FDA 510(k) Applications Received During September, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
DEN170046 09/05/2017 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe, Inc. Lisa Charter
K173159 09/29/2017 Cervical Spinal Truss System (CSTS) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K173122 09/29/2017 Abbott Architect Free T4 Abbott Laboratories Linda Sohn
K172885 09/21/2017 HydroPICC Access Vascular, Inc Elizabeth Kinnal
K172630 09/01/2017 Kisses Plus Implant System ACHIMHAI Medical Corporation Ji Ho Jung
K173063 09/29/2017 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System ACIST Medical Systems, Inc. Amber R. Luker
K172799 09/18/2017 Positional Sleep Assessment System (PoSAS) software Advanced Brain Monitoring Daniela Soll
K172931 09/25/2017 DUS-6000 Digital Ultrasonic Diagnostic Imaging System Advanced Instrumentations, Inc. Jorge Millan
K172966 09/26/2017 CMS-2000 Central Monitoring System Advanced Instumentations, Inc. Jorge Millan
DEN170075 09/29/2017 ContainOR Advanced Surgical Concepts Ltd. Edward Hyland
K172850 09/20/2017 SterilContainer with PrimeLine Pro Lid Aesculap, Inc. Lisa Boyle
K172895 09/22/2017 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 Ageless Health Industrial Co., Ltd Victor Wan
K172784 09/15/2017 DX-D Imaging Package Agfa HealthCare N.V. Wim Govaerts
K172770 09/14/2017 AIROS 6 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K172779 09/14/2017 AIROS 8 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K173128 09/29/2017 Alamo« C Alliance Partners, LLC Kristiina Gilkey
K172732 09/11/2017 E-CUBE 8 ALPINION MEDICAL SYSTEMS Co., Ltd. Boyeon CHO
K172953 09/26/2017 Acid Etchant American Orthodontics Trang Adams
K172908 09/25/2017 Q-Switched Nd:YAG Laser System AMI Inc. Hae Youn Lee
K172862 09/20/2017 Portable ECG Monitor (ECG3) Andon Health Co., Ltd. Liu Yi
K172701 09/07/2017 BIO-C SEALER Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveira
K173017 09/27/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K173016 09/27/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K173008 09/27/2017 SCS 17-01 Anika Therapeutics, Inc. Steven Chartier
K172981 09/27/2017 Reusable SpO2 Sensors, Disposable SpO2 Sensors APK Technology Co., Ltd. Caifang Wang
K172624 09/01/2017 Voyant 5mm Fusion Device Applied Medical Resources Corporation Andrew Nguyen
K172759 09/13/2017 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K172947 09/26/2017 HALF DOME Posterior Lumbar Interbody System Astura Medical Thomas Purcell
K172742 09/12/2017 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) AtriCure, Inc. Melissa Smallwood
K173031 09/28/2017 AtriClip LAA Exclusion System with Preloaded PRO?V Clip AtriCure, Inc. Melissa Smallwood
K172831 09/18/2017 Perfusor« Space Syringe Infusion Pump System B.Braun Medical Inc Tracy Maddock
K172922 09/25/2017 MMPC-4127F1 Barco N.V. Lieven De Wandel
K173089 09/29/2017 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions Bausch & Lomb Incorporated Melissa Thomas
K173084 09/29/2017 Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation Dhiraj Bizzul
K172912 09/25/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ?g/mL) Beckman Coulter Inc. Shannon Popson
K172783 09/15/2017 Access hs Tnl Beckman Coulter, Inc. Kerrie Sue Oetter
K172787 09/15/2017 Access hsTnl Beckman Coulter, Inc. Jennifer Lee Bennett
K172789 09/15/2017 Specimen Retrieval Bag Beijing HangTian KaDi Technology R&D Institute Liying Zhang
K172846 09/19/2017 Uterine Manipulator Beijing HangTian KaDi Technology R&D Institute Liying Zhang
K172804 09/18/2017 Besmed Peak Flow Meter Besmed Health Business Corp. Lawrence Wu
K172942 09/26/2017 Pristeen (Latex SurgeonÆs Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein Beta Healthcare Products Pvt.Ltd. Boney Moolayil
K173066 09/29/2017 OSSEODUO Shaver and Drill System Bien-Air Surgery SA Adil Slimani
K173138 09/29/2017 Biim Diagnostic Ultrasound System Biim Ultrasound AS Rune Nystad
K172771 09/14/2017 Epic Pro 940 Biolase, Inc Alicia Mszyca
K172971 09/26/2017 BMLS16-1 BioMedical Life Systems, Inc. Gary Bussett
K172731 09/11/2017 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) bioMerieux, Inc. Esther Hernandez
K172944 09/26/2017 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ?g/mL bioMerieux, Inc. Cherece L. Jones
K173139 09/29/2017 Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus Bionime Corporation Kay Wu
K173180 09/29/2017 Mega Plus Spine System BK MEDITECH Co., Ltd. Byoungjun Park
K172843 09/19/2017 TwitchView System Blink Device Corporation Justin Hulvershorn
K172955 09/26/2017 LungVision Tool Body Vision Medical Ltd. Dorian Averbuch
K173184 09/29/2017 Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle Boston Scientific Jennifer Edouard
K172929 09/25/2017 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath Boston Scientific Corporation Daniel FitzDaniel
K172820 09/18/2017 Microscope Navigation Software Brainlab AG Alexander Schwiersch
