 Carl Zeiss Meditec AG Christian Muenster
K170638 03/02/2017 Retina Workplace Carl Zeiss Meditec AG Christian Muenster
K170940 03/30/2017 Rickettsia Real-time PCR Assay Centers for Disease Control and Prevention (CDC) Yon Yu
K170894 03/27/2017 Zirconia Dental Ceramics CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD. Moushan Liu
K170870 03/23/2017 Site~Rite Halcyon Diagnostic Ultrasound System CHISON Medical Imaging Co., Ltd. Qifei Liu
K170821 03/20/2017 ChoiceSpineÖ Proliant« Posterior Pedicle Screw and Hook Fixation System Choice Spine, LP Kim Finch
K170942 03/30/2017 The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems Choice Spine, LP Kim Finch
K170953 03/31/2017 Tomcat Cervical Spinal System Choice Spine, LP Kim Finch
K170820 03/20/2017 Capnograph and Oximeter CMI Health Inc. Jiacheng Ren
K170656 03/03/2017 Reinforced Flexible Collagen Nerve Cuff Collagen Matrix, Inc. Peggy Hansen
K170856 03/22/2017 CMS600P2 B-Ultrasound Diagnostic System Contec Medical Systems Co., LTD. Xueyong Li
K170954 03/31/2017 Portable ECG Monitor CONTEC Medical Systems Co.,Ltd Xueyong Li
K170945 03/30/2017 Biodesign Staple Line Reinforcement Cook Biotech Incorporated Perry W. Guinn
K170622 03/01/2017 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component Cook Incorporated Naomi Funkhouser
K170931 03/29/2017 CXI TriForce Peripheral Crossing Set Cook Incorporated Sarah Reeves
K170603 03/01/2017 Tao Brush I.U.M.C. Endometrial Sampler Cook Incorporated Ian Herman
K170616 03/01/2017 van Andel Dilatation Catheter Cook Incorporated Daniel J. Corbin
K170898 03/27/2017 Wittich Nitinol Stone Basket Cook Incorporated Erum B. Nasir
K170660 03/03/2017 Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula CooperSurgical, Inc. Roaida Johnson
K170808 03/17/2017 Unity Total Knee System Corin USA Limited Rachel King
K170869 03/23/2017 LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Covidien Celso Duran
K170833 03/20/2017 EndoFLIP« System with FLIP Topography module Crospon Ltd. John OÆDea
K170810 03/17/2017 CRYOFOS CRYOFOS Medical Gmbh Gerlinde Hornung-Stehling
K170789 03/16/2017 In Reach CurveBeam, LLC Stuti Singh
K170936 03/30/2017 Cutera enlighten III Laser System Cutera, Inc. Bradley Renton
K170734 03/10/2017 Venus Silk.expert Cyden Limited Mike Kiernan
K170872 03/23/2017 Aisys CS2 Datex-Ohmeda, Inc. Michelle Huettner
K170885 03/27/2017 DD cubeX2 HS Dental Direkt GmbH Uwe Greitens
K170849 03/22/2017 SIMPLANT Guide Dentsply Sirona Helen Lewis
K170806 03/17/2017 ATTUNE Cemented Tibial Base, Fixed Bearing DePuy (Ireland) Carol S. Ming
K170748 03/10/2017 GLOBAL UNITE Platform Shoulder System DePuy Ireland UC Carol Sandberg Ming
K170803 03/17/2017 HydroMARK Breast Biopsy Site Markers Devicor Medical Products, Inc. Shawna Rose
K170814 03/17/2017 Devon 24 Devon Medical Products (Jiangsu) Ltd. Julian Chu
K170798 03/17/2017 Dictum Health Dictum Health, Inc. Paul Landesman
K170871 03/23/2017 DigniCap Scalp Cooling System Dignitana AB Johan Ericsson
K170608 03/01/2017 UF(II) Implant System DIO Corporation Jiae Park
K170708 03/08/2017 OWL RF INSULATED CANNULAE Diros Technology Inc. Ron Baker
K170959 03/31/2017 DIXI Medical Microdeep Depth Electrode DIXI Medical Lucie Petegnief
K170918 03/29/2017 Compex Sport Elite DJO, LLC Natalia Shirina
K170903 03/28/2017 Compex Wireless USA DJO, LLC Natalia Shirina
K170930 03/29/2017 RSM 2430C DRTECH Corporation Choul-Woo Shin
K170776 03/14/2017 DTI-1 SLA IMPLANT SYSTEM DTI Implant Sistemleri Sanayi Ticaret Anonim Sirketi Fatih Ormeci
