FDA 510(k) Decisions During June, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K142770 06/09/2015 Powered Wheelchair AAT ALBER ANTRIEBSTECHNIK GMBH Mrs.Stefanie D Bankston
K150531 06/05/2015 FreeStyle Freedom Lite Blood Glucose Monitoring System Abbott Laboratories Sai Sriharshada Tatavarty
K150332 06/05/2015 FreeStyle Lite Blood Glucose Monitoring System ABBOTT LABORATORIES Sai Sriharshada Tatavarty
K143449 06/26/2015 ADH 200 Analyzer Software ADAMS MEDITECH LLC CECILIA L. YU
K143204 06/03/2015 AOS Clavicle Intramedullary Device ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K150718 06/12/2015 Wi-3 HAL-RAR System AGENCY FOR MEDICAL INNOVATIONS GMBH Stefanie Hoellger
K143397 06/01/2015 ICIS View Agfa HealthCare N.V. JODI COLEMAN
K143604 06/25/2015 Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S BASAK DEMIRCI
K150976 06/04/2015 Collage ANATOMAGE INC. SEAN XU
K150089 06/18/2015 NanoKnife System ANGIODYNAMICS, INC. Suzanne Goodman
K150034 06/09/2015 AMT Enteral Transition Adapters APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA MEINKE
K150625 06/09/2015 Morrison Steerable Needle APRIOMED AB Bruno Edling
K150721 06/17/2015 ARDO Calypso Pro Powered Breast Pump ARDO MEDICAL AG ROGER DUBACH
K150109 06/05/2015 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology Arrow International ( a subsidiary of Teleflex, Inc.) Karl J Nittinger
K151230 06/19/2015 Arthrex FiberTak Anchors Arthrex, Inc. Ivette Galmez
K151103 06/23/2015 ASAHI Corsair Microcatheter ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K150445 06/30/2015 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) ASAHI INTECC CO., LTD. Yoshihiko Fukui
K150140 06/05/2015 MCL 31 Dermablate ASCLEPION LASER TECHNOLOGIES GMBH Antje Katzer
K151211 06/04/2015 AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup Assure Tech. Co., Ltd Eric Lin
K150996 06/17/2015 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC. Brittany Lowe
K142596 06/18/2015 Infusomat Space Volumetric Infusion Pump B. Braun Medical Inc. Gary Johnson
K142577 06/11/2015 PANTHER Endo Linear Cutter Staplers with Single Use Loading Units B.J.Z.H.F. Panther Medical Equipment Co. Ltd. Liu Yu
K150184 06/15/2015 Dymaxeon Spine System Back 2 Basics Direct, LLC Scot Miller
K150709 06/17/2015 ProTrack RF Anchor Wire BAYLIS MEDICAL COMPANY INC. Meghal Khakhar
K151301 06/08/2015 BD Veritor (TM) System for the Rapid Detection of Flu A + B Becton Dickinson and Company Gregory P Payne
K151291 06/10/2015 BD Veritor (TM) System for the Rapid Detection of Flu A+B BECTON DICKINSON AND COMPANY GREGORY P PAYNE
K150591 06/30/2015 Besmed Reusable Jet Nebulizer BESMED HEALTH BUSINESS CORP. WINNIE CHUNG
K143715 06/05/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Better Plastic Co., Ltd. Du Wei
K143524 06/02/2015 Fiber Disks and Blocks (TRINIA) Bicon, LLC Richard Wu
K142814 06/25/2015 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial BIOMET MANUFACTURING LLC TRACY BICKEL JOHNSON
K151224 06/30/2015 Lineum OCT Spine System BIOMET SPINE Spencer Kimber
K150867 06/10/2015 Affixus Tibial Nailing System BIOMET, INC. SUZANA OTANO
K143387 06/03/2015 GE333 Blood Glucose Monitoring System Bionime Coporation Tino Lee
K143110 06/24/2015 GALAXY MIS Screw System BM KOREA JUNE HAN
K150781 06/19/2015 Tissue Removal Pouch BOEHRINGER LABORATORIES, LLC Chris Radl
