| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K143026 |
11/21/2014 |
Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity |
AALTO SCIENTIFIC LTD. |
ROBERT BURDA |
| K142978 |
11/20/2014 |
Audit MicroControls Linearity LQ Special Diabetes |
AALTO SCIENTIFIC LTD. |
Robert Burda |
| K142467 |
11/24/2014 |
IntelAir Nasal Airway Support System |
ABEON MEDICAL CORPORATION |
ALLISON SLAGA |
| K141194 |
11/19/2014 |
FM-3000 FETAL MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K141038 |
11/12/2014 |
ANT MODEL 1 |
ADVANCED NUCLIDE TECHNOLOGIES, LLC |
SERGEY BAKLANOV, PH.D. |
| K133898 |
11/06/2014 |
NIOX VERO AIRWAY INFLAMMATION MONITOR |
AEROCRINE AB |
Susanne Parks |
| K143106 |
11/21/2014 |
VEGA Knee System |
AESCULAP IMPLANT SYSTEMS, LLC |
Julie Tom Wing |
| K142315 |
11/14/2014 |
MINOP Disposable Introducer 26F |
AESCULAP, INC. |
KATHY RACOSKY |
| K141993 |
11/06/2014 |
NAKOMA ACP |
ALLIANCE PARTNERS, LLC |
KELLEN HILLS |
| K142347 |
11/18/2014 |
Amedica Valeo II Interbody Fusion Device |
Amedica Corp |
William D Jordan |
| K142593 |
11/12/2014 |
AngioVac Cannula |
AngioDynamics, Inc. |
Wanda Carpinella |
| K143001 |
11/07/2014 |
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING |
ARGENTUM MEDICAL |
C. Richard Foster |
| K143047 |
11/19/2014 |
Arthrex iBalance Patella Implant, Dome |
ARTHREX, INC. |
LAURA MEDLIN |
| K142863 |
11/25/2014 |
Univers Rivers Shoulder Prosthesis System |
Arthrex, Inc. |
Courtney Smith |
| K142999 |
11/19/2014 |
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable |
ArthroCare Corporation |
Ashley M. Johnston |
| K142413 |
11/14/2014 |
TITAN Modular Total Shoulder System |
Ascension Orthopedics |
Frederic Testa |
| K142203 |
11/25/2014 |
Atricure Cryo Module System; cryoICE cryoablation probe |
ATRICURE, INC. |
Jonathan McElwee |
| K141317 |
11/17/2014 |
ZIP MIS INTERSPINOUS FUSION SYSTEM |
AURORA SPINE, INC. |
JUSTIN EGGLETON |
| K142147 |
11/24/2014 |
EEVA SYSTEM |
AUXOGYN, INC. |
JULIA S ANASTAS |
| K140595 |
11/17/2014 |
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
LOUIS FRIES |
| K141342 |
11/14/2014 |
WEARABLE THERAPY GARMENTS |
AXIOBIONICS LLC |
ROBERT J BARD |
| K143157 |
11/12/2014 |
Coronis Fusion 4MP LED |
BARCO NV |
LIEVEN DE WANDEL |
| K142600 |
11/19/2014 |
VIAL-MATE Adaptor |
BAXTER HEALTHCARE CORPORATION |
GARY CHUMBIMUNE |
| K142023 |
11/20/2014 |
LUNA INTERBODY SYSTEM |
BENVENUE MEDICAL, INC. |
CINDY DOMECUS, R.A.C. (US & EU) |
| K142219 |
11/13/2014 |
GammaBeam 100 |
Best Theratronics Limited |
Mike de van der Schueren |
| K142640 |
11/06/2014 |
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator |
BIO COMPRESSION SYSTEMS, INC. |
Barbara Whitman |
| K142099 |
11/17/2014 |
CUTANEOUS ELECTRODES |
BIO PROTECH, INC. |
Terry Kim |
| K133303 |
11/19/2014 |
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device |
BIO-ANALYSIS, INC. |
REGINA J O'MEARA |
| K142292 |
11/17/2014 |
Speed, Speed Shift, Speed Titan, Speed Arc |
BioMedical Enterprises, Inc. |
Joe Soward |
| K142658 |
11/13/2014 |
Biomet Headless Compression and Twist-off Screws |
BIOMET MANUFACTURING CORP. |
Victoria Scheitlin |
| K141263 |
11/19/2014 |
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS |
BIOMET MANUFACTURING CORP. |
JARED COOPER |
| K133518 |
11/05/2014 |
MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
KIMBERLY MCCOY |
| K142020 |
11/05/2014 |
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 |
BIOMONDE |
ROSINA ROBINSON, RN, MED, RAC |
| K142513 |
11/13/2014 |
Barricade Embolization Coil System |
BLOCKADE MEDICAL |