K170733 03/10/2017 ScanX Intraoral View Duerr Dental AG Oliver Lange
K170769 03/14/2017 wireless thermometer ECH (Changzhou) Medical Instrument Co., Ltd. Yuan Hu
K170949 03/31/2017 RadiForce MX315W EIZO Corporation Hiroaki Hashimoto
K170874 03/24/2017 Eko Model E5 System (EME5), Eko DUO Eko Devices, Inc. Connor Landgraf
K170637 03/02/2017 sensiFirm EL Global Trade Ltd Yael Liebes
K170831 03/20/2017 EpiAccess System EpiEP, INc Pamela Bunes
K170970 03/31/2017 Epilaser Epilady 2000 LLC Joseph Miller
K170706 03/08/2017 Equashield Closed System drug Transfer Device (CSTD) Equashield Medical Ltd. Dorit Valal
K170767 03/14/2017 Surgical Stainless Steel Suture, Stainless Steel Suture Ethicon, Inc. Hrishikesh Khatav
K170729 03/09/2017 Examion X-AQS Examion GmbH Andreas Oppermann
K170911 03/28/2017 NEOCERA Advanced Barrier Cream EXELTIS USA Dermatology, LLC Babu Lad
K170786 03/16/2017 Faxitron Bioptics Speciemen Radiography System Faxitron Bioptics LLC Douglas C. Wiegman
K170726 03/09/2017 Biopsy Forceps Fehling Instruments GmbH & Co. KG Ulrike Lindner
K170652 03/03/2017 ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls Fisher Diagnostics Connie Yang
K170687 03/07/2017 Flower Bone Screw Set Flower Orthopedics Corporation Jessica Huang
K170842 03/21/2017 WEGO-PTFE Foosin Medical Supplies Inc., Ltd. Zhipeng Yang
K170663 03/06/2017 Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer Foremount Enterprise Co., Ltd. John Yang
K170701 03/08/2017 GEN_2 and GEN_3 Mechanical Wheelchairs Free Wheelchair Mission Don Schoendorfer
K170858 03/22/2017 FDR AQRO (DR-XD 1000) FUJIFILM Medical Systems U.S.A., Inc. Peter Altman
K170624 03/02/2017 TalarLift STS Fusion Orthopedics, LLC Adam Cundiff
K170714 03/09/2017 Venue GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K170878 03/24/2017 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K170847 03/20/2017 EchoPAC Software Only, EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics Renee Webb
K170823 03/20/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K170741 03/10/2017 GTK Disposable Needle Guides GEOTEK Medikal Ltd Sti Latif Iba
K170606 03/01/2017 Acrylic Herbst Appliance with Micro-Recorder Gergen's Orthodontic Lab Chris Morrison
K170839 03/21/2017 RAPID Web Given Imaging Ltd. Hilla Debby
K170908 03/28/2017 PK AIM Gyrus ACMI Inc. Graham A. L. Baillie
K170794 03/16/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K170676 03/06/2017 HD Lumbar Interbody System HD LifeSciences LLC Ian Helmar
K170664 03/06/2017 Odyssey Micro Catheter Heraeus Medical Components, LLC Margaret Batchelder
K170835 03/20/2017 Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE Hightech Development Martin Boros
K170866 03/23/2017 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 Honsun(Nantong)Co.,Ltd Selina Qian
K170812 03/17/2017 HygePLUS Alginate Impression Material HYGEDENT INC. Peng Wang
K170614 03/01/2017 CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K170730 03/09/2017 JAZZ System, including JAZZ Band Implanet, S.A. Fabienne Larquey Cadiere
K170688 03/07/2017 PITÆStop« implant In2Bones SAS Morgane Grenier
K170881 03/24/2017 ISP Safety Huber Needle Infusion Set Infusion Safety Products, Inc. Alan P. Reid
K170738 03/10/2017 InMode Diolaze XL InMode MD Ltd. Amit Goren
DEN170018 03/17/2017 NSS-2 System Innovative Health Solutions (IHS), Inc. Tom Carrico
K170922 03/29/2017 Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) Innovative Health, LLC. Amy Stoklas-Oakes
