FDA 510(k) Decisions During July, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K171003 07/21/2017 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K170563 07/27/2017 3M Comply Hydrogen Peroxide Indicator Tape 3M Company Nadia Battah
K171908 07/11/2017 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M Company Melissa Forth
K171837 07/25/2017 TomoTherapy Treatment Delivery System with iDMS Accuray Incorporated Keith Picker
K163406 07/11/2017 Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System ACON LABORATORIES INC. QIYI XIE
K170587 07/06/2017 On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis ACON Laboratories, Inc. Qiyi Xie
K163062 07/25/2017 PHMB Antimicrobial Foam Wound Dressing Advanced Medical Solutions Ltd. Kay McGrath
K163598 07/31/2017 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator ADVANCED STERILIZATION PRODUCTS NAZANIN YACOBI
K162815 07/13/2017 SterilContainer S System AESCULAP, INC Paul Amudala
K170434 07/03/2017 Enterprise Imaging XERO Viewer 8.1 Agfa HealthCare N.V. Jodi Coleman
K163057 07/12/2017 Relizorb Alcresta Therapeutics, Inc. Robert Gallotto
K171242 07/14/2017 Alma LipoFlow System Alma Lasers Inc. Rekha Anand
K171265 07/28/2017 Otowave 302 Portable Tympanometer Amplivox Ltd Chris Roerig
K171282 07/27/2017 Fully Automatic Blood Pressure Monitor Andon Health Co., Ltd Liu Yi
K170775 07/19/2017 Mini Stick ENVI Non-Vascular Introducer Kit AngioDynamics, Inc. Hans Kjolhede
K171701 07/20/2017 GelPOINT Path Transanal Access Platform Applied Medical Resources Corp. Corinne Weisheit
K171544 07/18/2017 Arterys Viewer Arterys Inc. Golnaz Moeini
K170326 07/20/2017 dynaMX Intramedullary Implant Arthrex, Inc. Howard L. Schrayer
K171613 07/01/2017 ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K162153 07/14/2017 Integra« CAPTUREÖ Screw System & Integra« Ti6« Internal Fixation System ASCENSION ORTHOPEDICS GABRIELLA BECKER
K170223 07/21/2017 Progreat ASHITAKA FACTORY OF TERUMO CORPORATION LAUREN P. NITAHARA
K170978 07/19/2017 Embrace Neonatal MRI System Aspect Imaging Ltd. Israel Citron
K170407 07/17/2017 BD ChloraShield IV Dressing with CHG Antimicrobial Avery Dennison Belgie BVBA Lisa Bartakovics
K163025 07/20/2017 DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd. Sophia Shao
K160337 07/07/2017 Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns BAM CORPORATION LIMITED MARY MEJAES
K171812 07/19/2017 Nio Color 2MP (MDNC-2123) Barco NV Helena Soenen
K171404 07/17/2017 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) BAUSCH + LOMB Incorporated Glenn A. Davies
K170974 07/03/2017 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK Becton, Dickinson and Company Li Zhou
K162398 07/06/2017 CO2 Laser Therapy Systems BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. XIN WANG
K162950 07/22/2017 VITEK MS bioMerieux, Inc. Nathan Hardesty
K171054 07/28/2017 Biomet Knee Joint Replacement Prostheses Biomet, Inc Jason Heckaman
K170143 07/06/2017 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, Bionime Corporation Kay Wu
K170600 07/25/2017 CARTO 3 EP Navigation System, Version 6.0 and Accessories Biosense Webster, Inc. Phoung Chau
K170997 07/25/2017 CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc. John Jimenez
K162853 07/14/2017 Bonafix TWO - Dental Implant System BONAFIX SURGICAL AND DENTAL IMPLANTS Juan Tezak