Rebecca K Pine |
| DEN140025 |
11/17/2014 |
BrainScope Ahead 100 |
BRAINSCOPE COMPANY, INC |
Michael E. Singer |
| K140732 |
11/07/2014 |
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS |
CANDELA CORP. |
SAM WADE |
| K140497 |
11/19/2014 |
ECVUE MAPPING SYSTEM |
CARDIOINSIGHT TECHNOLOGIES, INC |
CHRISTINA V VACCA |
| K143234 |
11/20/2014 |
MaxZero Administration Sets |
CAREFUSION |
LARRY WALKER |
| K141844 |
11/18/2014 |
RESCAN 700, CALLISTO EYE |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
| K142399 |
11/19/2014 |
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) |
CATHETER CONNECTIONS, INC. |
Donald d Soloman |
| K142047 |
11/12/2014 |
EIDON |
CENTERVUE SPA |
ROGER GRAY |
| K141942 |
11/07/2014 |
MIDLINE II TI |
CENTINEL SPINE, INC. |
JUSTIN EGGLETON |
| K142045 |
11/22/2014 |
XPERT FLU/RSV XC ASSAY |
CEPHEID |
SCOTT A CAMPBELL,PH.D.,MBA |
| K142501 |
11/26/2014 |
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
CEPHEID |
KERRY J. FLOM |
| K141606 |
11/17/2014 |
SURGICAL GOWN |
COBES INDUSTRIES CO., LTD. |
LYNN FU |
| K142496 |
11/24/2014 |
Collagen Dental Membrane - Conformable IIBP |
COLLAGEN MATRIX, INC. |
GLORIA ZUCLICH |
| K141909 |
11/05/2014 |
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K141718 |
11/13/2014 |
INTERNAL HYDRATING GEL |
COMBE INCORPORATED |
PUSHPA RAO |
| K130019 |
11/18/2014 |
J-SCREW COMPRESSION SCREW |
COMPETITIVE ENGINEERING INC. |
DAVID M DAVIS |
| K142161 |
11/14/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K140085 |
11/18/2014 |
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER |
COOK INCORPORATED |
ELYSIA EASTON |
| K142301 |
11/12/2014 |
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath |
COOK VASCULAR, INC. |
Thomas J. Kardos |
| K141523 |
11/25/2014 |
ALLY UPS |
COOPER SURGICAL, INC. |
TIM M LOHNES |
| K140438 |
11/14/2014 |
MICRO GUIDE CATHETER ELITE |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
Michelle Ragozzine Rodgers |
| K140573 |
11/24/2014 |
WOUNDCLOT HEMOSTATIC GAUZE |
CORE SCIENTIFIC LTD. |
Sigalit Ariely-Portnoy |
| K142012 |
11/20/2014 |
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWKI |
| K142695 |
11/26/2014 |
Cytosponge Cell Collection Device |
Covidien LLC |
Richelle Hover |
| K143091 |
11/26/2014 |
Surgisleeve Wound Protector |
Covidien LLC |
Michael Koczocik |
| K140566 |
11/24/2014 |
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE |
CROSSTEX INTERNATIONAL |
MICHAEL G NOLAN |
| K142072 |
11/24/2014 |
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) |
CUSTOM ORTHOPAEDIC SOLUTIONS, INC. |
JUSTIN J BAKER,PHD |
| K140727 |
11/06/2014 |
CUTERA PICOSECOND LASER SYSTEM |
CUTERA, INC. |
BRADLEY RENTON |
| K142428 |
11/13/2014 |
Shock Pulse-SE Lithotripsy System CYBERWAND II |
CYBERSONICS, INC. |
Jeff Vaitekunas |
| K141503 |
11/10/2014 |
DENALI 501CEMENT |
DENALI CORPORATION |
JAN G STANNARD |
| K141457 |
11/12/2014 |
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS |
DENTIUM CO. LTD. |
SHERYL HIGGINS |
| K142185 |
11/19/2014 |
EXPEDIUM VERSE SPINE SYSTEM |
DEPUY SPINE, INC. |
CATHERINE KILSHAW |
| K142587 |
11/18/2014 |
Vertical Expandable Prosthetic Titanium Rib |
Depuy Synthes Spine, Inc. |
Catherine Kilshaw |
| K133434 |
11/26/2014 |
GENESIS II |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K133175 |
11/13/2014 |
DRAEGER JAUNDICE METER JM-105 |
DRAEGER MEDICAL SYSTEMS, INC. |
BRYAN OVERTON |
| DEN100024 |
11/07/2014 |
ZAP-IT! |
ECOBRANDS LTD. |
Kevin Walls |
| K141958 |
11/18/2014 |
ERB ENDORECTAL BALLOON |
EDGE MEDICAL LLC |
GREGORY MATHISON |