K170710 03/08/2017 True Spinal Fixation System Innovative Surgical Designs, Inc. Jon Rinehart
K170854 03/22/2017 HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory Co. Carol Marble
K170672 03/06/2017 Tamper Evident Cap For use with ENFit Syringes International Medical Industries, Inc. Brandon Hunt
K170900 03/27/2017 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 03/03/2017 Non Contact Infrared Forehead Thermometer Intrinity Global Limited Alex Kwok
K170713 03/09/2017 da Vinci Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K170641 03/02/2017 da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes Intuitive Surgical, Inc. Kunal Gunjal
K170644 03/02/2017 da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) Intuitive Surgical, Inc. Kunal Gunjal
K170875 03/24/2017 da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories Intuitive Surgical, Inc. Manjunath Bisalehalli
K170645 03/02/2017 da Vinci Xi EndoWrist Instruments and Accessories Intuitive Surgical, Inc. Kunal Gunjal
K170640 03/02/2017 Endoscope Sterilization Tray Intuitive Surgical, Inc. Kunal Gunjal
K170865 03/23/2017 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories Intuitive Surgical, Inc. Cheryl Wu
K170879 03/24/2017 IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories Intuitive Surgical, Inc. Kunal Gunjal
K170659 03/03/2017 IQ Technologies IQ Technologies Inc. Elli Josef
K170718 03/09/2017 Iridex TruFocus LIO Premiere Iridex Corporation Gloria Dy
K170681 03/06/2017 Continuous Single Culture -NX (CSCM-NX) Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K170602 03/01/2017 Continuous Single Culture-NX Complete (CSCM-NXC) Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K170828 03/20/2017 Cardiac Trigger Monitor Ivy Biomedical Systems, Inc. Nicole Bush
K170926 03/29/2017 BrainPulse 1100 Jan Medical, Inc. Prabhu Raghavan
K170780 03/15/2017 ARIX Foot System (2.3/2.8) Jeil Medical Corporation Yein Han
K170705 03/08/2017 ARIX Wrist System Jeil Medical Corporation Ji won SONG
K170846 03/21/2017 Disposable Insulin Pen Needle Jiangsu Caina Technology Co., Ltd. Jun Lu
K170605 03/01/2017 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Rong Zhong
K170666 03/06/2017 The Wrist-Type Fully Automatic Digital Blood Pressure Monitors Joytech Healthcare Co., Ltd. Ren Yunhua
K170941 03/30/2017 RX NC Takeru PTCA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K170834 03/20/2017 CERABIEN ZR Kuraray Noritake Dental Inc. Yasujiro Ohara
K170799 03/17/2017 AP 50/30 Insufflator with Insuflow Port LEXION Medical LLC Bernard Horwath
K170899 03/27/2017 27HJ713S LG Electronics Jinhwan Jun
K170804 03/17/2017 The Solstice OCT System Life Spine Inc. Randy Lewis
K170919 03/29/2017 The TiBow Expandable Spacer System Life Spine Inc. Randy Lewis
K170761 03/13/2017 LIGHTSonic BUBM Lightmed USA, Inc. Katrina Hsu
K170892 03/27/2017 Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K170772 03/14/2017 Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 ?g/mL Liofilchem s.r.l. Fabio Brocco
K170864 03/23/2017 VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company LLC James Champlin
K170891 03/27/2017 Mako Partial Knee Application MAKO Surgical Corp. Shikha Khandelwal
K170893 03/27/2017 Materialise Glenoid Positioning System Materialise NV Oliver Clemens
K170690 03/07/2017 M-Vizion Femoral Revision System Medacta International SA Stefano Baj
K170910 03/28/2017 Medacta Anatomic Shoulder Prosthesis Medacta International SA Stefano Baj
K170845 03/21/2017 MiniMAX Medacta International SA Stefano Baj