K162856 07/18/2017 Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) Bonart Co., Ltd. Bankson Tsai
K171454 07/07/2017 Interject Injection Therapy Needle Catheter Boston Scientific Corporation Tara Paul
K170815 07/06/2017 PSA Cable Boston Scientific Corporation Melissa Klamerus
K171913 07/25/2017 Rubicon 14, 18 and 35 Support Catheters Boston Scientific Corporation Ka Zoua Xiong
K170757 07/14/2017 Aegis Transit System Boston-Biomedical Associates Lauren Baker
K170686 07/14/2017 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs Brightway Holdings Sdn. Bhd. G. Baskaran
K163536 07/26/2017 MALDI Biotyper CA (MBT-CA) System, MBT smart CA System BRUKER DALTONIK GMBH MARKUS KOSTRZEWA
K171132 07/31/2017 Carefusion NeutraClear Needle-free connector CAIR LGL Delphine Molinari
K170550 07/13/2017 Coveris Cervical Cage System Camber Spine Technologies Ryan Gaffney
K171957 07/19/2017 MaxZero Extension Sets with Needless Connector Carefusion 303 Inc. Viviana Lai
K162858 07/24/2017 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST Careplus (M) SDN BHD LIM KWEE SHYAN
K162991 07/24/2017 YELLOW 560 Fluorescence Module Carl Zeiss Meditec AG Peter Schrutka-Rechtenstamm
K171588 07/31/2017 NuBODY Skin Toning Device Carol Cole Company dba NuFACE Donald Ellis
K170870 07/06/2017 Site~Rite Halcyon Diagnostic Ultrasound System CHISON Medical Imaging Co., Ltd. Qifei Liu
K162609 07/06/2017 ClearPath Aligner ClearPath Orthodontics Ltd Waqas Wahab
K171747 07/14/2017 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and Codman & Shurtleff, Inc. Vivian Perez
K171653 07/03/2017 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up Codman & Shurtleff, Inc. Yoon Hee Beatty
K170541 07/07/2017 Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. Danielle Lindner
K171855 07/21/2017 External Moisturizing Gel Combe Incorporated Richard Grabarz
K162934 07/10/2017 Biodesign Parastomal Hernia Repair Graft Cook Biotech Incorporated Perry W. Guinn
K163031 07/27/2017 Bunegin-Albin Air Aspiration Set COOK INCORPORATED JOHNATHAN LIU
K163353 07/11/2017 Needle's Eye Snare Retrieval Set - 54cm Cook Incorporated Thomas Kardos
K171999 07/31/2017 Performer Introducer Cook Incorporated Jennifer Allman
K163318 07/14/2017 Soules Intrauterine Insemination Catheter Cook Incorporated Naomi N. Funkhouser
K171602 07/28/2017 Williams Cystoscopic Injection Needle Cook Incorporated Rebecca Odulio (Li-chun Liu)
K171623 07/31/2017 Nasal Pancreatic Drainage Set Cook Ireland Ltd Orla Gunning
K170660 07/13/2017 Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula CooperSurgical, Inc. Roaida Johnson
K170808 07/13/2017 Unity Total Knee System Corin USA Limited Rachel King
K170100 07/18/2017 CreoDent Solidex Customized Abutment and Screw CreoDent Prosthetics, Ltd. Calvin Shim
K171087 07/07/2017 AXON IR Heat Lamp Crystal Medtech, LLC Nelson Marquina
K171522 07/14/2017 truFreeze Rapid AV Spray Kit CSA Medical, Inc. Sherrie Coval-Goldsmith
K172041 07/27/2017 truFreeze System CSA Medical, Inc. Sherrie Coval-Goldsmith
K171290 07/19/2017 Vela RX PTA Balloon Dilatation Catheter Curatia Medical Jessica Chiu
K163714 07/18/2017 OSSIX BONE Datum Dental Ltd Arie Goldlust
K171115 07/17/2017 3D Endo Software Dentsply Sirona Karl Nittinger
K163137 07/12/2017 NIRA Beauty Skin Laser Dermal Photonics Corporation David Bean
K170814 07/11/2017 Devon 24 Devon Medical Products (Jiangsu) Ltd. Julian Chu
K171301 07/31/2017 Scanmate Flex DGH Technology, Inc. David Henderson