| K143261 |
11/21/2014 |
2.3MP Color LCD Monitor, RadiForce MX242W |
EIZO CORPORATION |
Hiroaki Hashimoto |
| K143098 |
11/18/2014 |
3MP Color LCD monitor, RadiForce RS340 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K141990 |
11/07/2014 |
ENCORE HUMERAL SHOULDER STEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K140130 |
11/06/2014 |
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K140389 |
11/07/2014 |
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 |
ENTROTECH LIFE SCIENCES INC. |
VALERIE DEFIESTA-NG |
| K141952 |
11/24/2014 |
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED |
ETHICON ENDO-SURGERY, INC. |
LINDA HILL |
| K133446 |
11/14/2014 |
HEPARIN LOCK / FLUSH SYRINGES |
Excelsior Medical Corporation |
JOHN LINFANTE |
| K142810 |
11/14/2014 |
WEGO-PGCL Absorbable Surgical Monofilament Suture |
FOOSIN MEDICAL SUPPLIES INC.LTD |
Suxia Zhao |
| K142098 |
11/24/2014 |
SIGNA PET/MR |
GE MEDICAL SYSTEMS, LLC |
ROBIN MARTIN |
| K143156 |
11/18/2014 |
Sentinella 102; Sentinella 102 Horus |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
Jose Montes |
| K142938 |
11/26/2014 |
G3 Active Plate Large Fragment System |
GENESIS FRACTURE CARE, INC. |
Michael Bottlang |
| K140041 |
11/28/2014 |
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM |
GENORAY CO., LTD. |
KAITLYNN MIN |
| K133766 |
11/24/2014 |
HUMICARE D900 |
GRUENDLER GMBH |
JIM CASSI |
| K142270 |
11/25/2014 |
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| DEN130045 |
11/26/2014 |
HEARTFLOW FFRCT |
HEARTFLOW |
Dustin Michaels |
| K140934 |
11/12/2014 |
HIOSSEN IMPLANT SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K142029 |
11/26/2014 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K141792 |
11/25/2014 |
GENESIS TOUCH SYSTEM |
HONEYWELL HOMMED |
CLAUDIA JACKSON |
| K142367 |
11/25/2014 |
Hospira Primary Sets |
HOSPIRA, INC. |
CATHERINE KANG |
| K141872 |
11/21/2014 |
SUDOSCAN |
IMPETO MEDICAL INC |
Calley Herzog |
| K141341 |
11/14/2014 |
CL DETECT RAPID TEST |
INBIOS INTERNATIONAL INC. |
ESTELA RAYCHAUDHURI |
| K141158 |
11/26/2014 |
APEX |
INCONTROL MEDICAL, LLC |
JESSICA ANDRESHAK |
| K141682 |
11/24/2014 |
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K141644 |
11/07/2014 |
INNOVASIS CRANIAL SYSTEM |
INNOVASIS, INC. |
MARSHALL MCCARTY |
| K141967 |
11/07/2014 |
PUREFILL OXYGEN COMPRESSOR |
INOVO, INC. |
PAUL DRYDEN |
| K140078 |
11/14/2014 |
TECOTHERM NEO (T NEO) |
INSPIRATION HEALTHCARE LTD |
WAYNE IDDON |
| K140439 |
11/13/2014 |
OMNIPOD INSULIN MANAGEMENT SYSTEM |
INSULET CORPORATION |
ANTONETTE M DELEO, RAC |
| K141668 |
11/06/2014 |
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
JANET C KAY |
| K141674 |
11/06/2014 |
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
TIMOTHY CONNORS |
| K142238 |
11/24/2014 |
MAYFIELD Skull Clamp |
INTEGRA LIFESCIENCES CORPORATION |
Brian Hoy |
| K140716 |
11/24/2014 |
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE |
INTERVENTIONAL SPINE, INC. |
JANE METCALF |
| K142668 |
11/21/2014 |
Lesion-Loc Iodine I-125 Seed/Needle |
Intramedical Imaging, LLC |
Farhad Daghighian |
| K141338 |
11/04/2014 |
LIAT STREP A ASSAY |
IQUUM INC |
Lingjun Chen |
| K142681 |
11/21/2014 |
ZEUS (ZIO ECG Utilization Service) System |
iRhythm Technologies, Inc. |
Rich Laguna |
| K142389 |
11/25/2014 |
Variolink Esthetic |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K143076 |
11/12/2014 |
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K142016 |
11/06/2014 |
CAPRI |
K2M, INC. |
NANCY GIEZEN |
| K140963 |
11/10/2014 |
