FDA 510(k) Applications Received During March, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K150547 03/03/2015 .decimal Astroid Dosimetry App .decimal, inc KEVIN ERHART
K150622 03/11/2015 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M Company Hilary B. Hovde
K150694 03/18/2015 3M Comply Hydrogen Peroxide Indicator Tape 1228 3M Company Hilary B. Hovde
K150531 03/02/2015 FreeStyle Freedom Lite Blood Glucose Monitoring System Abbott Laboratories Sai Sriharshada Tatavarty
K150544 03/03/2015 Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System AESCULAP IMPLANT SYSTEMS, LLC Julie Tom Wing
K150718 03/19/2015 Wi-3 HAL-RAR System AGENCY FOR MEDICAL INNOVATIONS GMBH Stefanie Hoellger
K150660 03/13/2015 Alcyone MEMS Cannula (AMC) System ALCYONE LIFESCIENCES, INC. ELSA CHI ABRUZZO
K150773 03/24/2015 E-CUBE 15 Diagnostic Ultrasound System ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K150625 03/11/2015 Morrison Steerable Needle APRIOMED AB Bruno Edling
K150721 03/19/2015 ARDO Calypso Pro Powered Breast Pump ARDO MEDICAL AG ROGER DUBACH
K150648 03/12/2015 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
K150621 03/11/2015 OsteoSelect PLUS Demineralized Bone Matrix Putty BACTERIN INTERNATIONAL INC. Howard L Schrayer
K150821 03/27/2015 MDNG-3220 (Nio 3MP LED) Barco Lieven De Wandel
K150709 03/19/2015 ProTrack RF Anchor Wire BAYLIS MEDICAL COMPANY INC. Meghal Khakhar
K150591 03/09/2015 Besmed Reusable Jet Nebulizer BESMED HEALTH BUSINESS CORP. WINNIE CHUNG
K150768 03/24/2015 JuggerKnot Soft Anchors BIOMET MANUFACTURING CORP. ADAM CARGILL
K150522 03/02/2015 G7 Dual Mobility System BIOMET, INC. Amy Walriven
K150850 03/31/2015 Refobacin Bone Cement R BIOMET, INC. CARMEN ALBANY
K150781 03/25/2015 Tissue Removal Pouch BOEHRINGER LABORATORIES, LLC Chris Radl
K150692 03/18/2015 AXIOS Stent with Electrocautery Enhanced Delivery System BOSTON SCIENTIFIC CORP. Carole Sykes
K150679 03/17/2015 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector BOSTON SCIENTIFIC CORP. Virginia Garcia
K150720 03/19/2015 XP3000 BTL Industries, Inc. Jan Zarsky
K150569 03/06/2015 LaparoVue Buffalo Filter, LLC Pamela Netzel
K150529 03/02/2015 Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System C.R. Bard, Inc Reily Inman
K150699 03/18/2015 Bard LubriGuard Foley Catheter C.R. Bard, Inc. Michele Davis
K150667 03/16/2015 True Dilatation Balloon Valvuloplasty Catheter C.R. Bard, Inc. Aaron Conovaloff
K150578 03/09/2015 Capillus 272 Office Pro Capillus, LLC Patricia Schnoor
K150579 03/09/2015 Cardinal Health External Fixation System CARDINAL HEALTH TATYANA BOGDAN
K150732 03/20/2015 Diamondback 360 Peripheral Orbital Atherectomy System CARDIOVASCULAR SYSTEMS, INC. Blair Buth
K150810 03/26/2015 Vyntus / SentrySuite Product Line CareFusion Germany 234 GmbH Elmar Niedermeyer
K150766 03/24/2015 Carestream DRX-1 System Carestream Health, Inc. Carolyn L Wagner
K150620 03/10/2015 740 SELECT CAS MEDICAL SYSTEMS, INC. Ron Jeffrey
K150643 03/12/2015 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti CENTINEL SPINE, INC. MR. JOHN PARRY
K150661 03/13/2015 ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite CITIEFFE s.r.l Stefano Pullega
K150573 03/06/2015 ebb Complete Tamponade System CLINICAL INNOVATIONS, LLC Tom Haueter
K150555 03/04/2015 BA400 14mm Abutment COCHLEAR AMERICAS Tristan Manus
K150751 03/23/2015 Cordelle II Sound Processor COCHLEAR AMERICAS Laura Blair
K150798 03/26/2015 Codent Low Speed Dental Handpieces and Accessories CODENT TECHNICAL INDUSTRY CO., LTD. Chin-Ting Wen
K150615 03/10/2015 Vaginal Moisturizing Gel COMBE INCORPORATED Pushpa Rao
