FDA 510(k) Decisions During August, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K151369 08/07/2015 .decimal p.d .DECIMAL, LLC KEVIN ERHART
K151687 08/03/2015 QuantorView 3DISC AMERICAS SIGRID SMITT-JEPPESEN
K143613 08/14/2015 PaxWire Occlusion Balloon System ACCESSCLOSURE, INC. Kelly Jabbal
K151056 08/13/2015 Aesculap T-Space PEEK and XP Spinal System AESCULAP IMPLANT SYSTEMS, LLC LISA M. BOYLE
K143729 08/18/2015 SterilContainer S AESCULAP, INC. Denise R Adams
K151935 08/12/2015 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only ALERE SAN DIEGO, INCORPORATED JOSEPH DE LA ROSA
K143354 08/20/2015 Natrelle 133 Plus Tissue Expander ALLERGAN, INC. Bruce Krattenmaker
K150395 08/10/2015 Omega LIF System AMENDIA, INC. Bruce Hooper
K150043 08/14/2015 Transcutaneous Electrical Nerve Stimulators (TENS) ANDON HEALTH CO.,LTD Liu Yi
K142689 08/06/2015 GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System Apex BioTechnology Corp. Hsue-mei Lee
K151153 08/20/2015 Pirouette 018 ARRAVASC LIMITED MAIREAD MCCAFFREY
K151877 08/07/2015 MicroTract Access System ARSTASIS, INC. Debra Cogan
K151256 08/12/2015 Arthrex BioSync« Bone Wedge Arthex, Inc Laura Medlin
K150648 08/20/2015 Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm ARTHREX, INC. Laura Medlin
K151732 08/28/2015 Arthrex Fracture Plates ARTHREX, INC. COURTNEY SMITH
K151897 08/06/2015 MultiFIX« P Knotless Fixation Device ArthroCare Corporation Laura Kasperowicz
K151459 08/31/2015 Integra Total Ankle Replacement System Ascension Orthopedics Frederic Testa
K151437 08/27/2015 ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug ATRIUM MEDICAL CORPORATION TIMOTHY J. TALCOTT
K151998 08/19/2015 TraceIT Tissue Marker - 3mL AUGMENIX, INC. NOEL ROLON
K150621 08/18/2015 OsteoSelect PLUS Demineralized Bone Matrix Putty BACTERIN INTERNATIONAL INC. Howard L Schrayer
K143538 08/14/2015 MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit BAYER MEDICAL CARE INC. LISA A. EWING
K151009 08/18/2015 Nexus Suture BAYLIS MEDICAL COMPANY INC. Meghal Khakhar
K143648 08/25/2015 BD MAX Enteric Parasite Panel, BD MAX Instrument BECTON, DICKINSON AND COMPANY PAUL SWIFT
K151206 08/28/2015 Fingertip Pulse Oximeter BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K151219 08/04/2015 Models 2200DR and 1600DR Digital Stationary Radiographic Systems BEIJING POLYCON MEDICAL ENGINEERING COMPANY XIANGCHEN LIU
K151064 08/12/2015 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System BIOMET SPINE Alexandra Beck
K151409 08/07/2015 Selectra Catheters and Selectra Accessory Kit BIOTRONIK, INC. JON BRUMBAUGH
K143292 08/04/2015 TheraCal DC Bisco Inc Michelle Schiltz-Taing
K151801 08/13/2015 Arc Endocuff Vision BODDINGTONS PLASTICS LTD PAUL BLACKMORE
K150692 08/05/2015 AXIOS Stent with Electrocautery Enhanced Delivery System BOSTON SCIENTIFIC CORP. Carole Sykes
K151802 08/06/2015 Resolution Clip BOSTON SCIENTIFIC CORPORATION ELENA NIEVES
K151325 08/04/2015 Bovie J-Plasma Handpiece BOVIE MEDICAL CORPORATION Brian Kunst
K142943 08/03/2015 Metallic Locking Bone Plate and Screw Canwell Medical Co., Ltd Chen Hui
K151516 08/21/2015 Capillus82 Capillus, LLC PATRICIA SCHNOOR
K150289 08/27/2015 CARDIOLINE S.p.A. CARDIOLINE S.p.A Emanuele Ercoli
K150810 08/14/2015 Vyntus / SentrySuite Product Line CareFusion Germany 234 GmbH Elmar Niedermeyer