DEN170078 09/29/2017 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System Brainways Ltd. Ahava Stein
DEN170081 09/29/2017 MALDI Biotyper CA System Bruker Daltonik GmbH Markus Kostrzewa
K172717 09/08/2017 Automatic Tissue Processing Unit BSL Co. Jun Suk Lee
K173143 09/29/2017 Phasix ST Mesh C. R. Bard Inc Tony John
K172932 09/26/2017 True Flow Valvuloplasty Perfusion Catheter C. R. Bard, Inc. Aaron Conovaloff
K172801 09/18/2017 ECG SENTINEL System Cardiomedix, Inc. Zipora David
K172725 09/11/2017 VT Dressing Kits Carilex Medical, Inc. Henry Kao
K173006 09/27/2017 Cefaly Dual CEFALY Technology Jean-Yves Mignolet
K172642 09/01/2017 Orange Non Sterile Powder Free Nitrile Examination Gloves Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K173145 09/29/2017 CereMetrix Silver CereMetrix Corp John A Kelley
K172807 09/18/2017 Silicone Foley Catheter for single use Changzhou Rongxin Medicine Minimal Invasion Technology Ping Liu
K172816 09/18/2017 TiGer SharkÖ System Choice Spine, LP. Kim Finch
K173148 09/29/2017 ACIF coLigne, AG Robert Lange
K172937 09/26/2017 Colorado Therapeutics Xenograft Implant Colorado Therapeutics LLC William Jackson
K172791 09/15/2017 Lumilisse IPL Hair Remover Conair Corporation Mike Cantrell
K172940 09/26/2017 ANCHOR Tissue Retrieval System Conmed Corporation Rachelle D. Fitzgerald
K172671 09/05/2017 HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal Conmed Corporation Lisa Anderson
K172986 09/27/2017 Zmachine Synergy Consolidated Research of Richmond, Inc. dba General Sleep Co Richard Kaplan
K172924 09/25/2017 GentleCath Intermittent Urinary Catheter ConvaTec Limited Hannah Sharp
K173105 09/29/2017 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter Cook Incorporated Samuel Engelman
K173035 09/28/2017 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets Cook Incorporated Erum B. Nasir
K172635 09/01/2017 High-Flo Silver Polyethylene Catheter Cook Incorporated Jessica Swafford
K172980 09/27/2017 Micropuncture Pedal Access Set Cook Incorporated Daniel J Corbin
K173009 09/27/2017 NCompass Nitinol Stone Extractors Cook Incorporated Colin Jacob
K173155 09/29/2017 Pakter Curved Needle Set Cook Incorporated Johnathan Liu
K173068 09/29/2017 Performer Introducer COOK Incorporated Reuben G. Lidster
K173103 09/29/2017 Pivet and Soft-Pass Embryo Transfer Catheter Sets Cook Incorporated Naomi Funkhouser
K172806 09/18/2017 Bencox Mirabo Cup System Corentec Co., Ltd J. S. Daniel
K172707 09/08/2017 Renamel Microfill Cosmedent, Inc Mary Nowak
K172757 09/13/2017 Valleylab FX8 Electrosurgical Platform Covidien llc Sharon McDermott
K172769 09/13/2017 CryOmega Flexx CryoConcepts LP R Sam Niedbala
K172788 09/15/2017 MONETÖ Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation Tosan Onosode
K173185 09/29/2017 SEURATÖ Universal Pedicle Screw System CTL Medical Corporation Tosan Onosode
DEN170047 09/11/2017 Curetis Unyvero LRT Application Curetis GmbH Gail E. Radcliffe
K173101 09/29/2017 Curve Image 2.0 PACS Curve Dental LTD Raul Nemes
K172778 09/14/2017 CheckMyHeart Plus DailyCare Biomedical, Inc Ming Da Lee
K172772 09/14/2017 Freemie Independence, Freemie Liberty DAO Health Dave Paul
K172991 09/27/2017 Advanced Dental Applicance DaSoft Partners Dante Togliatti
K172702 09/07/2017 Tec 820, Tec 850 Datex-Ohmeda, Inc. Trishia Mercier
K173018 09/28/2017 MDR17 Mobile Direct Radiographic System Del Medical, Inc. Tony Bavuso
K172640 09/01/2017 Dentium Implantium & SuperLine Prosthetics Dentium Co., Ltd. Sangpil Yoon
K172872 09/21/2017 DePuy Synthes Femoral Neck System DePuy Synthes Ana Sala Roca
K173072 09/29/2017 Algidex Ag Silver Alginate Wound Dressing DeRoyal Industries, Inc. Sarah Bennett
K172648 09/01/2017 Drive DeVilbiss iGo 2 Portable Oxygen Concentrator DeVilbiss Healthcare, LLC Betty Miller
K173046 09/28/2017 Cocoon Portable Handheld X-Ray System Dexcowin Co., Ltd. Ryu Seung-Bum
K172992 09/27/2017 Diazyme EZ Vitamin D Assay Diazyme Laboratories Abhijit Datta
K172891 09/22/2017 Infrared Thermometer Dongguan HCS Electronics Co., Ltd Angel You
K172828 09/18/2017 Double Medical Cage System Double Medical Technology Inc Yan Zuo
K172830 09/18/2017 Double Medical Femoral Nail System Double Medical Technology Inc. Yan Zuo
K172656 09/05/2017 BiliLux Draeger Medical Systems, Inc. Gale Winarsky
K173075 09/29/2017 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850?l, 3ml) DxNow, Inc. William T. Sharp
K173034 09/28/2017 FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) Echosens Karine Bonenfant
K173164 09/29/2017 Ecolab POU Water Filter Ecolab Inc. Jennifer Willner
K172780 09/14/2017 SD1 Ultrasonic Pocket Doppler Edan Instruments Inc Alice Yang
K173042 09/28/2017 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Edan Instruments, Inc Alice Yang
K173003 09/27/2017 U50 Diagnostic Ultrasound System Edan Instruments, Inc. Alice Yang
K172721 09/08/2017 FOCAL ONE EDAP Technomed, Inc. Hugo Embert
K172660 09/05/2017 Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC Christine Chun