K150616 03/10/2015 Trevo XP ProVue Retriever (4x30mm) Concentric Medical, Inc. Rhoda M. Santos
K150590 03/09/2015 CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, CONTAMAC LTD Rob McGregor
K150594 03/09/2015 Biodesign Otologic Repair Graft COOK BIOTECH INCORPRATED PERRY W. GUINN
K150802 03/26/2015 Heavy Double Flexible Tipped Wire Guide COOK INCORPORATED JULIA FERGUSON
K150733 03/20/2015 Vital-Port Vascular Access System Power Injectable Port COOK INCORPORATED STEVEN LAWRIE
K150836 03/30/2015 OUTBACK Elite Re-Entry Catheter CORDIS CORPORATION, A JOHNSON & JOHNSON CO. MICHELLE RAGOZZINO RODGERS
K150847 03/31/2015 Foundation Interbody Devices CORELINK LLC Sharon Gregory
K150778 03/25/2015 Various Brands of Ultraviolet Lamps COSMEDICO LIGHT, INC. Steven Schlitt
K150852 03/31/2015 SIC 8000 COSMO TECHNOLOGIES, LTD. RICHARD JONES
K150735 03/20/2015 Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot COVIDIEN NANCY SAUER
K150844 03/30/2015 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula COVIDIEN Danielle Mueller
K150724 03/20/2015 SculpSure CYNOSURE, INC. KEVIN O'CONNELL
K150587 03/09/2015 Cortex Laser System Cynosure, Inc. dba Ellman Allison Sathe
K150759 03/23/2015 Hyper-C Anterior Cervical Plate System Degen Medical Craig Black
K150535 03/03/2015 Cavitron Touch Ultrasonic Scaling System DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K150696 03/18/2015 Jade 37% Phosphoric Acid Etchant Gel Dharma Research, Inc. Ricardo Carles
K150518 03/02/2015 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm DUPACO INC. AN VU
K150823 03/27/2015 EDLENi Intra-Oral Sensor EDLEN IMAGING LLC Nick Radachi
K150516 03/02/2015 DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS EL.EN ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K150656 03/13/2015 PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated Rebecca Shelburne
K150840 03/30/2015 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier ETHICON ENDO-SURGERY, LLC Marjorie Medina
K150670 03/16/2015 STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, INC. DONNA MARSHALL
K150761 03/23/2015 Ez3D-i/E3 EWOO SOFT CO., LTD Young Seok Kim
K150681 03/17/2015 GEMORE OTC TENS GEMORE TECHNOLOGY CO., LTD. Boden S.P Lai
K150649 03/12/2015 G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. MICHAEL BOTTLANG,
K150812 03/26/2015 Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine Dave Lamb
K150552 03/04/2015 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS GLOBUS MEDICAL INC. Kelly J. Baker
K150752 03/23/2015 GME ExSys 308 GME (GERMAN MEDICAL ENGINEERING) GMBH STEFAN SCHULZE
K150767 03/24/2015 EDOSE GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC DENNIS DONG
K150602 03/10/2015 CR3 Keyless Split Sample Cup Morphine - Methamphetamine GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K150519 03/02/2015 ManipulatOR PRO, ManipulatOR GYNETECH PTY. LTD. Brett Telford
K150857 03/31/2015 Banana Gold HANKOOK LATEX GONGUP CO., LTD. KWON DUKEE
K150593 03/09/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA SDN BHD KUAN KAM HON
K150791 03/25/2015 Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC JIANQIU FANG
K150756 03/23/2015 Micro well group culture dish, 9-well; Micro well group culture dish, 16-well HERTART MICHAEL TRINKLE
K150565 03/06/2015 Supria Whole-body X-ray CT System HITACHI MEDICAL SYSTEMS AMERICA, INC. Doug Thistlethwaite
K150695 03/18/2015 Modpod HOLLYWOG, LLC MICHAEL TREAS
K150813 03/27/2015 iTClamp50 INNOVATIVE TRAUMA CARE INC Ian Atkinson
K150707 03/19/2015 IntelePACS INTELERAD MEDICAL SYSTEMS INCORPORATED Ms. Luce Caron