K170798 07/14/2017 Dictum Health Dictum Health, Inc. Paul Landesman
K170871 07/03/2017 DigniCap Scalp Cooling System Dignitana AB Johan Ericsson
K163150 07/14/2017 ViMove2 DORSAVI LTD DAN RONCHI
K162951 07/28/2017 TUBETECH IV Administration Set Douglas Medical Products, Inc. Doug Johnson
K171539 07/14/2017 Contact Lens Case E-Link Plastic & Metal Industrial Co.,Ltd Marvis Lee
K170769 07/26/2017 wireless thermometer ECH (Changzhou) Medical Instrument Co., Ltd. Yuan Hu
K171339 07/07/2017 EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs ECO MEDI GLOVE SDN. BHD Suresh Kumar
K171824 07/18/2017 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System Edan Instruments Inc Alice Yang
K170503 07/11/2017 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages EIT Emerging Implant Technologies GmbH Barbara Wirth
K170637 07/14/2017 sensiFirm EL Global Trade Ltd Yael Liebes
K171401 07/11/2017 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 ELITechGroup Valerie Gourdon
K163035 07/07/2017 DilaCheck Nitrile Powder Free Examination Glove, (Sterile) Elm Tree Medical, Inc. Eva Martin
K170706 07/03/2017 Equashield Closed System drug Transfer Device (CSTD) Equashield Medical Ltd. Dorit Valal
K161349 07/07/2017 Everyway Incontinence Stimulation System EVERYWAY MEDICAL INSTRUMENT CO., LTD. ROBERT TU
K170729 07/18/2017 Examion X-AQS Examion GmbH Andreas Oppermann
K171018 07/13/2017 Axis Charcot Fixation System, 4.5 to 8.5mm Screw System Extremity Medical, LLC. Brian Smekal
K170786 07/18/2017 Faxitron Bioptics Speciemen Radiography System Faxitron Bioptics LLC Douglas C. Wiegman
K170842 07/31/2017 WEGO-PTFE Foosin Medical Supplies Inc., Ltd. Zhipeng Yang
K152257 07/21/2017 Fujifilm Duodenoscope Model ED-530XT FUJIFILM MEDICAL SYSTEMS U.S.A., INC. AARON GE
K171103 07/28/2017 Lumipulse G TSH-III Immunoreaction Cartridges Fujirebio Diagnostics, Inc. Stacey Dolan
K171669 07/05/2017 g.Nautilus PRO g.tec medical engineering GmbH Christoph Guger
K171800 07/12/2017 OEC Elite MiniView GE Hualun Medical Systems Co.Ltd. Lifeng Wang
K171128 07/14/2017 SIGNA Premier GE Medical Systems, LLC Mary A. Mayka
K171656 07/13/2017 Genesys Spine Apache Interbody Fusion System Genesys Spine Brian J. Bergeron
K171838 07/19/2017 TiLock2 Spinal System Genesys Spine William W. Sowers
K171413 07/14/2017 HAVENÖ Laminoplasty System, CANOPY« Laminoplasty Fixation System Globus Medical Inc. Kelly J. Baker
K171885 07/25/2017 Radiance V4 GMV Soluciones Globales Internet S.A.U. Carlos Illana
K162707 07/14/2017 Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload Golden Stapler Surgical Co., Ltd. Hao Chao
K163648 07/07/2017 Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series Grandway Technology (Shenzhen) Limited Patrick Chow
K163571 07/12/2017 Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. Suzette Chance
K170676 07/13/2017 HD Lumbar Interbody System HD LifeSciences LLC Ian Helmar
K170090 07/14/2017 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J Rogers
K163687 07/19/2017 OLINDA EXM Hermes Medical Solutions AB Joakim Arwidson
K163486 07/24/2017 DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates HNM Total Recon, LLC Noah Roitman
K170318 07/12/2017 NeoFuse Ti3D PLIF/TLIF/Cervical Interbody HT Medical, LLC Robert Compton
K170812 07/26/2017 HygePLUS Alginate Impression Material HYGEDENT INC. Peng Wang