K150186 06/05/2015 Chariot Guiding Sheath BOSTON SCIENTIFIC CORP. KURTIS HUNSBERGER
K150303 06/15/2015 XXL Vascular Balloon Dilatation Catheter BOSTON SCIENTIFIC CORP. Melanie Raska
K151253 06/10/2015 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter BOSTON SCIENTIFIC LIMITED LISA MEE
K150951 06/25/2015 aeris Balloon Dialation Catheter Bryan Medical , Inc. ANDY BLACK
K143559 06/11/2015 XP1000 RF BTL INDUSTRIES, INC Jan Zarsky
K150569 06/10/2015 LaparoVue Buffalo Filter, LLC Pamela Netzel
K143380 06/05/2015 Phasix ST Mesh C. R. Bard Inc Tony John
K150667 06/17/2015 True Dilatation Balloon Valvuloplasty Catheter C.R. Bard, Inc. Aaron Conovaloff
K150578 06/09/2015 Capillus 272 Office Pro Capillus, LLC Patricia Schnoor
K151116 06/26/2015 CapLOX II/TowerLOX Pedicle Screw System CAPTIVA SPINE TAMALA WAMPLER
K143432 06/03/2015 Cardio-TriTest CARDIO-PHOENIX INC. MARC BISNAIRE
K151260 06/10/2015 ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD Cardiovascular System, Inc. Kim Wallner
K150766 06/24/2015 Carestream DRX-1 System Carestream Health, Inc. Carolyn L Wagner
K150320 06/30/2015 COMPASS CENTERVUE SPA ROBERTO GABRIOTTI
K150643 06/08/2015 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti CENTINEL SPINE, INC. MR. JOHN PARRY
K150053 06/24/2015 STALIF C; STALIF C-Ti Centinel Spine, Inc. John Parry
K142751 06/15/2015 Chang Gung ComMed Series Dental Implant System Chang Gung Medical Technology Co., Ltd. Chao-Chun Chiu
K143002 06/05/2015 Metallic Locking Bone Plate and Screw System Changzhou Dingjian Medical Appliance Co., Ltd Li Qingsong
K150042 06/02/2015 PleuraFlow System ClearFlow, Inc. Dov Gal
K150319 06/12/2015 MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS CODMAN & SHURTLEFF, INC. Hannah Foley
K150218 06/23/2015 Fill-Up! COLTENE/WHALEDENT AG SILKE WALLASCHEK
K150616 06/12/2015 Trevo XP ProVue Retriever (4x30mm) Concentric Medical, Inc. Rhoda M. Santos
K150041 06/26/2015 CORA (Coagulation Resonance Analysis) System Coramed Technologies, LLC Norman E Brunner
K142934 06/17/2015 CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved COVIDIEN Deborah Fleetham
K151356 06/18/2015 Spacemaker Pro Access and Dissector System Covidien LLC Rebecca Magnanimo
K150012 06/04/2015 CreoDent Solidex Customized Abutment CREODENT PROSTHETICS, LTD. CALVIN SHIM
K143520 06/09/2015 SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) CROSSTEX Michael G Nolan
K150920 06/17/2015 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K142679 06/12/2015 CARESCAPE R860 Datex-Ohmeda, Inc. Trishia Dwyer
K150535 06/16/2015 Cavitron Touch Ultrasonic Scaling System DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K151240 06/09/2015 extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Devon Medical Products JOHN SIEGEL
K150696 06/23/2015 Jade 37% Phosphoric Acid Etchant Gel Dharma Research, Inc. Ricardo Carles
K151509 06/25/2015 GSI TympStar Pro Middle Ear Analyzer Diagnostic Group, dba Grason-Stadler Ron Rolfsen
K150879 06/22/2015 LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers DiaSorin Inc. John Walter
K143071 06/26/2015 Nacera Pearl DOCERAM MEDICAL CERAMICS GMBH Stefan Drude
K150076 06/02/2015 Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L DONG IL TECHNOLOGY LTD. DONG BUM KIM