K172888 09/21/2017 EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages EIT Emerging Implant Technologies GmbH Barbara Wirth
K172738 09/12/2017 RadiForce RX560, RX560-AR EIZO Corporation Hiroaki Hashimoto
K172703 09/07/2017 Disposable Snap Electrode Embla Systems Sanjay Mehta
K172935 09/26/2017 Embrace Empatica Srl Simone Tognetti
K173073 09/29/2017 AltiVate Anatomic to Reverse Conversion Module Encore Medical, L.P. Teffany Hutto
K172651 09/05/2017 FMP Extended Liners Encore Medical, L.P. Teffany Hutto
K172811 09/18/2017 EsophyX Z, EsophyX2 HD EndoGastric Solutions, Inc. Steve Hoffman
K172858 09/20/2017 PreOp Epilog Gregor Strobbe
K173019 09/28/2017 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar Ethicon Inc. Melina Escobar
K173162 09/29/2017 GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide Ethicon, Inc Julie Tom Wing
K172722 09/11/2017 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) EUROIMMUN US, Inc. Michael A. Locke
K172919 09/25/2017 EV-804 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K173094 09/29/2017 OrthoVision Ewoo Soft Co., Ltd. Young Seok Kim
K172960 09/26/2017 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use Ezisurg Medical Co., Ltd. Sheng Tian
K172661 09/05/2017 Fetzer Medical Gynecological Forceps Fetzer Medical GmbH & Co. KG Harald Jung
K172952 09/26/2017 Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit Figaro Crowns, Inc. Kyle Rose
K173060 09/28/2017 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version Fisher and Paykel Healthcare Limited Ashley Nguyen
K172819 09/18/2017 LightWalker Laser System Family Fotona d.o.o. Marko Berdajs
K172916 09/25/2017 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 Fujifilm Corporation Randy Vader
K173132 09/29/2017 ASPIRE Cristalle Fujifilm Medical Systems U.S.A., Inc. Jyh-Shyan Lin
K172713 09/08/2017 Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set Fujirebio Diagnostics, Inc. Stacey Dolan
K173037 09/28/2017 Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical Inc. Lynne Davies
K172695 09/07/2017 AIR Anterior Array, AIR Posterior Array GE Healthcare Coils (USA Instruments, Inc.) Mary A. Mayka
K172700 09/07/2017 OEC One GE HUALUN MEDICAL SYSTEMS CO., LTD. Lifeng Wang
K172869 09/20/2017 Discovery XR656 HD GE Hualun Medical Systems Co.Ltd. Kenny Ma
K172714 09/08/2017 LipiVage Genesis Biosystems, Inc. Jim Lafferty
K172810 09/18/2017 PORT-X IV GENORAY Co., Ltd. Ji-Yeon Choi
K172842 09/19/2017 GCE704 Breast Pump Globalcare Chiara Cavagnolo
K173166 09/29/2017 ANTHEM Fracture System Globus Medical Inc. Kelly J. Baker
K173115 09/29/2017 COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS Globus Medical Inc. Kelly J. Baker
K172987 09/27/2017 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) GMAX Industries, Inc. Julia Huang
K172867 09/20/2017 Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange GMP MEDICARE SDN BHD (F25) Noraini Raus
K173157 09/29/2017 Dr's Light2 Good Doctors Co.,Ltd. Sungro Joo
K172765 09/13/2017 Smart Moves Complete Great Lakes Orthodontics Ltd David Graver
K172712 09/08/2017 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler GRI Medical & Electronic Technology Co, Ltd Marty D. Paugh
K172835 09/19/2017 GRI-Alleset Veress Needle GRI Medical and Electronic Technology Co., Ltd. Martin Paugh
K172750 09/12/2017 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) Guangzhou Sonostar Technologies Co., Ltd. Weizhong Cai
K172887 09/21/2017 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K172871 09/21/2017 SpineKure Kyphoplasty System Hanchang Co., Ltd. An Kwon Ho
K172727 09/11/2017 Hemoclip Hangzhou AGS MedTech CO., Ltd Chunqi Han
K172729 09/11/2017 Polypectomy Snare Hangzhou AGS MedTech CO., Ltd Chunqi Han
K172861 09/20/2017 Digital thermometer(with disposable thermometer cover) Hangzhou Hua'an medical&health instruments Co.,Ltd Ahneo Yang
K172870 09/20/2017 Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J Hangzhou Hua'an medical&health instruments Co.,Ltd Ahneo Yang
K173137 09/29/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn. Bhd. Kuan Kam Hon
K172892 09/22/2017 Neuro Assessment System NAS-1000 HeadSense Medical Inc. Richard A. Lotti
K172719 09/08/2017 HealthBeacon HB2 Sharps Bin HealthBeacon Ltd Joyce Power
K173028 09/28/2017 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software HealthSTATS International Pte Ltd Ngak Hwee Chua
K172649 09/05/2017 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor Heidelberg Engineering GmbH Gerhard Zinser
K173070 09/29/2017 HSW Resection Instruments Henke-Sass, Wolf GmbH Anna Reifschneider
K173052 09/28/2017 Heraeus TMW Guidewire Heraeus Medical Components, LLC Margaret Batchelder
K172739 09/12/2017 higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) higi SH LLC Colin Hill
K172629 09/01/2017 Panther Fusion AdV/hMPV/RV Assay Hologic, Inc. Anila K Tarte
K172634 09/01/2017 Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components Howmedica Osteonics Corp aka Stryker Orthopaedics Shahrir Alam