K150837 03/30/2015 IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps INTUITIVE SURGICAL, INC. SARAH RIZK
K150758 03/23/2015 Safety Disposable Insulin Syringe JIANGYIN CAINA TECHNOLOGY CO., LTD JUN LU
K150532 03/02/2015 Universal Light Handle Cover, Light Handle Cover Key Surgical, Inc. Amy Yanta
K150771 03/24/2015 RxG Distraction System KLS MARTIN L.P. JENNIFER DAMATO
K150703 03/18/2015 CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K150704 03/18/2015 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
K150765 03/24/2015 LDR Spine ROI-C Cervical Cage System LDR SPINE USA Brad Strasser
K150712 03/19/2015 LTM-Perforated Surgical Mesh LifeCell Corporation Linda Scamardella
K150747 03/23/2015 EzDent-i /E2/Prora View LK Consulting Group USA, Inc. Priscilla Chung
K150691 03/18/2015 Datalys Multi-Parameter Patient Monitor Lutech Industries, Inc. RONALD VACHULA
K150548 03/03/2015 Tek RMD (Tek Robotic Mobilization Device) MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN ve TIC.A.S Necati Hacikadiroglu
K150680 03/17/2015 Freedom Cementless Femoral Component MAXX ORTHOPEDICS, INC. Gabriela Gottlieb
K150776 03/24/2015 Medrobotics Flex System MEDROBOTICS CORPORATION JOHN D BONASERA
K150611 03/10/2015 MedSource ClearSafe Safety IV Catheter MedSource International Laura Riggen
K150614 03/10/2015 Reveal LINQ MEDTRONIC INC. DIANNA L. JOHANNSON
K150728 03/20/2015 XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole MEDTRONIC XOMED, INC. Gabriela Anchonda
K150530 03/02/2015 Level Sensor, Level Sensor Tape Medtronic, Inc Rahul Shah
K150567 03/06/2015 MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic, Inc. Bruce Backlund
K150537 03/03/2015 MiNi Internal Implant System MEGAGEN IMPLANT CO., LTD Dong Guk Ha
K150777 03/25/2015 Artoura Breast Tissue Expander MENTOR WORLDWIDE LLC Manchi Cheung
K150657 03/13/2015 Phoenix XL Dialysate Meter Mesa Laboratories, Inc. Jamie Louie
K150779 03/25/2015 LipoFilter - Hospital Pack, LipoFilter - Clinic Pack MICROAIRE SURGICAL INSTRUMENTS, LLC Chris Spofford
K150705 03/18/2015 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator Minimally Invasive Devices, Inc. Trudie L Seeger
K150574 03/06/2015 Modular Power Positioning System MOTION CONCEPTS Dona Bhamra
K150746 03/23/2015 JUSHA-M52C Medical Display NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MA JING
K150842 03/30/2015 JUSHA-M53 Medical Display NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JING MA
K150623 03/11/2015 Nanova Flowable Composite NANOVA BIOMATERIALS, INC. Andrew Ritts
K150527 03/02/2015 Xcela Power Injectable PICC NAVILYST MEDICAL, INC. Wanda Carpinella
K150562 03/06/2015 Safe'n'Sound Staked Passive Delivery System - Plajex version Nemera James A WERKAMP
K150772 03/24/2015 Snap-Off Self-Compressive Screw NEOSTEO JD Webb
K150647 03/12/2015 Polyscrew Pedicle Screw System New Era Orthopedics, LLC Mark De Baca
K150742 03/23/2015 Muscle Stimulation System 110 NIVEUS MEDICAL, INC. Brian Fahey
K150786 03/25/2015 Rezum System NxThera, Inc. J. Robert Paulson, JD
K150633 03/11/2015 ULTRA Telescopes OLYMPUS WINTER & IBE GMBH KATHARINA SCHNACKENBURG
K150619 03/10/2015 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Orthofix Inc. Natalia Volosen
K150822 03/27/2015 Centurion POCT System ORTHOFIX, INC. JACKI GEREN
K150655 03/13/2015 OIC Intramedullary Nail System ORTHOPAEDIC IMPLANT COMPANY Douglas Fulton
K150600 03/10/2015 Response 5.5/6.0 Spine System ORTHOPEDIATRICS CORP. MARK FOX
K150663 03/16/2015 Diagnostic X-ray System OSKO, INC. WANG CHOI
K150607 03/10/2015 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml OSSEON LLC Keith Burger