K151281 06/30/2015 AGE Automatic Wrist Blood Pressure Monitor DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD VICTOR WAN
K151485 06/30/2015 GENESIS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K150327 06/29/2015 Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 Dunamis LLC Prithviraj Chavan
K150518 06/29/2015 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm DUPACO INC. AN VU
K150949 06/03/2015 FibroScan ECHOSENS CELINE FOURNIER
K150882 06/16/2015 Edwards Suture Fastening System EDWARDS LIFESCIENCES, LLC. NINA BROOKE
K150074 06/19/2015 Elevate Moisturizing Spray ELEVATE ORAL CARE STEVE PARDUE
K151131 06/19/2015 PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated Rebecca Shelburne
K150029 06/24/2015 Habib EUS RFA EMCISION, LTD. FRANCOIS POULIN
K142794 06/02/2015 Everyway Facial MENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K150761 06/05/2015 Ez3D-i/E3 EWOO SOFT CO., LTD Young Seok Kim
K143484 06/29/2015 BioZorb Marker FOCAL THERAPEUTICS George Hermann
K143570 06/04/2015 WIRION GARDIA MEDICAL OHAD HAAS
K151028 06/18/2015 LOGIQ e GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K143726 06/19/2015 XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING GOH
K143438 06/23/2015 Flowtron ACS900 Getinge (Suzhou) Co., Ltd Lenda Hou
K150552 06/04/2015 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS GLOBUS MEDICAL INC. Kelly J. Baker
K150373 06/11/2015 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K150113 06/18/2015 Fusion Black Powder-Free Nitrile Exam Glove Halyard Health Christine L Macauley
K150593 06/09/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN BHD KUAN KAM HON
K142783 06/12/2015 HEARTWAY Electrically Powered Wheelchair P27 HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K150340 06/18/2015 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD Shaozhang Nan
K150119 06/17/2015 PALACOS R pro HERAEUS MEDICAL GMBH ASTRID MARX
K151132 06/01/2015 PROBEAT-V Hitachi, Ltd.,Health Care Company Naoya Nishimura
K143093 06/24/2015 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., Eric Ankerud, JD
K143437 06/25/2015 Droplet Pen Needles HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska
K150925 06/29/2015 Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set Immunalysis Corporation Joseph Ginete
K151203 06/05/2015 Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set IMMUNALYSIS CORPORATION JOSEPH GINETE
K150414 06/12/2015 Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL INDUSTRIAL CLOTHINGS (PVT) LTD S.N. HARI
K150500 06/19/2015 Px PEEK IBF System INNOVASIS, INC. Marshall McCarty
K143003 06/18/2015 iPulse Smooth Skin Gold Hair Removal System Ipulse Limited Mike Kiernan
K143513 06/19/2015 ZIO SR ECG Monitoring Service iRhythm Technologies, Inc. Rich Laguna
K150393 06/09/2015 TETRIC EVOFLOW BULK FILL IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K143730 06/10/2015 GBR System JEIL MEDICAL CORPORATION HYEROUNG LEE
K142833 06/04/2015 INTRAGen JEISYS MEDICAL, INC. Kyung Won Hwang
K142797 06/18/2015 I.V. Catheter Jiangxi Sanxin Medtec Co., Ltd Bingrong Liu
K150758 06/18/2015 Safety Disposable Insulin Syringe JIANGYIN CAINA TECHNOLOGY CO., LTD JUN LU
K151246 06/30/2015 Aneroid Sphygmomanometer Jiaxing Zhongfa Medical Products Co., Ltd. Mao Xiaohua
K150199 06/15/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K142920 06/10/2015 KM Needles (Acupuncture Needle) K.M.S. INC. CHUL HUI KIM
