FDA 510(k) Decisions During March, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K143207 03/23/2015 Revitive IX (OTC) Actegy, Ltd Angela Glover
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
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
K143519 03/10/2015 The MeDioStar NeXT Family ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K143492 03/04/2015 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA Judith Clerc
K143379 03/13/2015 Liquichek Maternal Serum II Control Bio-Rad Laboratories Elizabeth Platt
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
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
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
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
K143725 03/04/2015 Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc Matthew M Hills
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
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
K150196 03/26/2015 DD cubeX2 DENTAL DIREKT GMBH UWE GREITENS
K150375 03/11/2015 LIAISON VZV IgG, LIAISON Control VZV IgG DiaSorin Inc. John Walter
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
K143695 03/30/2015 CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC QUEENA CHEN
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
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
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
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
K150175 03/31/2015 HeatLux Pro I HOME SKINOVATIONS LTD. Ahava Stein
K143087 03/04/2015 Hospira Blood Set HOSPIRA, INC. Charles Neitzel
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
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
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
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
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
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
K150366 03/27/2015 SOFIA 6F Catheter MICROVENTION, INC. NAOMI GONG
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
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
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
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
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
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
K143533 03/25/2015 FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE PROSIDYAN, INC. CHARANPREET S BAGGA
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
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
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
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
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
K143404 03/20/2015 SurgiQuest AirSeal iFS System SURGIQUEST, INC. Daniel Donovan
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
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
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
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
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
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
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


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