K163177 07/28/2017 ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K162633 07/24/2017 Custom Bars IMPLANT DIRECT SYBRON MANUFACTURING, LLC Reina Choi
K163127 07/31/2017 bellavista 1000 IMTMEDICAL AG BEAT KELLER
K170518 07/14/2017 In2Bones Fracture and Correction System In2BonesUSA, LLC Joe Clift
K163560 07/12/2017 Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative Health, LLC. Rafal Chudzik
K170710 07/14/2017 True Spinal Fixation System Innovative Surgical Designs, Inc. Jon Rinehart
K171559 07/24/2017 True Spinal Fixation System Innovative Surgical Designs, Inc. Jon Rinehart
K171092 07/10/2017 XiniWave II Model ECS322P International Trade Group, Inc. Brent C. Reider
K171699 07/28/2017 da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K170507 07/12/2017 Invacare« TDX« SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx Invacare Corporation Elijah N. Wreh
K170207 07/31/2017 Obturys Itena Clinical Charles Peyre
K170313 07/27/2017 ARIX Ankle Distal Tibia System Jeil Medical Corporation Sejin RYU
K171285 07/24/2017 ARIX Diaphysis System Jeil Medical Corporation Yein Han
K163194 07/14/2017 Neodent Implant System - GM Line JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA Julianne Lechechem
K170941 07/07/2017 RX NC Takeru PTCA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K162992 07/07/2017 Karl Storz UROMAT E.A.S.I. KARL STORZ ENDOSCOPY AMERICA, INC SERKAN SEZER
K163064 07/18/2017 Demi Ultra KERR CORPORATION Mohammad Saad Ansari
K162878 07/13/2017 Kitazato ET Catheters Kitazato Corporation Mari Yazaki
K162881 07/11/2017 Kitazato OPU Needles Kitazato Corporation Mari YAZAKI
K171040 07/31/2017 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range Koelis Laetitia GERVAIS
K170397 07/10/2017 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy D Kossan International Sdn. Bhd. Cho Sow Fong
K163352 07/28/2017 Wheelchair Kunshan Hi-Fortune Health Products Co.,Ltd. HongFa Zhi
K170986 07/13/2017 KATANA Zirconia Block Kuraray Noritake Dental Inc. Yasujiro Ohara
K171813 07/13/2017 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System L&K BIOMED Co., Ltd. Yerim An
K163159 07/19/2017 Dario Blood Glucose Monitoring System LabStyle Innovations, Ltd. Erez Raphael
K171753 07/21/2017 BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 Leica Biosystems Newcastle Limited Bert Peerboom
K170239 07/05/2017 Leica FL560 LEICA MICROSYSTEMS (SCHWEIZ) AG GRAINNE GRIFFIN
K171448 07/07/2017 Hammertoe Correction System Life Spine Inc. Randy Lewis
K170073 07/25/2017 LightMed Dental Laser System LIGHTMED DENTALTECHNOLOGY CORP. APRIL CHENG
K171515 07/26/2017 NHAC 16 LMT Medical Systems GmbH Thomas Plein
K171441 07/21/2017 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit Luminex Corporation Wendy Ricker
K170841 07/26/2017 BiopSee, Mobile US MedCom GmbH Johannes Messow
K171333 07/18/2017 20G x 5/8 Pro-Lock CT Safety Infusion Set Medcomp (dba Medical Components, Inc.) Courtney Nix
K170770 07/25/2017 CT Midline Medical Components, Inc. (dba Medcomp) Courtney Nix
K171439 07/20/2017 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, U Medos International SARL Catherine Kilshaw
K171425 07/20/2017 CONCORDE LIFT Medos International, SARL Karen Sylvia
K171267 07/03/2017 NavLock Trackers Medtronic Navigation Nicole Zimmerman
K171031 07/06/2017 CRESCENTÖ Spinal System Medtronic Sofamor Danek Ankit K. Shah