K151465 06/29/2015 AeroDR SYSTEM 2 KONICA MINOLTA, INC. SHIGEYUKI KOJIMA
K151060 06/05/2015 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Shigeyuki Kojima
K151221 06/23/2015 Kubtec DIGIVIEW 395 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K151244 06/11/2015 Pre-Formed Guidewire Lake Region Medical Mathew Pexa
K142645 06/11/2015 Avenue T TLIF Cage LDR SPINE USA INC. BRADLEY W. STRASSER
K151331 06/30/2015 The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch LUMENIS LTD ELISSA BURG
K143086 06/01/2015 VX120 Ophthalmic Diagnostic Device LUNEAU SAS Isabelle Durand
K150466 06/08/2015 ZX2 Laser System LZR7, Inc Randy Rinkleib
K150548 06/11/2015 Tek RMD (Tek Robotic Mobilization Device) MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN ve TIC.A.S Necati Hacikadiroglu
K150680 06/26/2015 Freedom Cementless Femoral Component MAXX ORTHOPEDICS, INC. Gabriela Gottlieb
K142906 06/09/2015 APTUS Wrist 2.5 System MEDARTIS AG Andrea Schweizer
K142626 06/12/2015 Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters MEDELA, AG Orlando Antunes
K142548 06/23/2015 MIDSLEEVE MEDICAL INNOVATION DEVELOPMENT Melanie Fouilland
K151001 06/05/2015 MUSE System MEDIGUS LTD. YANIV SAGIE
K150216 06/11/2015 Synergy Cranial MEDTRONIC NAVIGATION, INC. KAYE E. WAITE
K150231 06/16/2015 Navigated Disc Prep Instruments and CAPSTONE Trials MEDTRONIC SOFAMOR DANEK USA, INC Nicholas Tabrizi
K150135 06/11/2015 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K142559 06/09/2015 ELEVATE Spinal System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K142835 06/12/2015 Iliad Pedicle Screw System and Zenius Pedicle Screw System MEDYSSEY USA, INC. JOHN KUCZYNSKI
K150257 06/19/2015 PreludeEASE Hydrophilic Sheath Introducer Merit Medical Systems, Inc. Michaela Rivkowich
K142912 06/23/2015 Merits Yoga Power Scooter, S542 MERITS HEALTH PRODUCTS CO., LTD. Vincent Chen
K150434 06/02/2015 Injection Needle Micro-Tech (Nanjing) CO., Ltd. Becky Li
K143020 06/23/2015 LiverMultiScan MIRADA MEDICAL LTD. Gwilym Owen
K150419 06/19/2015 miraDry System MD4000 MIRAMAR LABS, INC. KATHY O'SHAUGHNESSY
K150574 06/30/2015 Modular Power Positioning System MOTION CONCEPTS Dona Bhamra
K143622 06/17/2015 dynaMX Compression Staple MX Orthopedics, Corp. Howard L. Schrayer
K151238 06/12/2015 JUSHA-M23C LCD Monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD Ma Jing
K150623 06/18/2015 Nanova Flowable Composite NANOVA BIOMATERIALS, INC. Andrew Ritts
K143041 06/04/2015 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter Natec Medical Ltd Xavier De Buchere
K150562 06/02/2015 Safe'n'Sound Staked Passive Delivery System - Plajex version Nemera James A WERKAMP
K142834 06/23/2015 DiscoverEEG System, Model DE-401 NeuroWave Systems Inc. Tatjana Zikov
K150378 06/12/2015 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook NICO Corporation Sean Spence
K150363 06/29/2015 NOVA Dental Implants System NOVA Implants Ltd. Dan Grimberg
K151272 06/23/2015 Henschke Titanium Applicator Set NUCLETRON B.V. Lizette Van de Streek
K151214 06/25/2015 ALIF Interfixated System NuVasive, Incorporated Cynthia Adams
K150362 06/11/2015 NuVasive CoRoent Small Interbody System NuVasive, Incorporated Martin Yahiro
K150994 06/17/2015 NuVasive CoRoent Thoracolumbar Implants NUVASIVE, INCORPORATED CYNTHIA ADAMS