K170841 03/21/2017 BiopSee, Mobile US MedCom GmbH Johannes Messow
K170838 03/21/2017 Medentika CAD/CAM TiBases Medentika GmbH Gerhard Polzer
K170934 03/30/2017 C3 Wave System Medical Components, Inc (Dba Medcomp_ Courtney Nix
K170770 03/14/2017 CT Midline Medical Components, Inc. (dba Medcomp) Courtney Nix
K170782 03/15/2017 Medline UNITE« Snap-Off Screws Medline Industries, Inc. Jennifer Mason
K170639 03/02/2017 HEALIX ADVANCE Anchor with PERMATAPE Suture Medos International SARL Julie Vafides
K170937 03/30/2017 VIPER PRIME navigated inserter Medos International, SARL Karen Sylvia
K170610 03/01/2017 PlasmaBlade T Medtronic Advanced Energy Lydia Sakakeeny
K170679 03/06/2017 CD HORIZON« Spinal System, Medtronic Reusable Instruments for Use with the IPC« POWEREASE« System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION« and IPC« POWEREASE« Systems Medtronic Sofamor Danek Kanesha Hines
K170964 03/31/2017 Zenius Spinal System Medyssey USA, Inc. Shawn Kim
K170658 03/03/2017 Lympha Press Optimal Plus Mego Afek AC Ltd. Reuven Yunger
K170700 03/07/2017 Inqwire Diagnostic Guide Wire Merit Medical Systems Inc. Mark Mullaney
K170668 03/06/2017 HeartSpan Steerable Sheath Introducer Merit Medical Systems, Inc. Alina Stubbs
K170933 03/29/2017 Merit Hydrophilic Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K170916 03/29/2017 Portable Nebulizer MicroBase Technology Corporation Molly Hsieh
K170703 03/08/2017 Single Use Arthroscopic Electrode (with Pencil) Modern Medical Equipment Manufacturing Limited Jerry Cheung
K170724 03/09/2017 NeuroBlate System Monteris Medical David H. Mueller
K170722 03/09/2017 Moxxly Flow Collection System Moxxly, Inc. Cara Delzer
K170655 03/03/2017 Zepto Mynosys Cellular Devices, Inc. Dan Marinsik
K170787 03/16/2017 Powered Wheelchair DYW30A(D09) Nanjing Jin Bai He Medical Apparatus Co., Ltd. Jen Ke-Min
K170848 03/21/2017 Alzair Allergy Blocker Nasaleze International Ltd Matt Duxbury
K170598 03/01/2017 ZeroWire Mobile NDS Surgical Imaging, LLC. Shala Famil
K170677 03/06/2017 Neurovision Nerve Locator Monitor (Nerveana), EMGView Software Neurovision Medical Product Inc. Christine Vergely
K170843 03/21/2017 Alians Fragment Specific Newclip Technics Gaelle Lussori
K170939 03/30/2017 Supplemental Instrument Trays NuVasive Specialized Orthopedics, Incorporated Cora Sim
K170961 03/31/2017 NuVasive CoRoent Small Interlock II System NuVasive, Incorporated Cynthia Adams
K170800 03/17/2017 NuVasive LessRay with Enhanced Tracking NuVasive, Incorporated Manthan J. Damani
K170962 03/31/2017 NuVasive« CoRoent« Thoracolumbar System NuVasive, Incorporated Marysa E. Loustalot
K170768 03/14/2017 Mini Needle OcuJect, LLC Rebecca K. Pine
K170752 03/13/2017 OEC Elite OEC Medical Systems, Inc. Helen Peng
K170811 03/17/2017 Single Use Retrieval Nitinol Basket V OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K170822 03/20/2017 Electronic Caries Detector Ortek Therapeutics, Inc. Mitchell Goldberg
K170647 03/03/2017 Connector System Orthofix Inc. Jacki Koch
K170650 03/03/2017 Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl Gianluca Ricadona
K170620 03/01/2017 ReBOSSIS85 ORTHOREBIRTH Co., Ltd. Yasutoshi Nishikawa
K170844 03/21/2017 Gemini-C Hybrid Cervical Interbody System Osseus Fusion Systems, LLC Robert Pace
K170736 03/10/2017 HySil Impression Materials Osstem Implant Co., Ltd.. Heekwon Son
K170867 03/23/2017 FTRD System Set Ovesco Endoscopy AG Marc O. Schurr
K170813 03/17/2017 ORTHOPANTOMOGRAPH OP 3D PaloDEx Group Oy Terho Turkumaki