K150929 08/04/2015 CareView 1500Cw X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. YULING DING
K151057 08/10/2015 WASTON Metallic Bone Plate and Screw Systems CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD Jack Lu
K143758 08/07/2015 PerioType Rapid CLINICAL HOUSE EUROPE GMBH Judi Weissinger
K151379 08/13/2015 Conventus PRS System Conventus Orthopaedics, Inc Kent R Lind
K152033 08/19/2015 Cook ECM Powder Cook Biotech Incorporated Perry W Guinn
K152044 08/14/2015 Flexor Radial Hydrophilic Introducer Access Set COOK INCORPORATED SARAH REEVES
K150847 08/13/2015 Foundation Interbody Devices CORELINK LLC Sharon Gregory
K150735 08/04/2015 Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot COVIDIEN NANCY SAUER
K151088 08/28/2015 DMRC Bulk Fill DANVILLE MATERIALS, LLC DONG HUA
K150040 08/27/2015 Implanova DENTAL EVOLUTIONS INC. PARSA T ZADEH
K151867 08/07/2015 STA R MAX DIAGNOSTICA STAGO S.A.S. ARNAUD COLLIN
K151006 08/31/2015 EarlySense Central Display Station (CDS) EARLYSENSE LTD. DALIA ARGAMAN
K150220 08/19/2015 STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast EB NEURO, S.P.A. Christiano Pineider
K150823 08/26/2015 EDLENi Intra-Oral Sensor EDLEN IMAGING LLC Nick Radachi
K143325 08/20/2015 OC-Light S FIT EIKEN CHEMICAL CO. LTD Yoshinori Ota
K151319 08/28/2015 Eko Electronic Stethoscope System Eko Devices, Inc. Connor Landgraf
K151561 08/04/2015 Leksell Gamma Knife Icon ELEKTA INSTRUMENT AB MATILDA FORSBERG
K151200 08/13/2015 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device ETHICON, INC. DONNA MARSHALL
K151061 08/06/2015 Cornea Cold EUROBIO Marie-Claude Amoureux
K152070 08/26/2015 BioZorb LP Marker Focal Terapeutics George Hermann
K150962 08/28/2015 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack FOCUS DIAGNOSTICS SHARON YOUNG
K151346 08/20/2015 Frontier Medical Devices Posterior Cable Screw System FRONTIER MEDICAL DEVICES, INC. BETHANY BYMAN
K143556 08/20/2015 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T FUJIFILM MEDICAL SYSTEMS U.S.A., INC. MARY MOORE
K151859 08/12/2015 Synapse Cardiovascular FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K152209 08/19/2015 FUJIFILM SonoSite X-Porte Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K143721 08/27/2015 PRCT2 FX SOLUTIONS JEAN JACQUES MARTIN
K152133 08/28/2015 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System GALIL MEDICAL LTD LYNNE DAVIES
K151372 08/14/2015 Low Dose CT Lung Cancer Screening Option for Qualified GE Systems GE Medical Systems, LLC John Jaeckle
K151587 08/07/2015 Digital Automatic Wrist Blood Pressure Monitor MD3200 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K151583 08/07/2015 Digital Automatic Wrist Blood Pressure Monitor MD3900 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K150767 08/17/2015 EDOSE GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC DENNIS DONG
K150022 08/07/2015 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K150519 08/19/2015 ManipulatOR PRO, ManipulatOR GYNETECH PTY. LTD. Brett Telford
K143539 08/31/2015 Dental Implant OKTAGON Bone Level Hager & Meisinger GmbH Wiebke Stolten
K150857 08/14/2015 Banana Gold HANKOOK LATEX GONGUP CO., LTD. KWON DUKEE
K151463 08/18/2015 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components HANSEN MEDICAL, INC. Elisa Aldridge