K150472 06/04/2015 NxStage System One NXSTAGE MEDICAL, INC. Mary Lou Stroumbos
K143590 06/04/2015 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES Brian W Martin
K142786 06/23/2015 Ontex Unscented Tampons with Colored Plastic Applicators ONTEX BVBA Henri Lesage
K142830 06/25/2015 Ophthalmed Bending Laser Probes OPHTHALMED LLC JAY MANSOUR
K142598 06/12/2015 Opto Wire and OptoMonitor System Opsens, Inc. Vanessa Mootoosamy
K142595 06/04/2015 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II ORTHO CLINICAL DIAGNOSTICS Bradley P Boyer
K150294 06/05/2015 DPZ Pedicular Fixation System Osteomed Implantes, LTDA J. D. Webb
K143572 06/10/2015 Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK Osteomed Implantes, LTDA Niderdani Ragonha
K150415 06/12/2015 NilRead Perceptive Software Claudio Gatti
K150975 06/25/2015 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Michael Asmalsky
K150581 06/04/2015 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K150851 06/04/2015 Sure Lok Mini Posterior Cervical/Upper Thoracic System PRECISION SPINE, INC. Michael Dawson
K150494 06/27/2015 Proteus Digital Health Feedback Device PROTEUS DIGITAL HEALTH, INC. Jessie Duong
K143474 06/30/2015 Artemis Hand Held Imaging System QUEST MEDICAL IMAGING MARTIN HEUVELMANS
K150868 06/23/2015 Solana GAS Assay, Solana instrument QUIDEL CORPORATION RONALD H LOLLAR
K150719 06/16/2015 OARtrac System with Skin Sensors RadiaDyne, LLC John K. Isham
K142898 06/17/2015 ABL800 FLEX with AQURE connectivity Radiometer Medical Aps. Lasse Post Moller
K143671 06/19/2015 Propeller Model 2014-D Sensor Reciprocal Labs David Hubanks
K143466 06/08/2015 Hemogrip Patch REMEDIUM TECHNOLOGIES, INC. JOHN GUSTIN
K150266 06/04/2015 Remington Medical Inc. Tuohy Epidural Needles REMINGTON MEDICAL, INC. CAITLIN SENTER
K150496 06/12/2015 Total Knee Arthroplasty System Responsive Orthopedics LLC Doug Kohrs
K150443 06/04/2015 ToeTac Hammertoe Fixation System RESTORE SURGICAL LLC dba Instratek JEFF SEAVEY
K143476 06/23/2015 Digi-One RIMED LTD. AHAVA STEIN
K150910 06/03/2015 ACCU-CHEK Connect Diabetes Management App ROCHE DIABETES CARE INC. CHUNHONG TAO
K150617 06/01/2015 cobas HSV 1 and 2 Test ROCHE MOLECULAR SYSTEMS, INC. DAVID W. GATES
K143335 06/01/2015 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) Roosin Medical Devices Co., Ltd Chengyu Shen
K151082 06/07/2015 MicroCross Catheter ROXWOOD MEDICAL, INC. GRACE LI
K143411 06/29/2015 TRAUS ENDO SAESHIN PRECISION CO., LTD. Sae Kwan Choi
K151419 06/23/2015 GF50A SAMSUNG ELECTRONICS CO., LTD. Chulsin Kim
K150280 06/11/2015 PulmoVia Working Channel SANOVAS, INC. Roy Morgan
K150002 06/23/2015 iNSIGHT Color Doppler Ultrasound System SASET (CHENGDU) INC. Dong Chyuan Liu
K143398 06/26/2015 Plato MICROCATH 27B Microcatheter SCIENTIA VASCULAR , LLC Sharon Rockwell
K150549 06/01/2015 Reactor(TM) Trocar and Sleeve Sharp Medical Prducts, LLC Chris Salvino
K150093 06/03/2015 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 SHENZHEN CREATIVE INDUSTRY CO., LTD. JIA WANG
K150080 06/12/2015 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Zhai Pei
K150167 06/30/2015 V60 Anesthetic Vaporizer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TANG HO
K151192 06/23/2015 syngo.via MI Workflows SIEMENS MEDICAL SOLUTIONS USA, INC VERONICA PADHARIA