K170966 03/31/2017 TONOPORT VI PAR Medizintechnik GmbH & Co. KG Buelent Tek
K170923 03/29/2017 JAWS(TM) Nitinol Staple System Paragon 28 Frank S. Bono
K170693 03/07/2017 Phantom Small Bone Intramedullary Nail System Paragon 28, Inc. Frank S. Bono
K170877 03/24/2017 Parcus SLiK Fix Screw Parcus Medical Paul Vagts
K170704 03/08/2017 The Locking Pediatric Osteotomy Plate (LolliPOP) System Pega Medical Inc. Ariel R. Dujovne
K170852 03/22/2017 POD Packing Coil Penumbra, Inc. Aditi Kolla
K170716 03/09/2017 PercuNav Image Fusion and Interventional Navigation Philips Ultrasound Inc. Peng Cui
K170830 03/20/2017 Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Sarah Pleaugh
K170721 03/09/2017 Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil Precision Surgical, LLC Prash Jayaraj
K170671 03/06/2017 SafeSept Transseptal Guidewire Pressure Products Medical Device Manufacturing LLC Andrew Armour
K170612 03/01/2017 STERILE VINYL EXAMINATION GLOVES, Powder Free Primus Gloves PVT Limited Jose Paul M
K170698 03/07/2017 ALLY(TM) Bone Screws Providence Medical Technology, Inc. Margaret Wong
K170882 03/24/2017 ABL90 FLEX, ABL90 FLEX PLUS Radiometer Medical ApS Soren Boegestrand
K170827 03/20/2017 INTRACEPT Intraosseous Nerve Ablation System Relievant Medsystems Alex DiNello
K170744 03/10/2017 Adhesive Electrodes Reno Medical Ltd. LiMing Ren
K170888 03/27/2017 Renovis S141 Lumbar Interbody Fusion System Renovis Surgical Technologies Anthony DeBenedictis
K170924 03/29/2017 AirFit F20 ResMed Ltd Johanna Wright
K170692 03/07/2017 Respire Pink Series with DentiTrac Respire Medical Holding Jonathan Sandler
K170853 03/22/2017 InnoSpire Go Respironics Respiratory Drug Delivery (UK) Ltd. Filippo Quadrelli
K170678 03/06/2017 Beta-CrossLaps CalCheck 5 Roche Diagnostics Edie Brunt
K170938 03/30/2017 CalSet IGF-1 Roche Diagnostics Lisa K. Klinedinst
K170960 03/31/2017 CoaguChek Vantus System Roche Diagnostics Justin Davis
K170753 03/13/2017 Acculoc Total Knee System RootLoc Co., Ltd. Jungsun Ha
K170643 03/02/2017 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System RTI Surgical, Inc. dba RTI Biologics Jennifer Bonacci
K170868 03/23/2017 FIXIT Threaded Anchor System S.B.M SAS Science for Bio Materials Anne Cospin-Latapie
K170905 03/28/2017 Star Tissue Marker Scion Medical Technologies, LLC Louis Li
K170861 03/23/2017 Premier Shandong Weigao Orthopaedic Device Co., Ltd. Han Wang
K170886 03/27/2017 HOMED Mesh Nebulizer Shenzhen Homed Medical Device Co,.Ltd. Shengming Shi
K170965 03/31/2017 Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd. Yang Gang
K170876 03/24/2017 Passport Series Patient Monitors(Passport 12m, Passport 17m) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K170712 03/09/2017 Accutorr 7/VS-900 Vital Signs Monitor Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Yanhong Bai
K170855 03/22/2017 T-Rex Standalone ALIF SIATS, LLC Robert Compton
K170904 03/28/2017 Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc. Alaine Medio
K170840 03/21/2017 MAGNETOM Terra Siemens Medical Solutions USA, Inc. Milind Dhamankar
K170952 03/31/2017 syngo.CT View&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K170747 03/10/2017 syngo Application Software Siemens Medical Solutions, USA, Inc. Patricia D. Jones
K170613 03/01/2017 Genius Total Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K170967 03/31/2017 Intraskan DC Plus Skanray Technologies Private Limited Mahadevan J.
K170946 03/30/2017 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.