K151343 08/24/2015 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) HARTALEGA NGC SDN BHD KUAN MUN LEONG
K151642 08/13/2015 Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K151348 08/18/2015 Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC JIANQIU FANG
K150311 08/18/2015 Full Automatic (NIBP)Blood Pressure Monitor Health & Life Co., Ltd. Sarah Su
K152186 08/20/2015 HealthMyne PACS HEALTHMYNE, INC. SIGRID SCHOEPEL
K150695 08/13/2015 Modpod HOLLYWOG, LLC MICHAEL TREAS
K150169 08/14/2015 Sertera Biopsy Device Hologic, INC Brenda Geary
K151164 08/07/2015 Assure Prism multi Blood Glucose Monitoring System i-Sens, Inc. JOON HO JUNG
K151232 08/06/2015 VIKINI Diode Laser System ILOODA CO., LTD Suhee Nam
K151740 08/27/2015 JAZZ System Implanet, S.A. Regis Le Couedic
K152097 08/25/2015 Retraction Aspirator INARI MEDICAL EBEN GORDON
K150274 08/26/2015 GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System Infopia Co., Ltd. NA YUN KIM
K143738 08/27/2015 DSS Sinusplasty Balloon Catheter Intuit Medical Products, LLC Jack Griffis
K151591 08/18/2015 Angel pedicle screw spinal system JIANGSU ANGEL MEDICAL INSTRUMENT CO., LTD SHENG XIANG MA
K150971 08/25/2015 Zekang Self-adhesive Electrode Jiangsu Zekang Medical Technology Co., Ltd Doris Dong
K142760 08/25/2015 Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles K.S. Choi Corporation Kak Soo Choi
K151216 08/10/2015 Everest Spinal System K2M, Inc Nancy Giezen
K150481 08/20/2015 Cascadia Interbody System K2M, Inc. Nancy Giezen
K150865 08/03/2015 Metacross RX PTA Balloon Dilitation Catheter Kaneka Corporation Toshihiko Motomine
K150771 08/27/2015 RxG Distraction System KLS MARTIN L.P. JENNIFER DAMATO
K150703 08/13/2015 CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K150704 08/21/2015 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Pa KURARAY NORITAKE DENTAL, INC. MICHIO TAKIGAWA
K143487 08/21/2015 Lifelines iEEG KVIKNA EHF Gardar Thorvardsson
K151140 08/18/2015 LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd Yerim An
K143017 08/07/2015 Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver LABORATOIRES URGO SOPHIE FORTIN
K151702 08/13/2015 Reusable Full Silicone Cover LAERDAL MEDICAL AS MARI KAADA
K151333 08/21/2015 LightStim for Pain LED Belt LED INTELLECTUAL PROPERTIES, LLC Steve Marchese
K143454 08/27/2015 Pruitt F3-S Carotid Shunt LeMaitre Vascular, Inc Xiang Zhang
K151286 08/05/2015 OPTIS Integrated System Mobile Workstation LIGHTLAB IMAGING, INC. Padmini Suravaram
K151947 08/12/2015 LightSheer Desire Light Laser System LUMENIS LTD ELISSA BURG
K143752 08/06/2015 Total Knee Application (TKA) MAKO SURGICAL CORP. JONATHAN REEVES
K150928 08/10/2015 Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides MATERIALISE N.V. Laurel Berzanskis
K151850 08/11/2015 McKesson Cardiology MCKESSON ISRAEL LTD. GILBERT WONG
K151023 08/05/2015 COMPACT PIEZO LED MECTRON SPA FRANCO ZUNINO
K150986 08/17/2015 Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants MEDDEV CORPORATION PATRICK GREY
K151117 08/20/2015 Laparoscope Lens Shield Device Medeon Biodesign, Inc Greta Chang
K151235 08/06/2015 Medline Foot Plates and Screws MEDLINE INDUSTRIES, INC. Jennifer Mason
K143529 08/21/2015 UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer MEDLINE INDUSTRIES, INC. JENNIFER MASON
K150465 08/03/2015 Medtronic Confida Brecker Guidewire Medtronic CoreValve, LLC. Genevieve Balutowski Dunbar