K170532 07/21/2017 True Form Reshapable Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K163597 07/27/2017 VacLok AT Vacuum Syringe Merit Medical Systems, Inc. Angela Brady
K170219 07/20/2017 Microlife Digital Infrared Ear Thermometer MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K171255 07/25/2017 Monteris Medical NeuroBlate System Monteris Medical, Inc. David H. Mueller
K163136 07/31/2017 Youha electric breast pump NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. Huang Yun Jun
K171754 07/28/2017 NovaPACS Novarad Corporation Doug Merrill
K163005 07/27/2017 TIGR Matrix Surgical Mesh NOVUS SCIENTIFIC AB MATS NORBERG
K170768 07/10/2017 Mini Needle OcuJect, LLC Rebecca K. Pine
K171734 07/25/2017 HP PRO Positioning Device Orfit Industries NV Eddy Marivoet
K171844 07/18/2017 Inspire ICE aka Inspire ICE Clear Brackets Ormco Corporation Tara Bonny
K171780 07/11/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K160712 07/14/2017 VITROS Chemistry Products hsCRP Reagent Ortho Clinical Diagnostics Marlene Hanna
K163048 07/28/2017 Smart Stitching Software System, Image Processing, Radiological OSKO, INC. Richard Jeon
K171698 07/07/2017 Smart Syringe Osprey Medical, Inc. Melanie Hess
K170844 07/03/2017 Gemini-C Hybrid Cervical Interbody System Osseus Fusion Systems, LLC Robert Pace
K171316 07/11/2017 O2Vent W Oventus Manufacturing Pty Ltd Hemangi Malde
K170867 07/25/2017 FTRD System Set Ovesco Endoscopy AG Marc O. Schurr
K170435 07/12/2017 NerveGuard NRFit, NerveGuard LUER PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K170305 07/25/2017 Spinal Manometer NRFit; Spinal Manometer LUER PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K170923 07/24/2017 JAWS(TM) Nitinol Staple System Paragon 28 Frank S. Bono
K170852 07/19/2017 POD Packing Coil Penumbra, Inc. Aditi Kolla
K171055 07/06/2017 Philips BlueControl Philips Electronics Nederland B.V. Gaozhen Hang
K163584 07/07/2017 M3290B Philips IntelliVue Information Center iX Philips Medical Systems Theresa Poole
K171461 07/07/2017 SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Philips Medical Systems DMC GmbH Ming Xiao
K171630 07/25/2017 LumFuse-TP Precifit Medical Ltd ZhenYu (Eric) Wu
K171133 07/11/2017 Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories Qfix Alexandra Nicole Low
K171945 07/28/2017 Discovery Pico, Discovery Pico Plus Quanta System S.p.A. Francesco Dell'Antonio
K171711 07/07/2017 Thunder, Thunder VT, Thunder HR Quanta System S.p.A. Francesco Dell'Antonio
K172025 07/31/2017 Litho 60 quanta system spa Francesco Dell' Antonio
K170067 07/25/2017 Easyret Quantel Medical Bruno Pages
DEN170022 07/19/2017 QuantX Quantitative Insights, Inc Robert Tomek
K171398 07/06/2017 Dermal Cooling System R2 Dermatology ,Inc Kristine Tatsutani
K163295 07/24/2017 Infant Transport Mattress Warmer with Disc RAPID AID CORP. Laureta Prifti
K171666 07/06/2017 MPR2 logO DATALOGGER Raumedic AG Reiner Thiem
K170567 07/06/2017 Tempus Pro Patient Monitor Remote Diagnostic Technologies Ltd Chris Hannan
K162470 07/11/2017 RT300 FES cycle ergometer Restorative Therapies, Inc. Andrew Barriskill
K163633 07/28/2017 cobas HbA1c Test, cobas b 101 system Roche Diagnostics Operations Patty Bates
DEN150053 07/27/2017 FETAL PILLOW SAFE OBSTETRIC SYSTEMS LTD RAJIV VARMA
K171093 07/19/2017 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE Sanrea Healthcare Products Pvt Ltd JOSE PAUL M.