K170648 03/03/2017 ANTHEM CR Total Knee System Smith & Nephew, Inc. Thomas Fearnley
K170887 03/27/2017 EVOS Small Fragment Plating System Smith & Nephew, Inc. Samantha Staubach
K170720 03/09/2017 Portex Blue Line Ultra Paediatric Tracheosomy Tube Smiths Medical ASD, Inc. James Taufen
K170862 03/23/2017 Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope Solace Therapeutics, Inc. Scott Blood
K170758 03/13/2017 Thermage FLX System and Accessories Solta Medical Melissa Thomas
K170607 03/01/2017 !M1 Solutions For Tomorrow AB Martin Yngvesson
K170790 03/16/2017 SAM CRRT Unit, SAM Cassette CRRT Spectral Medical Inc. Danijela Domljanovic
K170902 03/28/2017 Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit SPR Therapeutics, LLC Kathryn Stager
K170956 03/31/2017 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation Tricia Cregger
K170725 03/09/2017 Stryker Universal Mesh Stryker Jonathan Schell
K170773 03/14/2017 Stryker Universal Mesh Stryker Gregory Gohl
K170727 03/09/2017 VariAx 2 Compression Plating System Stryker GmbH Tina Mornak
K170771 03/14/2017 VariAx 2 Foot System Stryker GmbH Paul Nelson
K170913 03/28/2017 Composite Removable Sinus Stent System STS Medical Lena Shlossberg
K170675 03/06/2017 Graftgun Universal Graft Delivery System Surgentec, LLC Travis Greenhalgh
K170955 03/31/2017 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings Inc (dba Medline ReN Brandi Panteleon
K170793 03/16/2017 SuRgical Planner (SRP) Surgical Theater, LLC Kevin Murrock
K170697 03/07/2017 GBR system SURGIDENT Duck-su Hur
K170873 03/23/2017 Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl SwissMediTec GmbH Kurosh Sohi
K170802 03/17/2017 TRAUMACEMÖ V+ Injectable Bone Cement Synthes (USA) Products, LLC Christopher J. Medberry
K170654 03/03/2017 USS System Synthes USA Products LLC Eugene Bang
K170818 03/20/2017 Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC Nicholas Fountoulakis
K170728 03/09/2017 E. HISTOLYTICA QUIK CHEK TECHLAB, Inc. Donna T. Link
K170779 03/15/2017 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein Terang Nusa Sdn Bhd Robert Hill
K170680 03/06/2017 TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant Nadav Reuben
K170915 03/28/2017 TXM Hydrophilic Guidewire Texas Medical Technologies, Inc. Aaron Chiu
K170914 03/28/2017 TXM Support Catheter Texas Medical Technologies, Inc. Ed Anderson
K170909 03/28/2017 Infinix INFX-8000V, V6.40 Toshiba Medical Systems Coroporation Paul Biggins
K170832 03/20/2017 Ultimax-i, DREX-UI80 V1.60 Toshiba Medical Systems Corporation Paul Biggins
K170958 03/31/2017 ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm Tricol Biomedical Inc. Maire Ni Beilliu
K170817 03/20/2017 Halcyon Varian Medical Systems Inc. Peter J. Coronado
K170969 03/31/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K170731 03/10/2017 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight Vatech Co., Ltd Daniel Kim
K170950 03/31/2017 Well-Root ST Vericom Co., Ltd. Hyoshin Chung
K170684 03/07/2017 Firebow Wire Torque Assist Device Vesatek, LLC David Look
K170859 03/22/2017 Dolphin/IQ and Dolphin/4D Viasonix Ltd. Dan Manor
K170751 03/13/2017 MRIdian Linac System with 138-leaf Collimator ViewRay Incorporated Sean Delaney
K170896 03/27/2017 Admira Fusion x-base VOCO GmbH M. Th. Plaumann
K170669 03/06/2017 Insulia Diabetes Management Companion Voluntis S.A. Raffi Krikorian
K170740 03/10/2017 GORE VIABIL Short Wire Biliary Endoprosthesis W.L. Gore & Associates, Inc. Barbara L. Smith
K170784 03/15/2017 PNEUMOCLEAR W.O.M World Of Medicine GmbH Soeren Markworth
K170797 03/17/2017 wettrust D2care Wettrust Korea Co., Ltd. Sungho Lee
K170783 03/15/2017 CX50N(CX50YQS) WIDE Corporation YeoJin Yun
K170781 03/15/2017 MX50N(MX50YQS) WIDE Corporation YeoJin Yun
DEN170015 03/09/2017 Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc Marge Walls-Walker
K170642 03/02/2017 GRAVITYÖ Soft Tissue Repair System Wright Medical Technology, Inc. Michael Mullins
K170889 03/24/2017 HV Screw System Wright Medical Technology, Inc. Tara Conrad
K170968 03/31/2017 PROPHECY INVISION Pre-operative Navigation System Wright Medical Technology, Inc. Alayne Melancon
K170611 03/01/2017 SETx Pedicle Screw System Xenco Medical, LLC Gustavo Prado
K170826 03/20/2017 Perfadex Plus XVIVO Perfusion AB Kathleen Johnson
K170651 03/03/2017 Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle Yangzhou Medline Industry Co., Ltd. Jianzhong Qi
K170709 03/08/2017 CURVE Laser System YOLO Medical, Inc. Robert Krznaric
K170735 03/10/2017 Powder-Free Clear Vinyl Patient Examination Gloves Zibo Yue Fan Medical Products Co, Ltd. Wu Xiaoli
K170711 03/08/2017 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System Zimmer GmbH Roberto Tommasini


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