K150493 06/30/2015 Sensis Siemens Medical Solutions, Inc. Patricia D Jones
K150512 06/17/2015 STAR 90 SKANRAY TECHNOLOGIES PVT LTD. Hema ` Singh
K150939 06/08/2015 Ensizor Endoscopic Scissors SLATER ENDOSCOPY, LLC JOHN STARKEY
K150981 06/23/2015 SMV Scientific Bone Screws SMV Scientific Nephi Zufelt
K150369 06/18/2015 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, Somn SOMNOMED INC. KIEN T. NGUYEN
K150376 06/12/2015 Sonoma Cancellous Bone Screw and Washer Sonoma Orthopedics Products, Inc Rick Epstein
K150489 06/11/2015 EOS PMP, EOS PMP Integrated SORIN GROUP ITALIA S.R.L. LUIGI VECCHI
K150895 06/19/2015 SPEC Model M16 Source Production and Equipment Co.,Inc. Kelly Richardt
K151215 06/03/2015 Mercury Spinal System Spinal Elements Inc. JULIE LAMOTHE
K150312 06/17/2015 Vdrive system, Vdrive Duo, Vdrive with V-Sono STEREOTAXIS, INC. JOHN NADELIN
K150250 06/11/2015 SternSnap Angled Attachment Sterngold Dental, LLC MARIA RAO
K150517 06/05/2015 Freedom Spinal Cord Stimulator System STIMWAVE TECHNOLOGIES INCORPORATED Elizabeth Greene
K151201 06/29/2015 Stryker ICONIX with Needles Stryker TAYLOR WHITE
K151387 06/24/2015 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade STRYKER JONATHAN SCHELL
K150753 06/09/2015 OASYS System STRYKER CORPORATION Garry T Hayeck
K150582 06/12/2015 Vertaplex« High Viscosity (HV) Radiopaque Bone Cement STRYKER CORPORATION KRISTI ASHTON
K150538 06/25/2015 Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider STRYKER SUSTAINABILITY SOLUTIONS SCOTT ENGLISH
K151178 06/24/2015 VariAx 2 Wrist Fusion System Stryker Trauma AG DR. HEIKE GUSTKE
K150540 06/22/2015 Instru-Safe Instrument Protection System SUMMIT MEDICAL, INC. Nicole Dove
K150559 06/19/2015 Life Fast Set, Life Regular Set SYBRON DENTAL SPECIALTIES Kerri Casino
K150796 06/23/2015 Dental Bone Cutting Instruments SYNTHES (USA) PRODUCTS, LLC SUSAN LEWANDOWSKI
K151276 06/18/2015 DePuy Synthes T-PAL Ti Spacer SYNTHES USA PRODUCTS LLC Eric Zhu
K143090 06/15/2015 LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID TALLADIUM, INC. ELINA FASKHUTDINOVA
K151161 06/24/2015 VICTUS Femtosecond Laser Platform TECHNOLAS PERFECT VISION GMBH FRIEDRICH MORITZ
K143581 06/26/2015 Arrow Epidural Catheter Kit Teleflex Medical, Inc. Angela Bouse
K151398 06/25/2015 K-Pack II Needle - 29G x 5/16 Thin Wall TERUMO EUROPE N.V. M. J. Aerts
K150783 06/23/2015 Progressive Orthopaedic Total Knee System The Progressive Orthopaedic Company, LLC Scott Keiser
K150727 06/17/2015 ESTECEM TOKUYAMA DENTAL CORPORATION Fumio Takahashi
K150967 06/18/2015 XIDF-AWS801, Angio Workstation, V6.10 Toshiba Medical Systems Corporation Paul Biggins
K150570 06/03/2015 ANAX OCT Spinal System U&I Corporation Young-Geun Kim
K150666 06/22/2015 uNion Cervical Plate System ulrich medical USA Hans Stover
K150725 06/08/2015 Visaris Avanse VISARIS d.o.o. Belgrade Milan Ratkovic
K150018 06/17/2015 VS3-IR-MMS System Visionsense Ltd. Alex Chanin
K142750 06/26/2015 JiveX VISUS TECHNOLOGY TRANSFER GMBH Axel Schreiber
K151115 06/03/2015 MR Core Software Vital Images, Inc Parthiv Shah
K142642 06/30/2015 Vitalograph Model 6600 Compact VITALOGRAPH(IRELAND) LTD. Tom J Healy
K142812 06/29/2015 Vitalograph Model 6800 Pneumotrac VITALOGRAPH(IRELAND) LTD. Tom J Healy
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