K151000 08/06/2015 O-Arm O2 Imaging System MEDTRONIC INC. RISHI SINHA
K150614 08/06/2015 Reveal LINQ MEDTRONIC INC. DIANNA L. JOHANNSON
K151128 08/06/2015 CAPSTONE Spinal System, CLYDESDALE Spinal System MEDTRONIC SOFAMOR DANEK USA, INC LEE GRANT
K151172 08/14/2015 MASTERGRAFT Contain MEDTRONIC SOFAMOR DANEK USA, INC Gregory K Maschek
K150728 08/14/2015 XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole MEDTRONIC XOMED, INC. Gabriela Anchonda
K152054 08/07/2015 Confida Adaptive Sheath Medtronic, Inc. Matthew Lobeck
K143203 08/26/2015 AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe MEDWAVES INCORPORATED TED ORMSBY
K151768 08/28/2015 Menicon Saline Rinse Solution MENICON CO.,LTD. TOHRU KAWAGUCHI
K143583 08/11/2015 Cathivex ?GV filter units MERCK MILLIPORE LTD. CHRIS PARR
K152116 08/27/2015 5.5 F Worley Advanced LVI Lateral Vein Introducer MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K151373 08/07/2015 Corvocet Coaxial Introducer Merit Medical Systems, Inc. Ileana Garcia
K151776 08/12/2015 Central Venous Pressure System Mespere LifeSciences Inc. Helen Tan
K143348 08/21/2015 BC-3600 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Tan Chuanbin
K143233 08/13/2015 Mitsar-EEG MITSAR CO., LTD Semchenkov Ales
K150146 08/31/2015 Biogel PI Micro Indicator Underglove MOLNLYCKE HEALTH CARE US, LLC Megan Bevill
K150205 08/24/2015 LED Curing Light MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K143433 08/28/2015 Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm Natus Manufacturing Limited Michael Galvin
K143458 08/13/2015 Neurosplint Neurospectrum LLC David Kernan
K151797 08/25/2015 Nuocande Plastic Manual Wheelchair Model NKD L07 NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. CHARLES SHEN
K151305 08/27/2015 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) NONIN MEDICAL INC. LAURA J. LIND
K151341 08/20/2015 Turbo High-Flow Non-coring Needle NORFOLK MEDICAL NATAN PHEIL
K151407 08/12/2015 RECON system NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K152071 08/26/2015 NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) NOVABONE PRODUCTS, LLC RICHARD A. DAVIS
K151277 08/13/2015 Airlock« osteosynthesis plate system NOVASTEP GILLES AUDIC
K150143 08/31/2015 Normal Saline Flush NURSE ASSIST, INC. Brian Cox
K151374 08/06/2015 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System NuVasive, Incorporated Olga Lewis
K143579 08/28/2015 NuVasive Sterilization Trays NuVasive, Incorporated Olga Lewis
K150786 08/27/2015 Rezum System NxThera, Inc. J. Robert Paulson, JD
K150398 08/06/2015 EUM 100Pro OB TOOLS, LTD. GAL BEN DAVID
K151623 08/06/2015 Penumbra System 110 Aspiration Tubing Penumbra, Inc. Michaela Mahl
K151929 08/12/2015 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORPORATION DARI DARABBEIGI
K151598 08/17/2015 VesselNavigator Rel. 1.0 PHILIPS MEDICAL SYSTEMS NEDERLAND BV LISELOTTE KORNMANN
K150665 08/07/2015 Philips Spectral CT Applications PHILIPS MEDICAL SYSTEMS NETHRLANDS BV NONE PROVIDED
K151863 08/07/2015 Precision Spine Interspinous Plate System PRECISION SPINE, INC. MICHAEL C. DAWSON
K151422 08/21/2015 Reform Pedicle Screw System Precision Spine, Inc. Michael C. Dawson
K151753 08/27/2015 16 ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC Kathleen Aras
K151924 08/07/2015 Q-Rad Radiographic System with Auto-Tracker Option QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM MARK CAMIRAND
K150819 08/06/2015 Triglycerides Randox Laboratories Limited Pauline Armstrong
K151880 08/07/2015 Wingman Crossing Catheter REFLOW MEDICAL REBECCA K PINE
K143623 08/13/2015 Narval Brux RESMED SAS Larissa D'Andrea
K150572 08/27/2015 Respire Pink Series-Herbst-EF Respire Medical Holding David Walton
K150288 08/28/2015 PDO Absorbable Punctum Plug RIVERPOINT MEDICAL Edwin Anderson
K143446 08/13/2015 Accu-Chek FlexLink Plus infusion set Roche Diagnostics GmbH Alexander Ruegner
K143534 08/06/2015 Elecsys CA-125 II assay ROCHE PROFESSIONAL DIAGNOSTICS LINDA MCCAMMACK
K151756 08/21/2015 STERISPINE LC CAGE SAFE ORTHOPAEDICS Pierre Dumouchel
K143700 08/05/2015 CPAP Cannulaide Salter Labs Aurelia Brownridge
K151663 08/12/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KYEONG-MI PAK
K151180 08/19/2015 ScandiDos Delta4 Phantom+ SCANDIDOS AB THOMAS MATZEN
K151856 08/06/2015 ABL80 FLEX CO-OX with AQURE connectivity SENDX MEDICAL INC. Vibeke Agerlin
K150095 08/06/2015 ReDs Wearable System SENSIBLE MEDICAL INNOVATIONS LTD. Inbal Ben-Tzvi
K150894 08/28/2015 VIA 21 Microcatheter SEQUENT MEDICAL, INC Bethany Barrett
K142976 08/26/2015 UltraTENS Shenzhen Dongdixin Technology Co., Ltd Qilian Liu
K151653 08/07/2015 8ch Foot Ankle Coil SHENZHEN RFTECH CO., LTD. KE XI
K151462 08/12/2015 SI-TECHNOLOGY« SI-DESIS« SCREWS SI-TECHNOLOGY, LLC CHRIS DONNER
K150757 08/11/2015 syngo.CT Dual Energy SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
K150745 08/11/2015 syngo.CT Single Source Dual Energy Siemens Medical Solutions USA, Inc. Kimberly Mangum
K151353 08/07/2015 syngo.MR Neurology, syngo.MR Oncology SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151380 08/13/2015 syngo.via RT Image Suite SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K150685 08/24/2015 Skynector CPAP Mask SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. Field Fu
K143512 08/26/2015 ActiSpec Activity Monitor SLEEP MODUS, INC. STANFORD P HUDSON
K152164 08/28/2015 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152165 08/26/2015 S9 Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K142995 08/17/2015 SOPIX SOPRO - ACTEON GROUP PHILIPPE BOYER
K150564 08/12/2015 Spaulding Electrocardiograph 2100iQ Spaulding Clinical Research, LLC Andre Leak
K151741 08/20/2015 HA Minuteman G3 MIS Fusion Plate SPINAL SIMPLICITY LLC JULIE MCKEE
K152174 08/31/2015 Sniper Spine System SPINE WAVE, INC. Sanja Jahr
K150357 08/27/2015 Reprocessed Electrophysiology Diagnostic Catheters STERILMED, INC. Nicole Boser
K151247 08/10/2015 NC Straumann Screw Retained Abutments STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K151157 08/05/2015 NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K150814 08/10/2015 Straumann Screw-Retained Abutment STRAUMANN USA, LLC Manuela Ventur
K152076 08/26/2015 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker Jonathan Schell
K150584 08/13/2015 Stryker Suture Tape Stryker Taylor White
K151243 08/20/2015 STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] Stryker Endoscopy GOLNAZ MOEINI
K151879 08/06/2015 VariAx 2 One-Third Tubular Plating System STRYKER GMBH HEIKE GUSTKE
K151264 08/10/2015 Restoration Anatomic Shell STRYKER ORTHOPAEDICS Allison M Ling
K150452 08/13/2015 ComboCath OTW PTA Dilatation Catheter Summa Therapeutics, LLC Richard Rush
K151166 08/18/2015 Instru-Safe Instrument Protection System Summit Medical Inc. Nicole Dove
K151332 08/17/2015 Nexus Universal, Nexus Universal Chroma SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K151241 08/07/2015 Synchro-Medical TIGER TRACK Screw System Synchro Medical Danilo Campani
K143444 08/21/2015 SynePure Wound Cleanser Synedgen Inc. Shenda Baker
K150673 08/21/2015 SYNFIX Evolution Secured Spacer System SYNTHES (USA) PRODUCTS LLC EUGENE BANG
K143692 08/21/2015 GranOSTM - beta tricalcium phosphate synthetic bone granules TCM ASSOCIATES LTD IAIN ALLIGAN
K152081 08/26/2015 Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflex Medical, Inc. Ashlea Ricci
K150973 08/04/2015 NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs TERANG NUSA SND BHD ROBERT HILL
K151349 08/27/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation John Chesney
K150412 08/28/2015 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group Ltd Marianne Sender
K150658 08/26/2015 Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit THE BINDING SITE GROUP LTD Andrea Thomas
K150556 08/28/2015 Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K142765 08/11/2015 TM SAFETY NEEDLE ThinkMed Medical Technology Co., Ltd. Garfield Wang
K150871 08/04/2015 ForeFoot STP System TORNIER, INC. BRIAN HOCKETT
K151837 08/19/2015 CS 3D Imaging TROPHY MARIE-PIERRE LABAT-CAMY
K151087 08/21/2015 CS 8100SC, CS8100SC Access TROPHY MARIE-PIERRE LABAT-CAMY
K150086 08/05/2015 Titan TZORA ACTIVE SYSTEMS LTD. Adi Shemer
K151371 08/19/2015 Corporate Dental Imaging (CDI) Application U.S. ARMY DENTAL COMMAND (DENCOM) WILLIAM K. PORTER
K151213 08/21/2015 UCP Drug Test Mini Cups UCP BIOSCIENCES, INC NANCY CHEN
K150432 08/14/2015 IDODENTINE DISC, IDODENTINE BLOCK UNION DENTAL S.A. JOSE LUIS RODRIGUEZ BLANCO
K151316 08/13/2015 U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation Karen Ho
K151345 08/25/2015 BioGuard Air/Water Valve, BioGuard Suction Valve UNITED STATES ENDOSCOPY GROUP, INC. CARROLL L. MARTIN
K143424 08/28/2015 UTAH CVX-RIPE UTAH MEDICAL PRODUCTS, INC. Ben Shirley
K151533 08/13/2015 Respiratory Gating for Scanners VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151657 08/07/2015 Shielded Applicator Set, Cervical Stop VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151981 08/13/2015 Turnpike catheter VASCULAR SOLUTION, INC. BEKA VITE
K143554 08/04/2015 Venus Legacy CX Venus Concept Ltd. Orit Ron Edoute
K150154 08/28/2015 ANAM Test System: Military Battery Vista LifeSciences, Inc. Lori White
K143701 08/26/2015 EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM VOLCANO CORPORATION MARCUS GARCIA
K151961 08/18/2015 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens Volk Optical Inc. Meghan M Leonard
K151008 08/26/2015 LINK« MEGASYSTEM-C« Waldemar Link GmbH & Co. KG Helmut D Link
K143148 08/11/2015 Disposable Pressure Manometer (DPM) Westmed, Inc. DIANA UPP
K151142 08/13/2015 IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID WIELAND DENTAL + TECHNIK GMBH & CO. KG BETINA KISTNER
K143724 08/27/2015 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit WILLIAM A. COOK AUSTRALIA PTY, LTD. Gordana Pozvek
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