K150665 03/16/2015 Philips Spectral CT Applications PHILIPS MEDICAL SYSTEMS NETHRLANDS BV NONE PROVIDED
K150581 03/09/2015 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K150856 03/31/2015 Reform Pedicle Screw System PRECISION SPINE, INC. Michael Dawson
K150851 03/31/2015 Sure Lok Mini Posterior Cervical/Upper Thoracic System PRECISION SPINE, INC. Michael Dawson
K150601 03/10/2015 Zeramic Adhesive Resin Cement Premier Dental Company Products VINCENT D'ALESSANDRO
K150719 03/19/2015 OARtrac System with Skin Sensors RadiaDyne, LLC John K. Isham
K150819 03/27/2015 Triglycerides Randox Laboratories Limited Pauline Armstrong
K150654 03/13/2015 Cholesterol RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K150563 03/06/2015 Marrow Cellution Bone Marrow Aspiration Needle RANFAC CORP CHRISTOPHER P. WHELAN
K150627 03/11/2015 Rapid Aid Instant Disposable Infant Heel Warmer RAPID AID CORP. Rose Ren
K150797 03/26/2015 Digital Dental Intra Oral Sensor, EzSensor Smart Rayence Co., Ltd Kevin Kim
K150572 03/06/2015 Respire Pink Series-Herbst-EF Respire Medical Holding David Walton
K150639 03/11/2015 AF541 EE Full Face Mask RESPIRONICS, INC. Shaylee Masilunas
K150638 03/11/2015 AF541 SE Full Face Mask Respironics, Inc. Shaylee Masilunas
K150617 03/10/2015 cobas HSV 1 and 2 Test ROCHE MOLECULAR SYSTEMS, INC. DAVID W. GATES
K150521 03/02/2015 Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System RTI SURGICAL, INC. dba RTI BIOLOGICS Jennifer Bonacci
K150754 03/23/2015 ARGOS SANTEC CORPORATION CHANGHO CHONG
K150545 03/03/2015 Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K150816 03/27/2015 Jumong Series SG HEALTHCARE CO LTD YOSEP PARK
K150549 03/03/2015 Reactor(TM) Trocar and Sleeve Sharp Medical Prducts, LLC Chris Salvino
K150632 03/11/2015 Hypervisor IX Monitoring System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K150714 03/19/2015 SI-BONE iFuse Implant System SI-BONE, Inc. Roxanne Dubois
K150843 03/30/2015 syngo«.via (version VB10A) Siemens AG Martin Meyer
K150785 03/25/2015 syngo.CT Dental SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K150757 03/23/2015 syngo.CT Dual Energy SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
K150745 03/23/2015 syngo.CT Single Source Dual Energy Siemens Medical Solutions USA, Inc. Kimberly Mangum
K150750 03/23/2015 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray Sirona Dental Systems GMBH Thomas Diesch
K150675 03/16/2015 Dorsal Spanning Plate SKELETAL DYNAMICS, LLC ANN M. ESCAGEDO
K150685 03/17/2015 Skynector CPAP Mask SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. Field Fu
K150564 03/06/2015 Spaulding Electrocardiograph 2100iQ Spaulding Clinical Research, LLC Andre Leak
K150634 03/11/2015 AngioSculpt PTA Scoring Baloon Catheters Spectranetrics Kimberley Kline
K150631 03/11/2015 St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter St. Jude Medical Harlan Jones
K150517 03/02/2015 Freedom Spinal Cord Stimulator System STIMWAVE TECHNOLOGIES INCORPORATED Elizabeth Greene
K150814 03/27/2015 Straumann Screw-Retained Abutment STRAUMANN USA, LLC Manuela Ventur
K150584 03/09/2015 Stryker Suture Tape Stryker Taylor White
K150700 03/18/2015 ACP 1 Anterior Cervical Plating System STRYKER CORPORATION Tina Mornak
K150539 03/03/2015 OASYS System Stryker Corporation GARRY T. HAYECK
K150753 03/23/2015 OASYS System STRYKER CORPORATION Garry T Hayeck
K150801 03/26/2015 Stryker Maestro Air Motors STRYKER CORPORATION DEVAL PATEL
K150582 03/09/2015 Vertaplex« High Viscosity (HV) Radiopaque Bone Cement STRYKER CORPORATION KRISTI ASHTON