K172821 09/18/2017 Ti-one 101 TS Dental Implant System Hung Chun Bio-S Co.,Ltd. Jethro Liou
K173099 09/29/2017 Fortis and Hana Anterior Cervical Plate System Huvexel Co., Ltd Sung Hee-Lee
K173080 09/29/2017 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) Huvexel Co., Ltd Sung Hee-Lee
K173131 09/29/2017 Rexious Spinal Fixation System Huvexel Co., Ltd Sung Hee-Lee
K172690 09/06/2017 ToFscan Idmed Fr?d?ric BERNERT
K173038 09/28/2017 CuRAS Nd:YAG Laser Ilooda Co., Ltd. Yun-Jung HA
K172745 09/12/2017 ImmuGlo HEp-2 Elite IFA IMMCO Diagnostics, Inc. Kevin Lawson
K173121 09/29/2017 Ankle Fusion Plating System In2Bones SAS Morgane Grenier
K172803 09/18/2017 Infinitt PACS 7.0 Infinitt Healthcare Co.,Ltd. Sang Wook Cho
K173126 09/29/2017 ArisstosÖ Spinal System Ingenium Spine David Brumfield
K173120 09/29/2017 CCM Abutment System InnoBioSurg Co., Ltd. Bo-reum Yoo
K172760 09/13/2017 REST EAZY Appliance Insert Molding Solutions, Inc. Paul Hendrixson
K172798 09/18/2017 Straumann CARES Abutments CoCr Institut Straumann AG Shokoufeh Khodabandeh
K172903 09/22/2017 HemosIL D-Dimer HS 500 Instrumentation Laboratory Co. Shajunath Nirupama
K172849 09/20/2017 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Intellijoint Surgical Inc. Brandon Gingrich
K172943 09/26/2017 Flex-Thread Fibula Pin System IntraFuse LLC Robert Hoy
K172643 09/01/2017 da Vinci Xi Surgical System; da Vinci X Surgical System Intuitive Surgical, Inc. Brandon Hansen
K173085 09/29/2017 invendoscopy E210 System invendo medical GmbH Oliver v. Ruepprecht
K172938 09/26/2017 Disposable Sterile Needle Jiangsu Caina Medical Co., Ltd. Jun Lu
K173005 09/27/2017 SURECELL Gelling Fiber Wound Dressing Jiangsu Newvalue Medical Producst Co.,Ltd Julie Chen
K172989 09/27/2017 Electric Breast Pump Joytech Healthcare Co., Ltd. Ren Yunhua
K173024 09/28/2017 Non-invasive blood pressure measurement systems Joytech Healthcare Co.,Ltd Ren Yunhua
K172941 09/26/2017 CASCADIA Interbody System K2M Nancy Giezen
K172808 09/18/2017 CosmoLock Pedicle Screw System Kalitec Direct, LLC Scott Winn
K172918 09/25/2017 DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) KaVo Dental Technologies, LLC Frank Ray
K173116 09/29/2017 KJ ZIRCONIA Implant System KJ Meditech Co., Ltd Hyukki Moon
K172793 09/15/2017 SKR 3000 KONICA MINOLTA, INC. Tsutomu Fukui
K172723 09/11/2017 Dario LC Blood Glucose Monitoring System LabStyle Innovation, Ltd. Erez Raphael
K172818 09/18/2017 LMT-3000 Lameditech Co., Ltd. Jong Seuk Choi
K172639 09/01/2017 PALLAS 308/311 Solid-State UV Laser System Laseroptek Co.Ltd Hong Chu
K172662 09/05/2017 reVive Perioral LED Technologies, Inc. Lloyd Nelson
K172985 09/27/2017 Ligation Device Leo Medical Co., Ltd. Yunpeng Ma
K172973 09/26/2017 Life Spine Foot and Ankle Plating System Life Spine Inc. Randy Lewis
K173182 09/29/2017 ProLift« Expandable System Life Spine Inc. Randy Lewis
K173047 09/28/2017 The Solstice OCT System Life Spine, Inc. Randy Lewis
K173067 09/29/2017 LightForce LTS Model 1000, 1500, 2500, and 4000 LiteCure, LLC Eric Rock
K172659 09/05/2017 MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly M/s. Meril Endo Surgery Private Limited Umesh Sharma
K172737 09/11/2017 MESIRE - Balloon Sinus Dilatation System M/s. Meril Life Sciences Private Limited Umesh Sharma
K173171 09/29/2017 FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. Joan Gordon
K172890 09/22/2017 SedLine Sedation Monitor Masimo Corporation Matthew Tiacharoen
K172963 09/26/2017 Master-Frank N95 Particulate Respirator Master & Frank Enterprise Co., Ltd Shuge Zhao
K172650 09/05/2017 Materialise PKA Guide System Materialise NV Oliver Clemens
K173039 09/28/2017 TruMatch CMF Titanium 3D Printed Implant Materialise NV Lina Ramirez
K172844 09/19/2017 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K172864 09/20/2017 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Maxter Glove Manufacturing Sdn Bhd Yap Peak Geeh
K172956 09/26/2017 Medicant Mucosal Atomizer Medica Holdings, LLC George Reed
K173170 09/29/2017 Epicardia Anywhere Medicomp, Inc. Sean Marcus
K172677 09/05/2017 Advantage Plus Pass-Thru Medivators Inc. Megan Skaar
K173113 09/29/2017 Medline Disposable Electronic Thermometer Probe Cover Medline Industries, Inc. Dinah Rincones
K172954 09/26/2017 Medline Prevention CoolZone Gown Medline Industries, Inc. Pauline Maralit
K173134 09/29/2017 SENTIO MMG Pedicle Access Needles Medos International SARL Sheree Geller
K173095 09/29/2017 VIPER PRIMEÖ Screws, VIPER PRIMEÖ Screws with Fenestrations, EXPEDIUM« Verse Screws with Fenestrations Medos International SARL Thao Le
K172796 09/15/2017 Flex Robotic System and Flex Transabdominal Drive MEDROBOTICS CORPORATION Linda J Varroso
K173125 09/29/2017 T2 STRATOSPHEREÖ Expandable Corpectomy System Medtronic Sofamor Danek Kanesha Hines
K172626 09/01/2017 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiot Medtronic, Inc. Lisa Stone