K170182 07/19/2017 CARDIOVIT FT-1 SCHILLER AG ZHENRONG YU
K171046 07/07/2017 SeaSpine Cambria System SeaSpine Orthopedics Corporation Gina Flores
K162816 07/27/2017 SML-OSA2 Appliances SELANE PRODUCTS, INC. JOHN CHRISTIAN
K171615 07/31/2017 Xingyu Nitrile Powder Free Patient Examination Gloves, White color Shandong Xingyu Gloves Co., Ltd Xu Qiang
K171616 07/20/2017 Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color Shandong Xingyu Gloves Co., Ltd Xu Qiang
K170480 07/07/2017 Models 3543A, 4343A, 2929A and A843B Shanghai PZ Medical Technolgoy Co., Ltd. Jeff Moeller
K162312 07/25/2017 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color SHEN WEI USA INC. CHERYL BAILEY-KROLL
K171034 07/10/2017 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Ma Chao
K162698 07/14/2017 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD Jie Rao
K161845 07/31/2017 Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co.,Ltd. Xiaoyun Yang
K162867 07/26/2017 MagDen Dental Implant System SHINHUNG MST Co., Ltd. Lee Sunbyung
K171766 07/12/2017 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Kevin Kong
K171905 07/27/2017 VISCO 360 Viscosurgical System Sight Sciences, Inc. Anne-Marie Ripley
K163589 07/20/2017 SIGN IM Nail SIGN FRACTURE CARE INTERNATIONAL Robert Schmitt
K170613 07/17/2017 Genius Total Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K162219 07/20/2017 CADD« Infusion Disposables Portfolio with NRFitÖ connectors Smiths Medical ASD, Inc. Wendy J. Kivens
K170607 07/17/2017 !M1 Solutions For Tomorrow AB Martin Yngvesson
K171727 07/26/2017 Hydrocleanse Antimicrobial Skin and Wound Care Solution Sonoma Pharmaceuticals Brian W. Martin
K170999 07/12/2017 P50 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K171000 07/11/2017 P60 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K171724 07/24/2017 Rampart L Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K161394 07/06/2017 HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C. STEFANO IRIDIO
K170379 07/19/2017 Disposable Standard Clamp Standard Bariatrics Alison Sathe
K171645 07/25/2017 CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle Strukmyer Medical Pamela Liberto
K171364 07/24/2017 MP LeFort I Plates Stryker Gregory Gohl
K171807 07/18/2017 ES2 Neuromonitoring Accessory Instruments Stryker Corporation Nikin Desai
K171149 07/18/2017 Altrix Temperature Management Wraps Stryker Medical Brian Orwat
K163259 07/28/2017 AXS Offset Delivery Assist Catheter STRYKER NEUROVASCULAR Shazia Hakim
K170388 07/25/2017 ANCHORMAN Tibial Ligament Fixation Device Summit Medical Ltd. Sam Drew
K171105 07/11/2017 AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems Supersonic Imagine Laurence HERMITTE
K170675 07/19/2017 Graftgun Universal Graft Delivery System Surgentec, LLC Travis Greenhalgh
K170955 07/03/2017 Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector Surgical Instrument Service and Savings Inc (dba Medline ReN Brandi Panteleon
K162778 07/21/2017 Portable Slit Lamp Microscope SUZHOU KANGJIE MEDICAL INC Hong Zhu
K171078 07/10/2017 TRI-COMBO PARASITE SCREEN Techlab, Inc. Donna T. Link
K161527 07/21/2017 Teco Creatinine Enzymatic Reagent Kit TECO DIAGNOSTICS, INC. XIAOYAN HU
K170399 07/06/2017 Endoskeleton TO Interbody Fusion Device (IBD) Titan Spine, LLC Jane Rodd
K170549 07/05/2017 TOKUYAMA CUREGRACE Tokuyama Dental Corporation Fumio Takahashi
K171967 07/25/2017 MagVita TMS Therapy System Tonica Elektronik A/S Lise Terkelsen
K170832 07/21/2017 Ultimax-i, DREX-UI80 V1.60 Toshiba Medical Systems Corporation Paul Biggins
K171597 07/21/2017 Vantage Elan 1.5T, V4.0 Toshiba Medical Systems Corporation Paul Biggins
K171962 07/24/2017 Klassic HD« Hip System Total Joint Othopedics, Inc. Chris Weaber
K171749 07/13/2017 Velofix(tm) Interbody Fusion System U&i Corporation Jee Ae Bang
K162510 07/18/2017 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue UG GLOBAL RESOURCES SDN. BHD. WONG SEE KEONG
K171021 07/18/2017 JO Agap? Personal Lubricant United Consortium Stephanie Morris
K162957 07/17/2017 U2 Femoral Head UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K170187 07/28/2017 Photodynamic Therapy Device UVBIOTEK, LLC Dave Oberhelman
K170969 07/05/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc. Peter J. Coronado
K171733 07/12/2017 TrueBeam, TrueBeam STx, Edge Varian Medical Systems, Inc. Sara Muddell
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