K150538 03/03/2015 Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider STRYKER SUSTAINABILITY SOLUTIONS SCOTT ENGLISH
K150540 03/03/2015 Instru-Safe Instrument Protection System SUMMIT MEDICAL, INC. Nicole Dove
K150848 03/31/2015 Dose Calculator SUN NUCLEAR CORPORATION JAMES LUKER
K150559 03/06/2015 Life Fast Set, Life Regular Set SYBRON DENTAL SPECIALTIES Kerri Casino
K150673 03/16/2015 SYNFIX Evolution Secured Spacer System SYNTHES (USA) PRODUCTS LLC EUGENE BANG
K150796 03/26/2015 Dental Bone Cutting Instruments SYNTHES (USA) PRODUCTS, LLC SUSAN LEWANDOWSKI
K150533 03/02/2015 Terason uSmart3200T Ultrasound System TERATECH CORP. Steven R Broadstone
K150536 03/03/2015 Terumo Circuit Tubing Terumo Cardiovascular Systems Corporation Garry Courtney
K150542 03/03/2015 Terumo Pump Tubing TERUMO CARDIOVASCULAR SYSTEMS CORPORTION JOSHUA EWING
K150576 03/06/2015 TGM Biolox delta Ceramic Heads TGM MEDICAL, INC. Gordon Smith
K150658 03/13/2015 Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit THE BINDING SITE GROUP LTD Andrea Thomas
K150526 03/02/2015 Optilite IgG4 Kit THE BINDING SITE GROUP LTD Andrea Thomas
K150783 03/25/2015 Progressive Orthopaedic Total Knee System The Progressive Orthopaedic Company, LLC Scott Keiser
K150556 03/04/2015 Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K150727 03/20/2015 ESTECEM TOKUYAMA DENTAL CORPORATION Fumio Takahashi
K150641 03/11/2015 MagVita TMS Therapy System TONICA ELEKTRONIK A/S Lise Terkelsen
K150715 03/19/2015 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors TORNIER, INC. Kaitlyn Rainbow
K150583 03/09/2015 Aequalis PerFORM+ Shoulder System TORNIER, INC. Kris Miller
K150613 03/10/2015 LaserCap LC Pro and LC Elite TRANSDERMAL CAP, INC. MICHAEL RABIN
K150570 03/06/2015 ANAX OCT Spinal System U&I Corporation Young-Geun Kim
K150650 03/12/2015 neon3 ULRICH GMBH & CO. KG Christoph Ulrich
K150666 03/16/2015 uNion Cervical Plate System ulrich medical USA Hans Stover
K150832 03/30/2015 U2 Femoral Component, CR, Porous Coated, Additional Sizes UNITED ORTHOPEDIC CORPORATION FANG-YUAN HO
K150829 03/30/2015 U2 Total Knee System- Additional Sizes UNITED ORTHOPEDIC CORPORATION Fang-Yuan Ho
K150839 03/30/2015 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K150636 03/11/2015 VariSeed 9.0 VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K150706 03/18/2015 VitalBeam VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K150628 03/11/2015 VentriPoint Medical System VENTRIPOINT, INC. JIM BODTKE
K150725 03/20/2015 Visaris Avanse VISARIS d.o.o. Belgrade Milan Ratkovic
K150738 03/20/2015 VitreaView Vital Images, Inc PARTHIV SHAH
K150784 03/25/2015 Admira Fusion VOCO GMBH M TH PLAUMANN
K150551 03/04/2015 GORE SEAMGUARD Reinforcement W. L. GORE & ASSOCIATES, INC. BARBARA L. SMITH
K150580 03/09/2015 UltraVision 2 Diagnostic Ultrasound System WINPROBE CORPORATION ROSE MALCHOW
K150520 03/02/2015 DARCO Locking Bone Plate System WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K150834 03/30/2015 Atrax Anterior Cervical Plating System X-Spine Systems, Inc David Kirschman
K150662 03/13/2015 Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) YPSOMED AG Stephen Affolter
K150630 03/11/2015 Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear YUNG SHENG OPTICAL CO., LTD. Wen-Han Chen
K150730 03/20/2015 Zimmer PSI Shoulder System ZIMMER CHRISTOPHER MCLEAN
K150626 03/11/2015 Rush Medullary Pins Zimmer, Inc. Patrick McCullagh
K150818 03/27/2015 Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System ZIMMER, INC. PATRICK MCCULLAGH


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact