FDA 510(k) Decisions During March, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K142402 03/23/2015 BigEasy Non-Rebreathing Valve 12th Man Technologies, Inc. Alex Stenzler
K143207 03/23/2015 Revitive IX (OTC) Actegy, Ltd Angela Glover
K133789 03/04/2015 DOLPHIN NEUROSTIM OTC ACUMED MEDICAL LTD. RICHARD KEEN
K143443 03/25/2015 VEGA Knee System, Columbus Total Knee System Aesculap Implants Systems, LLC Julie Tom Wing
K143114 03/10/2015 Sense4Baby System Model B+ (MSA) AIRSTRIP TECHNOLOGIES, INC. ROBERT ANDREW MILLER
K141757 03/31/2015 ALERE I STREP A ALERE SCARBOROUGH, INC Angela Drysdale
K141237 03/13/2015 HARMONY LITE ALMA INC. KATHY MAYNOR
K143580 03/18/2015 PeriCoach ANALYTICA LTD GEOFF DALY
K142983 03/04/2015 AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating ANGIOSCORE, INC. Kimberley Kline
K143517 03/27/2015 Voyant Open Sealer-Divider Device APPLIED MEDICAL RESOURCES Jessica Cho
K141159 03/11/2015 KONUS DENTAL IMPLANT SYSTEM ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH LINDA SAYLOR
K141981 03/09/2015 ASAHI FUBUKI 043 / ASAHI FUBUKI ASAHI INTECC CO., LTD. CANDACE CEDERMAN
K143519 03/10/2015 The MeDioStar NeXT Family ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K141536 03/06/2015 VIEWING CLIENT MOBILE AXON MEDICAL TECHNOLOGIES CORP. CHAS YU
K140943 03/05/2015 MASTRO PLUS BALLOON IN-DEFLATION DEVICE BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. MIKE GU
K143492 03/04/2015 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA Judith Clerc
K142332 03/20/2015 BT-400 Bio-Med USA Young Chi
K143379 03/13/2015 Liquichek Maternal Serum II Control Bio-Rad Laboratories Elizabeth Platt
K142448 03/24/2015 VARIANT II TURBO HbA1c Kit - 2.0 Bio-Rad Laboratories, Inc. Jackie Buckley
K141975 03/05/2015 WATERLASE IPLUS S BIOLASE, INC. COLLEEN BOSWELL
K142174 03/20/2015 BIOMATE DENTAL IMPLANT SYSTEM BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. WAYNE CHEN
K143697 03/30/2015 Biomet Proximal Humerus Plating System Biomet Manufacturing Julie Largent
K142634 03/12/2015 Biomet Spine Fusion System BIOMET SPINE, LLC. Mike Medina
K150503 03/25/2015 Echo Bi-Metric Microplasty Line Extension BIOMET, INC. AMY WALRIVEN
K143503 03/19/2015 BioMonitor BIOTRONIK, INC. JON BRUMBAUGH
K142337 03/19/2015 Blackford Analysis Registration Product Family BLACKFORD ANALYSIS LTD Gordon McNeilly
K143668 03/20/2015 Navio BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K142677 03/27/2015 MALDI Biotyper CA System BRUKER DALTONICS, INC Ken Hirakawa
K141785 03/31/2015 MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES BSD MEDICAL CORP. DIXIE TOOLSON SELLS
K143109 03/06/2015 XP300 BTL INDUSTRIES, INC Jan Zarsky
K142818 03/31/2015 Phasix Mesh C.R. Bard Steve Keenan
K142706 03/25/2015 Modified ONFLEX Mesh C.R. Bard Inc. Mariya Buharin
K142711 03/20/2015 ONFLEX Mesh C.R. Bard Inc. Mariya Buharin
K150529 03/30/2015 Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System C.R. Bard, Inc Reily Inman
K142873 03/12/2015 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners C.R.Bard Inc. Christine Lloyd
K142916 03/04/2015 SVED Wound Treatment System CARDINAL HEALTH Tatyana Bogdan
K142990 03/04/2015 Insta-Gard Surgical and Procedure Face Mask Cardinal Health 200, LLC Lavenia Ford
K142959 03/20/2015 Vyntus Walk CAREFUSION GERMANY 234 GMBH Elmar Niedermeyer
K141837 03/11/2015 DRX-EVOLUTION CARESTREAM HEALTH,INC. CAROLYN L WAGNER
K143473 03/25/2015 Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles CAYENNE MEDICAL, INC Shima Hashemian
K150573 03/25/2015 ebb Complete Tamponade System CLINICAL INNOVATIONS, LLC Tom Haueter
K142907 03/25/2015 Baha 5 Sound Processor COCHLEAR AMERICAS Sean Bundy
K142464 03/05/2015 Entriport CONMED CORPORATION Anna D'Lima
K143725 03/04/2015 Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc Matthew M Hills
K141322 03/27/2015 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER COOK INCORPORATED STEVEN LAWRIE
K133788 03/18/2015 COOK HOLMIUM LASER FIBER COOK INCORPORATED DAVID CHADWICK
K142294 03/26/2015 FlexiMarc Marker CORTEX MANUFACTURING, INC. Andrew Jones
K143100 03/05/2015 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta Cossington Ltd Diana Mandell Horwitz, Ph.D.,RAC
K143134 03/05/2015 NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System Cossington Ltd Diana Mandell Horwitz
K141518 03/05/2015 Nellcor Bedside Respiratory Patient Monitoring System COVIDIEN JAMIE THOMAS
K143598 03/12/2015 Lapro-Clip Auto Suture Reusable Long Clip Applier Covidien LLC Rebecca Magnanimo
K142865 03/26/2015 Nellcor Bedside SpO2 Patient Monitoring System Covidien LLC Megan Fessenden
K142808 03/09/2015 CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners CR BARD INC Andrew Harrell
K142545 03/20/2015 SonoFlow Sonohysterography and Sonohysterosalpingography Device CrossBay Medical, Inc. Piush Vidyarthi
K142886 03/18/2015 DMRC Self-Cure Bracket Adhesive One Step and Primer DANVILLE MATERIALS, LLC. Dong Hua
K142531 03/20/2015 F1-Modular Pedicle Screw System Degen Medical Craig Black
K150196 03/26/2015 DD cubeX2 DENTAL DIREKT GMBH UWE GREITENS
K141385 03/27/2015 DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON JEFFREY DOW
K150375 03/11/2015 LIAISON VZV IgG, LIAISON Control VZV IgG DiaSorin Inc. John Walter
K140213 03/25/2015 DISPOSABLE ENDOSCOPIC CANNULA DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD LONG YANG
K143318 03/10/2015 DR Systems Zero Download 3D Viewer (Z3D) DR Systems, Inc Kimberly J Meade
K142877 03/13/2015 EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV DANIELLE SLEEGERS
K142426 03/27/2015 EBI External Implant System EBI Inc Mi Sook Kim
K143695 03/30/2015 CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC QUEENA CHEN
K141278 03/24/2015 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K143365 03/30/2015 Eminent Foot Plate System Eminent Spine Dave Freehill
K143645 03/04/2015 EsophyX« Z Fastener Delivery Device ENDOGASTRIC SOLUTIONS, INC. DARREN CROW
DEN130047 03/20/2015 PROLONG ERGON MEDICAL LTD. BARRY PEARCE
K142822 03/26/2015 PLIASURE Polyglycolide Synthetic Absorbable Suture ETHICON, Inc. Susan Lin
K142732 03/04/2015 T3 Software Etiometry, Inc. Dimitar Baronov
K150491 03/26/2015 ER36 Series OAE Test System ETYMOTIC RESEARCH, INC. Steve Iseberg
K150309 03/04/2015 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL, LLC Brian Smekal
K141460 03/20/2015 FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR FINAPRES MEDICAL SYSTEMS BV IR. PAUL KOSTERS
K143646 03/05/2015 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit Fisher & Paykel Healthcare Ltd Elizabeth Goldstein
K142776 03/23/2015 Flow-Screw Flow-FX, LLC PATRICK J. SWEENEY
K143651 03/18/2015 Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack FOCUS DIAGNOSTICS, INC. Sharon Young
K142778 03/20/2015 ARROW Reverse Shoulder long keel and short keel glenoid base Fournitures Hospitalieres Industrie Patricia Donnard
K150030 03/16/2015 Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor Fukuda Denshi USA, Inc. Doug Blakely
K143108 03/27/2015 HealthGuard-15 FUTREX, INC. Carole Rosenthal
K143564 03/05/2015 Visual-ICE Cryoablation System, Software Revision 1.3.1 GALIL MEDICAL INC. AMY MCKINNEY
K142801 03/12/2015 Triton Canister System Gauss Surgical, Inc. Peggy McLaughlin
K143361 03/26/2015 Mammo Workstation GE HEALTHCARE Mounir Zaouali
K143389 03/06/2015 3.0T GEM RT Open Array GE HEALTHCARE COILS (USA INSTRUMENTS INC.) Candice C Mandera
K150193 03/24/2015 Customer Remote Console (CRC) GE MEDICAL SYSTEMS, LLC John W. Jaeckle
K150085 03/02/2015 GE EchoPAC GE VINGMED ULTRASOUND AS Bryan Behn
K150087 03/04/2015 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System GE VINGMED ULTRASOUND AS BRYAN BEHN
K141961 03/26/2015 GENADYNE SPIRO FOAM DRESSING KIT GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING GOH
K142218 03/31/2015 Coalition AGX Plate and Coalition AGX Spacer GLOBUS MEDICAL INC. Kelly Baker
K143287 03/24/2015 Fluidshield* Surgical Mask with Expanded Chamber Halyard Health, Inc. Roberto F. Refeca
K143095 03/24/2015 MiniStim MS-IVB Peripheral Nerve Stimulator Halyard Health, Inc. Lindsey Hedlund
K143419 03/06/2015 Patient Examination Gloves HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K150096 03/04/2015 Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K142709 03/27/2015 samaritan PAD 450P HEARTSINE TECHNOLOGIES, INC. Paul Phillips
K143414 03/10/2015 Hill-Rom Wireless Connectivity Module HILL-ROM ANN WATERHOUSE
K143537 03/06/2015 Sirius Starmobile tiara HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K142734 03/02/2015 TRILLIUM Oval MR System HITACHI MEDICAL SYSTEMS AMERICA, INC. Doug Thistlethwaite
K141944 03/13/2015 HOME ACCESS AIC TEST HOME ACCESS HEALTH CORP. Sandra D White
K150175 03/31/2015 HeatLux Pro I HOME SKINOVATIONS LTD. Ahava Stein
K143087 03/04/2015 Hospira Blood Set HOSPIRA, INC. Charles Neitzel
K140954 03/23/2015 LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. Diana Hong
K142769 03/20/2015 Fetal Doppler iCare Newlife Technologies, Inc. BO XIAO
K142781 03/31/2015 ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K150275 03/09/2015 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls Immunalysis Corporation Joseph Ginete
K143324 03/30/2015 IDS-iSYS CTX-I Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD. ROMA YOUNG
K150180 03/16/2015 InTone INCONTROL MEDICAL, LLC. JESSICA ANDRESHAK
K140806 03/23/2015 IBS IMPLANT SYSTEM INNOBIOSURG CO., LTD CHARLIE MACK
K141655 03/05/2015 QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS INOVA DIAGNOSTICS, INC. GRABRIELLA LAKOS
K143301 03/03/2015 NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit Integrated Healing Technologies Ian Baird
K142766 03/12/2015 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear INTEROJO INC. Si-Chul Rho
K143663 03/17/2015 MiroCam Capsule Endoscope System INTROMEDIC CO., LTD Jinyoung Lee
K142344 03/20/2015 DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System IZI MEDICAL PRODUCTS LLC QIANG CAO
K141825 03/03/2015 IDEAL Locking Plate System JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT ALICE GONG
K150325 03/31/2015 Range/Denali/Mesa Spinal System K2M, Inc Nancy Giezen
K143104 03/25/2015 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X KETTENBACH GMBH & CO KG Katja Simon
K142782 03/09/2015 KIMGUARD ONE-STEP Sterilization Wrap Kimberly-Clark Health Care Thomas Kozma
K143279 03/20/2015 LnK Anterior Cervical Plate System L&K BIOMED Co., Ltd. Ki-Hyang Kim
K141181 03/31/2015 NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES LED TECHNOLOGIES, LLC SUSAN ANTHONEY-DEWET
K143010 03/20/2015 LENSAR Laser System - fs 3D LENSAR, INC. MOHINDER MERCHEA
K150368 03/24/2015 Tarsa-Link Wedge Fixation System Life Spine Randy Lewis
K150390 03/16/2015 Nautilus Spinal System LIFE SPINE, INC. RANDY LEWIS
K142561 03/20/2015 LM-9300 ELMA Lithotripter LITE-MED INC. WALT HSU
K142420 03/27/2015 Patient Positioning Devices MACROMEDICS BV C de Keijzer
K150307 03/10/2015 RESTORIS Multicompartmental Knee System MAKO SURGICAL CORP. Jonathan Reeves
K150410 03/20/2015 RESTORIS POROUS PARTIAL KNEE SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K143567 03/31/2015 NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for l MARVAO MEDICAL DEVICES, LTD. CHRISTOPHER DAVEY
K143453 03/02/2015 Mpact Double Mobility System Medacta International Adam Gross
K143662 03/12/2015 Bissinger Monopolar Forceps and Cables MEDAGENT, INC Franz Menean
K143485 03/04/2015 iGuide 2.1 MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K142798 03/25/2015 PASS LP Spinal System MEDICREA INTERNATIONAL S.A. Audrey VION
K142068 03/10/2015 BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE MEDOVATIONS, INC. LAURA BOLL
K141833 03/25/2015 STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION MEDTRONIC NAVIGATION, INC. CHRISTOPHER PERMAN
K150291 03/27/2015 TYRX Neuro Absorbable Antibacterial Envelope MEDTRONIC TYRX, INC. Regina Novak
K143083 03/25/2015 Bio-Medicus Pediatric Cannula and Introducers MEDTRONIC, INC BRUCE BACKLUND
K143073 03/25/2015 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface Medtronic, Inc. Jessica Sixberry
K143316 03/11/2015 Attain Hybrid Guide Wire Medtronic, Inc. Mia Hunt
K150422 03/20/2015 EOPA 3D Arterial Cannula MEDTRONIC, INC. Chelsea L Pioske
K143032 03/29/2015 eMotion Faros ECG Mobile MEGA ELECTRONICS LTD. Taneli Vaaraniemi
K141042 03/19/2015 MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES MERCATOR MEDICAL (THAILAND) LTD. Kevin Walls
K141493 03/20/2015 PROXIMAL HUMERUS PLATING SYSTEM Miami Device Solutions PETER J MINCIELI
K142449 03/26/2015 Headway 27 Microcatheter MICRO VENTION, INC. Cynthia Valenzuela
K141455 03/16/2015 EASYDRILL AUTOSTOP CRANIAL PERFORATOR MICROMAR IND. COM. LTD. DEEP PAL
K150366 03/27/2015 SOFIA 6F Catheter MICROVENTION, INC. NAOMI GONG
K141847 03/26/2015 AVANCE FOAM DRESSING KITS MOLNLYCKE HEALTH CARE US, LLC ANGELA L BUNN, RAC
K140477 03/23/2015 BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES MOLNLYCKE HEALTH CARE US, LLC CURTIS D TRUESDALE
K150234 03/31/2015 Myriad Prostate Caddy? Immobilization Rectal Balloon Item #9901,3301 Myriad Medical, LLC Frank Bimbo
K143036 03/30/2015 Ebony PTA 0.035 Peripheral Dilatation Catheter Natec Medical Ltd Xavier De Buchere
K150448 03/19/2015 NMI PICC III and NMI PICC IV NAVILYST MEDICAL, INC. WANDA CARPINELLA
K150527 03/31/2015 Xcela Power Injectable PICC NAVILYST MEDICAL, INC. Wanda Carpinella
K141715 03/25/2015 GLOVE PORT NELIS PETER CHUNG
K150225 03/16/2015 NovaGold High Performance Guidewire NEOMETRICS, INC. Dave Liebl
K143703 03/18/2015 NICAL SMART MICRO CR system for intraoral dental images NICAL SPA ROBERTO NICCOLUCCI
K130238 03/04/2015 NIHON KOHDEN AE-918P NEURO UNIT NIHON KOHDEN CORP. NATALIE KENNEL
K150052 03/26/2015 TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System Nipro Diagnostics, Inc Simeon Simone
K142439 03/10/2015 Martinez Prostate Template Set Nucletron BV Rudolf Vos
K141665 03/13/2015 NuVasive CoRoent System NUVASIVE, INC. JEREMY MARKOVICH
K143388 03/05/2015 Affix IIS Spinous Process Plate System NuVasive, Incorporated Olga Lewis
K143641 03/27/2015 NuVasive NVM5 System NuVasive, Incorporated Jeremy Markovich
K143313 03/20/2015 NxStage Therapeutic Plasma Exchange (TPE) Cartridge NxStage Medical, Inc. Randall J Covill
K141595 03/16/2015 O-TWO E700,O-TWO E600,O-TWO E500 O-TWO MEDICAL TECHNOLOGIES, INC. David Zhang
K141991 03/31/2015 SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP OLYMPUS MEDICAL SYSTEMS COPR. DAPHNEY GERMAIN-KOLAWOLE
K143609 03/27/2015 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter OLYMPUS SURGICAL TECHNOLOGIES AMERICA MARY ANNE PATELLA
K142953 03/04/2015 OCT-Camera OptoMedical Technologies GmbH Alexander Holzhey
K143463 03/19/2015 IS4/DF4 Port Plug Oscor Inc. Dorit Segal
K150485 03/26/2015 AVERT Contrast Modulation System Osprey Medical, Inc. Melanie Hess
K141790 03/06/2015 AQANIFE OVESCO ENDOSCOPY AG TANJA R LINZER
K141717 03/09/2015 PACSEAL PIT & FISSURE SEALANT PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K150322 03/06/2015 InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) PAN MEDICAL LTD Jennie Budding
K143218 03/18/2015 Penumbra Smart Coil Penumbra, Inc. Charles DeNault
K143180 03/27/2015 F3 PERMOBIL AB JAN ASTROM
K143014 03/25/2015 F5 PERMOBIL AB Jan Astrom
K143128 03/20/2015 mDIXON XD PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. JAN VAN DE KERKHOF
K142438 03/05/2015 Nerve Monitoring Cable System Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) Sarah McIntyre
K143533 03/25/2015 FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE PROSIDYAN, INC. CHARANPREET S BAGGA
K141793 03/06/2015 PULMONE MINIBOXPFT 2.0 PULMONE ADVANCED MEDICAL DEVICES, LTD. SUSAN ALPERT
K141164 03/16/2015 ARTEMIS LIGHT ENGINE QUEST MEDICAL IMAGING MARTIN HEUVELMANS
K143329 03/17/2015 AmpliVue Trichomonas Assay QUIDEL CORPORATION RONALD H LOLLAR
K150150 03/27/2015 1717SGN / 1717SCN Digital Flat Panel X-ray Detector Rayence Co., Ltd Kevin Kim
K143753 03/10/2015 Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio Rayence Co., Ltd Kevin Kim
K142960 03/05/2015 Propeller System 2014-R Reciprocal Labs David Hubanks
K142988 03/16/2015 Sleepware G3 RESPIRONICS, INC. DANIELA AIZPITARTE
K141867 03/03/2015 ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics KHONE SAYSANA
K141929 03/16/2015 ACCU-CHEK CONNECT DIABETES MANAGEMENT APP ROCHE DIAGNOSTICS CORPORATION CHUNHONG(EMMA) TAO
K142352 03/12/2015 CardiacLinx Ross Medical Technology, Inc ALEXANDER CHIU
K150478 03/26/2015 A35 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KIM JIYOUNG
K143673 03/04/2015 CMOS Video Nasopharyngoscope System Schoelly Fiberoptic Gmbh Dr. Sandra Baumann
K150158 03/09/2015 Schoelly Cystoscopes/Hysteroscopes and Accessories Schoelly Fiberoptic GmbH Sandra Baumann
K150469 03/23/2015 Integra Laminoplasty System SEASPINE, INC. MICHELLE WILLIS
K143094 03/05/2015 QuantaFlo SEMLER SCIENTIFIC, INC. BOB MCRAE
K142992 03/18/2015 TULIP Natural Rubber Latex Surgeon's Glove (Powdered) SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD Xiaoyan Wang
K143160 03/05/2015 FOXTROT NC PTCA Balloon Catheter SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD JINGWEN LI
K142892 03/25/2015 Powder-free Clear Vinyl Patient Examination Gloves Shenyi(Shandong) Plastic Products, Co.Ltd Tyler Li
K142341 03/06/2015 X-RAY TV SYSTEM SONIALVISION G4 SHIMADZU CORP. TOSHIO KADOWAKI
K142723 03/31/2015 ADVIA Centaur Cortisol (COR) Assy Siemens Healthcare Diagnostics Inc. Fatima Pacheco
K150192 03/29/2015 Scenium SIEMENS MEDICAL SOLUTIONS USA, INC ALAINE MEDIO
K143409 03/26/2015 SOMATOM Definition AS Open (VA48) Siemens Medical Solutions USA, Inc. Eve Davis
K133838 03/11/2015 STERILIZATION POUCH/ROLL MADE WITH TYVEK SIGMA MEDICAL SUPPLIES CORP. UTA SHIH
K143184 03/17/2015 Evolve UniPolar Head Signature Orthopaedics Pty Ltd. Declan Brazil
K143096 03/24/2015 SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA Smith & Nephew, Inc. Jeff Sprague
K143386 03/13/2015 Progrip Laparoscopic Self-Fixating Mesh SOFRADIM PRODUCTION Eric Jague
DEN130046 03/06/2015 REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE SOMNA THERAPEUTICS, LLC James S. Miller
K143601 03/18/2015 U-Lite Sonoscanner SARL Bruno Richard
K150360 03/04/2015 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath SPECTRANETICS, INC. Christopher S McLellan
K150285 03/05/2015 Leva(TM) Spacer System SPINE WAVE, INC. ROAIDA JOHNSON
K143173 03/23/2015 Stryker CMF MEDPOR Customized Implant Stryker Julie Schoell
K150449 03/20/2015 LITe Plate System STRYKER CORP. GARRY T. HAYECK
K143616 03/05/2015 AccuLIF TL and PL Cage STRYKER CORPORATION Aakash Jain
K143546 03/19/2015 Imbibe Aspirating XIA Taps Stryker Corporation Soraya King
K140356 03/20/2015 SUMMED HIGH PRESSURE LINE SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD JAMES QI ZHANG
K143404 03/20/2015 SurgiQuest AirSeal iFS System SURGIQUEST, INC. Daniel Donovan
K142001 03/18/2015 SYNTEC WETALI ORTHODONTIC MINI SCREWS SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE KAVIN CHU
K150099 03/23/2015 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) SYNTHES (USA) PRODUCTS, LLC NICHOLAS FOUNTOULAKIS
K141527 03/30/2015 DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM SYNTHES USA ANGELA F LASSANDRO
K141524 03/12/2015 NEURO-AUDIO TELEEMG, LLC USA BARRY ASHAR
K140110 03/27/2015 FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET TELEFLEX, INC. CHET JONES
K141938 03/23/2015 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) TERUMO BCT, INC.. PATTI ARNDT
K142649 03/24/2015 Progressive Orthopedic Total Knee System The Progressive Orthopaedic Company, LLC Scott Keiser
K143526 03/05/2015 The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientfic Cynthia Knapp
K142338 03/02/2015 Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K143552 03/04/2015 Simpliciti Shoulder System TORNIER, INC. Loucinda Bjorklund
K150003 03/19/2015 Aquilion LB, TSX-201A/3, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K142465 03/10/2015 Aquilion ONE Vision, v7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K142736 03/11/2015 XIDF-AWS801, Angio Workstation, v5.31 Toshiba Medical Systems Corporation Paul Biggins
K143717 03/19/2015 Treace Medical Concepts(TMC) Plating System Treace Medical Concepts, INc. Joe Ferguson
K141624 03/10/2015 PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K142236 03/23/2015 BioniCare Hand System VISION QUEST INDUSTRIES, INC. MOHAMED OUERGHI
K143211 03/20/2015 myVision Track Model 005 VITAL ART AND SCIENCE INCORPORATED Michael Bartlett
K150258 03/05/2015 Vitrea, Version 7.0 Medical Image Processing Software Vital Images, Inc Parthiv Shah
K150441 03/20/2015 Volcano iFR Modality, iFR Scout feature VOLCANO CORPORATION NEETA SHARMA
K142923 03/05/2015 TraumaCad Mobile Release 1.0 Voyant Health Ltd Yael Guttentag
K150551 03/30/2015 GORE SEAMGUARD Reinforcement W. L. GORE & ASSOCIATES, INC. BARBARA L. SMITH
K141767 03/09/2015 ID MILLENNIUM, ID MOMENTS SILICONE WESTRIDGE LABORATORIES, INC. ALBERT REGO
K141085 03/27/2015 WestTec Procedure Facemask;WestTec Surgical Facemask WESTTEC, LLC JOHN JENSEN
K141740 03/05/2015 INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K142117 03/25/2015 INVISION TOTAL ANKLE REVISION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K150004 03/04/2015 SALVATION External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K143158 03/20/2015 Xenco Medical Lumbar Interbody System Xenco Medical, LLC Gustavo Prado
K143216 03/17/2015 Assurance Alar / Nasal SpO2 Sensor Xhale, Inc. Jeffrey Hoebelheinrich
K141467 03/05/2015 SURGICAL GOWN XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L MIKE GU
K142206 03/13/2015 Dental Unit Zhuhai Siger Medical Equipment Co., Ltd Huisheng Wang
K143626 03/20/2015 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele Zimmer Spine, Inc. Donna M. Semlak
K143165 03/31/2015 Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw Zimmer, Inc. Patrick McCullagh
K143331 03/04/2015 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS ZIMMER, INC. Patrick McCullagh
K150249 03/04/2015 ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System ZONARE MEDICAL SYSTEMS, INC. Steve Geerdes


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