K172984 09/27/2017 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
K172756 09/13/2017 Varian cage Medyssey USA, Inc. Shawn Kim
DEN170058 09/25/2017 MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay Memorial Sloan-Kettering Cancer Center Christine England
K172866 09/20/2017 NeuroCap Memory MD INC Abdus-Salaam Muwwakkil
K173136 09/29/2017 Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses Menicon Co., Ltd. Kenichi Tanaka
K172930 09/25/2017 mCare Powder-free Blue Nitrile Examination Gloves Mercator Medical (Thailand) LTD. Dariusz Jan Krezymon
K172936 09/26/2017 DestikneeÖ Total Knee System Meril Healthcare Pvt. Ltd. Bhavik Gondaliya
K172857 09/20/2017 Latitud Hip Replacement System Meril Healthcare Pvt. Ltd. Bhavik Gondaliya
K172637 09/01/2017 HeRO Graft Merit Medical Systems, Inc. Susan Christensen
K173124 09/29/2017 PEEK Biosolution Merz Dental GmbH Claudia Bobrowski
K172689 09/06/2017 DESCRIBE PFD Patch Merz North America, Inc. Misty DÆOttavio
K172655 09/05/2017 Automated ankle brachial pressure index measuring device Mesi D.O.O.; Mesi, Development of medical devices, Ltd. Jakob Susteric
K172848 09/19/2017 MEVION S250i Proton Beam Radiation Therapy Device Mevion Medical Systems Thomas H. Faris
K172786 09/15/2017 MDS Plating System Miami Device Solutions, LLC Michelle Montesino
K172663 09/05/2017 Cytology Brush Micro-Tech (Nanjing) CO., Ltd. Becky Li
K172813 09/18/2017 Esophageal Stent System Micro-Tech (Nanjing) Co.,Ltd. Becky Li
K172880 09/21/2017 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K172672 09/05/2017 Endoscopic Applicator, 41 cm Micromedics Inc. (d/b/a Nordson Medical) Kristi Brezinka
K172881 09/21/2017 NeuroBlate System Monteris Medical David H. Mueller
K172994 09/27/2017 EPI K Console Moria SA Jean-Paul Mercereau
K172764 09/13/2017 Keymill Mycone Dental Supply Company, Inc. (aka Keystone Industries) Priscilla Herpai
K172977 09/27/2017 Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel Nanova Biomaterials Inc Andrew C. Ritts
K173043 09/28/2017 Holycon Synthetic Absorbable Sutures Nantong Holycon Medical Devices Co., Ltd. Feng Lu
DEN170052 09/20/2017 Natural Cycles Natural Cycles Nordic AB Raoul Scherwitzl
K172711 09/08/2017 Comet-PLUS Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K172743 09/12/2017 Natus VikingQuest Natus Neurology Incorporated Shane T. Sawall
K172962 09/26/2017 Nurture Rest Neonatal Loving Kare, Inc. Nicole Sawyers
K173087 09/29/2017 UroLift System (UL400 and UL500) NeoTract, Inc. Louis-Pierre Marcoux
K173082 09/29/2017 ArcoÖ-SA Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K173077 09/29/2017 Cavetto-SA Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K173044 09/28/2017 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Ningbo Albert Novosino Co.,Ltd. Ningbo Albert Novosino
K173029 09/28/2017 Nipro Syringe Nipro Medical Corporation Jessica Oswald-McLeod
K172854 09/20/2017 NobelPerfect Abutments Nobel Biocare AB Charlemagne Chua
K172625 09/01/2017 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor Nonin Medical Inc. Kim E. Aves
K172628 09/01/2017 PRECICE System NuVasive Specialized Orthopedics, Inc. Cora Sim
K173129 09/29/2017 PRECICE System NuVasive Specialized Orthopedics, Inc. Lance Justice
K173117 09/29/2017 NuVasive« VersaTieÖ System NuVasive, Inc. Marysa Loustalot
K172623 09/01/2017 NuVasive Navigation Instruments NuVasive, Incorporated Manthan J. Damani
K172979 09/27/2017 NuVasive« Growth Rod Conversion Set NuVasive, Incorporated Olga Lewis
K173025 09/28/2017 NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System NuVasive, Incorporated Cynthia Adams
K172676 09/05/2017 NuVasive« Modulus-C Interbody System NuVasive, Incorporated Marysa E. Loustalot
K173030 09/28/2017 Vertera Spine Cohere Cervical Interbody Fusion Device NuVasive, Incorporated Michelle Cheung
K173153 09/29/2017 Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System NuVasive, Incorporated Michelle Cheung
K173091 09/29/2017 Boundary Anterior Lumbar Buttress Plate Nvision Biomedical Technologies, LLC Diana L. Langham
K172817 09/18/2017 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA Olympus Medical Systems Corp. Toshiyuki Nakajima
K172726 09/11/2017 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D Olympus Medical Systems Corp. Toshiyuki Nakajima
K172734 09/11/2017 Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp. Toshiyuki Nakajima
K172691 09/06/2017 Ultrasonic Generator OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K172909 09/25/2017 ELEVARE, PERFECTIO 4 Omm Imports d/b/a Zero Gravity Zivan Habibi
K172845 09/19/2017 Symetri Clear Ormco Corporation Tara Bonny
K172696 09/07/2017 FORZA« XP Expandable Spacer System Orthofix Inc. Natalia Volosen
K172699 09/07/2017 Agile Nail Orthofix Srl Gianluca Ricadona
K172698 09/07/2017 G-Beam Fusion Beaming System Orthofix Srl Gianluca Ricadona
K173051 09/28/2017 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl Gianluca Ricadona
K172681 09/06/2017 Edge Air Digital Flat Panel X-ray Detector OSKO, INC. Richard Jeon
K172682 09/06/2017 Edge Digital Flat Panel X-ray Detector Osko, Inc. Richard Jeon
K172906 09/22/2017 REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement OsteoRemedies, LLC Eric Stookey
K172925 09/25/2017 Contact Lens Case, Model: A-1, B-1 P L Overseas Limited Maggie Li
K172777 09/14/2017 Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 PAJUNK GmbH Medizintechnologie Christian G. H. Quass
K172886 09/21/2017 Breakaway Screw System Paragon 28 Eric Lintula
K173032 09/28/2017 Paxman Scalp Cooler Paxman Coolers Limited Richard Paxman
K173012 09/27/2017 ANGIO-PRESS LITE DVT Compression Device Pegasus Medical Supply, Inc. Pao-Ming Shih
K172959 09/26/2017 PeraServer and PeraTrend PeraHealth, Inc. Joseph Beals
K172685 09/06/2017 LiverMultiScan Perspectum Diagnostics Ltd Jaco Jacobs
K173114 09/29/2017 primeMidline Catheters PFM Medical, Inc. Jessica Jho
K172920 09/25/2017 3D APT Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K173079 09/29/2017 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 Philips Medical Systems Nederland B.V. Jan van de Kerkhot
K172822 09/18/2017 Azurion series R1.2 Philips Medical Systems Nederland BV Jeanette Becker
K172904 09/22/2017 IntelliVue Capnography Extension, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K173130 09/29/2017 Reform« Midline Cortical Screw System Precision Spine, Inc. Michael C. Dawson
K172934 09/25/2017 Needle Free Transseptal Cannula Pressure Products Medical Device Manufacturing LLC Andrew Armour
K172893 09/22/2017 SafeSept Needle Free Transseptal Guidewire Pressure Products Medical Device Manufacturing LLC Andrew Armour
K172950 09/26/2017 TSN Transseptal Needle Pressure Products Medical Device Manufacturing LLC Andrew Armour
K173053 09/28/2017 POWDER FREE LATEX EXAMINATION GLOVE Professional Latex Sdn Bhd Yoon Lim Kok
K172859 09/20/2017 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder Prosomnous Sleep Technologies David Kuhns
K172636 09/01/2017 VitaMESH Macroporous PP Surgical Mesh Proxy Biomedical Ltd. Adrienne Tierney
K172790 09/15/2017 ER-REBOA Catheter Prytime Medical Devices, Inc. Brian Young
K173020 09/28/2017 OBA-MCP, Orthodontic Bracket Adhesive with MCP Pulpdent Corporation Kenneth J. Berk
K173002 09/27/2017 2940 nm Er:Yag Laser Handpiece Quanta System S.p.A. Francesco DellÆAntonio
K173102 09/29/2017 Reliance Cervical IBF System Reliance Medical Systems, LLC Bret M. Berry
K172647 09/01/2017 Reprocessed ArthroCare ENT Coblator ReNovo, Inc. Mark K. Wells
K172751 09/12/2017 iVitri Straw Reprobitech Corp. Huai L. Feng
K172875 09/21/2017 Astral 100/150 ResMed Ltd Peter Jennings
K173181 09/29/2017 ExSpiron 1Xi Respiratory Motion Inc. Susan Hamann
K173147 09/29/2017 SuperNO2VA Et Device Revolutionary Medical Devices, Inc. David M. Kane
K172913 09/25/2017 cobas Factor II and Factor V Test Roche Molecular Systems, Inc. Pooja Shah
K172928 09/25/2017 Portable X-ray System Rolence Enterprise Inc. Sterling Cheng
K172627 09/01/2017 David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette Runbio BioTech Co.,Ltd Chandler Chen
K172674 09/05/2017 Sapphire Cervical Implant System Sapphire Medical Group Anthony Ruggiero
K173022 09/28/2017 SeaSpine Ventura NanoMetalene System SeaSpine Orthopedics Corporation Gina Flores
K172926 09/25/2017 SeaSpine Vu cPOD, Zuma-C, Complete Cervical SeaSpine Orthopedics Corporation Gina Flores
K173112 09/29/2017 LAP-iX Sejong Medical Co., Ltd. Yoojung Choi
K173111 09/29/2017 LAP-iX Suction Irrigation Sejong Medical Co., Ltd. Yoojung Choi
K173108 09/29/2017 Smoklean Sejong Medical Co., Ltd. Yoojung Choi
K173156 09/29/2017 Integrated CardioRespiratory System Sensydia, Inc. Thomas Bruggere
K172839 09/19/2017 ENDOSOLV Septodont Jaimie Woodruff
K172761 09/13/2017 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Shanghai New Century Dental Materials Co., Ltd. Charles Shen
K172998 09/27/2017 uWS-MI Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K173000 09/27/2017 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K173169 09/29/2017 Rapid Family SharpLight Technologies Ltd. Ilan Sharon
K172678 09/05/2017 THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE Shen Wei USA Inc. Cheryl Reep
K172694 09/07/2017 Sterile Disposable Syringes Shenyang MasTech Medical Device Co., Ltd. Liu Han
K172969 09/26/2017 Essence 55S Large Monitor System Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing
K172815 09/18/2017 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K172933 09/26/2017 Mini TENS DEVICE (Model: KRES102), TENS &EMS DEVICE (Model: KRES100B) Shenzhen Conree Technology Co.,Ltd Rihua Meng
K172797 09/15/2017 ECG Cable/Leadwires Shenzhen Coreray Technology., Ltd Simon Fan
K173045 09/28/2017 Oximeter Shenzhen Greatmade Tech limited Mei Mei
K173123 09/29/2017 Pulse Oximeter Shenzhen IMDK Medical Technology Co., Ltd. Xia Yuan
K172896 09/22/2017 Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 Shenzhen Jiacom Technology Co ., Ltd Luo Tianfeng
K172894 09/22/2017 Infrared Thermometer Shenzhen Jiacom Technology Co ., Ltd Luo Tianfeng
K172874 09/21/2017 Infrared Thermometer Shenzhen Jiacom Technology Co., Ltd Luo Tianfeng
K172972 09/26/2017 Wrist Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd Luo Tianfeng
K172795 09/15/2017 Infrared Thermometer Shenzhen Jumper Medical Equipment Co., Ltd. Rambo Yang
K172883 09/21/2017 Home Use Hair Removal Device/T1, T2, T3 Shenzhen Mareal Tech Co., Ltd Libin Liu
K172970 09/26/2017 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound ShenZhen Mindray Bio-Medical Electronics Co., Ltd Yang Zhaohui
K172860 09/20/2017 Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Ma Chao
K172889 09/21/2017 Infrared Thermometer Shenzhen Pacom Medical Instruments Co., Ltd. Liangzhou Zhong
K172910 09/25/2017 Emit II Plus Oxycodone Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K173023 09/28/2017 Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold Siemens Medical Solutions USA, Inc. Tabitha Estes
K172832 09/19/2017 Insight BD Siemens Medical Solutions, Inc Denise Adams
K172961 09/26/2017 LIAC HWL Sit Sordina Iort Technologies Spa Alessia Giaffreda
K172688 09/06/2017 Align Radial Head System Skeletal Dynamics, LLC Ana M. Escagedo
K172876 09/21/2017 PowerDot PD-01M Smartmissimo Technologies Pte Ltd Alexey Pisarev
K172785 09/15/2017 CONQUEST FN Smith & Nephew Allison Chan
K172684 09/06/2017 Smith & Nephew, Inc. ANTHOLOGYÖ AFIT Hip Stem Smith & Nephew, Inc. Jonathan DiMotta
K172823 09/18/2017 Portex NRFit Epidural Needles Smiths Medical ASD, Inc. Sunita Teekasingh
K172800 09/18/2017 Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors Smiths Medical ASD, Inc. Michael R. Johnson
K172622 09/01/2017 Microcyn Antimicrobial Skin and Wound Cleanser Sonoma Pharmaceuticals Brian W. Martin
K172851 09/20/2017 Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc. Brian Martin
K173058 09/28/2017 P10 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K172993 09/27/2017 P20 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K172687 09/06/2017 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Stephanie Byrum
K172967 09/26/2017 Mercury« Spinal System Spinal Elements Inc. Julie Lamothe
K173175 09/29/2017 Paramount Anterior Cervical Cage System Spine Wave, Inc. Yvonne Riley-Poku
K172752 09/12/2017 CELERITY 20 HP Biological Indicator Steris Corporation Jennifer Nalepka
K172755 09/12/2017 PRO-LITE Sterilization Trays Steris Corporation Tricia Cregger
K172754 09/12/2017 V-PRO maX 2 Low Temperature Sterilization System Steris Corporation Bill Brodbeck
K172753 09/12/2017 VERIFY VH2O2 Indicator Tape Steris Corporation Bill Brodbeck
K172746 09/12/2017 VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label STERIS Corporation Bill Brodbeck
K172749 09/12/2017 Vis-U-All Low Temperature Sterilization Pouch/Tubing Steris Corporation Tricia Cregger
K172748 09/12/2017 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack STERIS Corporations Jennifer Nalepka
K172644 09/01/2017 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated Elizabeth Greene
K173074 09/29/2017 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor Stryker Jacob Scheenstra
K172921 09/25/2017 Stryker Self-Punching ICONIX Stryker Katie Farraro
K172724 09/11/2017 XIA« 4.5 Spinal System, Power Adaptor Instrument Accessory Stryker Corporation Priyanka Patel
K173135 09/29/2017 VariAx 2 System Stryker GmbH Paul Nelson
K172856 09/20/2017 Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider Stryker Sustainability Solutions Scott English
K172774 09/14/2017 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma Gmbh Heike Gustke
K173004 09/27/2017 SB Soft Hood - Straight type, SB Soft Hood - Undercut type Sumitomo Bakelite Co., Ltd Shiro Agehama
K173110 09/29/2017 GRAFTSITE Summit Medical Ltd. Robyn Cochrane
K172982 09/27/2017 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeff Stanifer
K173021 09/28/2017 Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems Supersonic Imagine Laurence Hermitte
K172978 09/27/2017 SurgeoBite Surgovations LLC Chris Menard
K172666 09/05/2017 CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor SutureEase, Inc. Scott Heneveld
K172975 09/27/2017 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins û MR Conditional, DePuy Synthes Variable Angle Positioning Pins û MR Conditional, DePuy Synthes Wire Mount û MR Conditional, DePuy Synthes Cerclage Positioning Pin û MR Conditional Synthes (USA) Products LLC/DePuy Orthopaedics Inc Suchitra Basu
K172708 09/08/2017 T2Bacteria Panel T2 Biosystems, Inc. Tom Lowery
K172728 09/11/2017 Applanation tonometer AT-1 TAKAGI SEIKO CO., LTD. Shinya Kitamura
K173093 09/29/2017 TAMA BEMS device TAMA Research Corporation Ali Shambayati
K172692 09/06/2017 Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Tangible Science LLC Vic McCray
K172645 09/01/2017 iLux Instrument, iLux Disposable Tear Film Innovations, Inc. John Slate
K172775 09/14/2017 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle Teleflex Medical, Inc. Holly Hallock
K172995 09/27/2017 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation Liang Lu
K172868 09/20/2017 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group Ltd. Kirsty Samuels
K172667 09/05/2017 MagVita TMS Therapy w/MagPro R20 Tonica Elektronik A/S Lise Terkelsen
K172923 09/25/2017 Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue Top Glove Sdn. Bhd. Noor Akilah Binti Saidin
K173119 09/29/2017 DRI OCT Triton Topcon Corporation Charles Reisman
K173090 09/29/2017 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 Toshiba Medical Systems Corporation Paul Biggins
K172863 09/20/2017 Infinix-i, INFX-8000V, V7.0 Toshiba Medical Systems Corporation Paul Biggins
K173088 09/29/2017 Vitrea Software Toshiba Package VSTP-001A Toshiba Medical Systems Corporation Paul Biggins
K172646 09/01/2017 XIDF-AWS801, Angio Workstation, V7.0 Toshiba Medical Systems Corporation Paul Biggins
K172878 09/21/2017 Vantage Titan 3T, MRT-3010/A7, M-Power GX Toshiba Medical Systems Corporation, Japan Paul Biggins
K173104 09/29/2017 Klassic HD« Hooded Acetabular Insert with E-Link« Poly, Klassic HD« Low Profile Acetabular Insert with E-Link« Poly Total Joint Orthopedics, Inc. Chris Weaber
K172720 09/08/2017 TRACOE silcosoft Tracheostomy Tube TRACOE medical GmbH Eva Schaeffer
K173054 09/28/2017 Navigo Workstation Version 2.0 UC-Care Ltd. Hadas Sheynise
K172882 09/21/2017 UINCARE HOME UINCARE Corp. Youngbean You
K173163 09/29/2017 ChlorCid, ChlorCid V, ChlorCid Surf Ultradent Products, Inc. Corey Jaseph
K172833 09/19/2017 E-XPE Acetabular Components and U-Motion II Acetabular Cup United Orthopedic Corporation Gimpel Chien
K172805 09/18/2017 gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc. Carroll L. Martin
K173062 09/28/2017 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) V&Q Manufacturing Corporation Jacky Jin
K172716 09/08/2017 V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Length, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108 Length V2K Medical Inc. Jake Wolenberg
K172951 09/26/2017 Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) Varex Imaging Corporation Catherine Mulcahy
K172675 09/05/2017 Varian Cervical Sleeves Varian Medical Systems, Inc. Peter J. Coronado
K173107 09/29/2017 Vios Central Station Monitor Software, Vios Central Server Software Vios Medical, Inc. Amit Patel
K172747 09/12/2017 HYALURONIC ACID TOPICAL WOUND CREAM VIRCHOW BIOTECH PVT LTD Bruce Gibbins
K173086 09/29/2017 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Visioneering Technologies, Inc. Stephen Snowdy
K172855 09/20/2017 Vitrea Advanced Visualization, Version 7.6 Vital Images, Inc. Katie Ryan
DEN170073 09/29/2017 ContaCT Viz.Al, Inc. Gregory Ramina
K172899 09/22/2017 Vygon PICCs Vygon USA Jillian Mikovich
K172825 09/18/2017 MN-111 W&H Sterilization s.r.l. Marco Parolini
K172809 09/18/2017 OTC Combo TENS/EMS System Well-Life Healthcare Limited Chin-Chih Hsieh
K172794 09/15/2017 Suction Irrigation Set WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Haobin Li
K172665 09/05/2017 Classic Cotton Cannulatome«, CannulaTome II« Double Lumen Sphincterotome, Cotton CannulaTome II« PC, UTS« Ultra Taper Sphincterotome, Tri-Tome pc« Triple Lumen Sphincterotome, Howell D.A.S.H.« Sphincterotome with DomeTip«, Billroth II Sphincterotome, Soeh Wilson-Cook Medical, Inc. / Cook Endoscopy Theresa de Prat
K173013 09/27/2017 WishBone K-Wire System WishBone Medical, Inc. Gary Barnett
K172633 09/01/2017 INFINITY Total Ankle System Wright Medical Technology, Inc. Tara Conrad
K172706 09/07/2017 GammaPod - Model A Xcision Medical Systems, LLC Daniel R. Plonski
K172968 09/26/2017 Hair Up Y&J BIO Co., Ltd. Kwang Sic Kim
K172683 09/06/2017 Yamahachi Pink CAD/CAM Disk Yamahachi Dental Mfg., Co. Shogo Muramatsu
K173078 09/29/2017 Powder-free Clear Vinyl Patient Examination Gloves Yongsheng Medical Products Co., Ltd Jason Wei
K172884 09/21/2017 Arisure Closed Vial Adapter Yukon Medical Todd Korogi
K172631 09/01/2017 Arisure Dry Spike Yukon Medical Todd Korogi
K172983 09/27/2017 HealthCCS Zebra Medical Vision Ltd. Matan Neeman
K172735 09/11/2017 WR19 System Zeto, Inc. Aswin Gunasekar
K172768 09/13/2017 ZOOM Zetta Medical Technologies, LLC. Main M. Ghazal
K172758 09/13/2017 Rotatable Snares, Non-Rotatable Snares Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K172762 09/13/2017 Single Use Hemoclip Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K172763 09/13/2017 Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Zhejiang Kindley medical devices Co.,Ltd Yong Zhang
K173057 09/28/2017 Zimmer Knee Joint Replacement Prostheses MR Labeling Zimmer, Inc. Jason Heckaman
K172767 09/13/2017 Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid Zimmer, Inc. Ehab Esmail
K172653 09/05/2017 Power Infuser ZOLL Medical Corporation Pooja Dalvi


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