KIMGUARD SMART-FOLD STERILIZATION WRAP |
KIMBERLY-CLARK CORP. |
THOMAS KOZMA, PH.D. |
| K142197 |
11/21/2014 |
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 |
KONICA MINOLTA INC. |
SHIGEYUKI KOJIMA |
| K140352 |
11/13/2014 |
VERAPLUG |
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS |
ARCHNA JOHNSON |
| K142393 |
11/25/2014 |
PREDICATE III GUIDEWIRE |
LAKE REGION MEDICAL |
MATHEW PEXA |
| K141877 |
11/10/2014 |
LEAF PATIENT MONITORING SYSTEM |
LEAF HEALTHCARE, INC. |
RONALD S WARREN |
| K140768 |
11/25/2014 |
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT |
LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. |
ARTHUR GODDARD |
| K133997 |
11/21/2014 |
LG SMARTHEALTH |
LG ELECTRONICS |
DIANE SUDDUTH |
| K142139 |
11/07/2014 |
SMR 40MM GLENOSPHERE |
LIMACORPORATE S.P.A. |
STEPHEN PEOPLES |
| K142215 |
11/07/2014 |
Power Twin21-50/Power Twin21-100 |
LIVETEC GMBH |
Klaus Reichebach |
| K141555 |
11/06/2014 |
ADVANTAGE |
LUTRONIC CORPORATION |
JHUNG W VOJIR |
| K141989 |
11/13/2014 |
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
JONATHAN REEVES |
| K140569 |
11/19/2014 |
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) |
MAQUET CARDIOPULMONARY AG |
SARAH BETZ |
| K140492 |
11/13/2014 |
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE |
MARVAO MEDICAL DEVICES, LTD. |
CHRISTINE NICHOLS |
| K142394 |
11/25/2014 |
Masimo Root Monitoring System and Accesories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K140222 |
11/17/2014 |
SAIPH KNEE SYSTEM |
MATORTHO |
MARCOS VELEZ-DURAN |
| K142303 |
11/20/2014 |
NeumoFilt Ergo/Neumo Filt BiteOn |
Medical Respiratory Devices S.L. |
Jose Alberto Hernandez |
| K140738 |
11/04/2014 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
David Ryan |
| K142684 |
11/06/2014 |
FlexCath Select Steerable Sheath (10 French) |
Medtronic CryoCath LP |
Vanessa Ware |
| K142673 |
11/18/2014 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic, Inc |
Bruce Backlund |
| K141377 |
11/21/2014 |
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K140382 |
11/25/2014 |
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY |
MERIT MEDICAL SYSTEMS, INC. |
DAN LINDSAY |
| K142265 |
11/13/2014 |
ONE Snare Endovascular Microsnare System |
MERIT MEDICAL SYSTEMS, INC. |
Mark Mullaney |
| K141408 |
11/26/2014 |
RESOLVE BILIARY LOCKING DRAINAGE CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
Glen Norton |
| K142550 |
11/07/2014 |
EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments |
MICROPORT ORTHOPEDICS INC. |
Caroline Fryar |
| K134006 |
11/21/2014 |
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE |
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED |
THOMAS CHAN TSZ FUNG |
| K133989 |
11/25/2014 |
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K141811 |
11/19/2014 |
MORTARA MONITORING WAVEFORM VIEWER |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K141771 |
11/07/2014 |
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY |
NANOSTRING TECHNOLOGIES INC. |
SYLVA KRIZAN |
| K142903 |
11/12/2014 |
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US |
NEOSURGICAL LTD |
Oria Brennan |
| K141462 |
11/19/2014 |
VARIA-NCI |
NEUROCHAOS SOLUTIONS, INC. |
ELISA MALDONADO-HOLMERTZ |
| K142470 |
11/05/2014 |
E-Shield Multi-paried Subdermal Needle Electrodes |
NEUROINVENT INC. |
CHAO SHENT-CHAO |
| K140586 |
11/17/2014 |
ASCEND ELECTRODE |
NEUROMETRIX, INC. |
RAINER MAAS |
| K142060 |
11/18/2014 |
TRANSOM ANTERIOR CERVICAL PLATE |
NEUROSTRUCTURES, INC. |
MEREDITH MAY |
| K133507 |
11/05/2014 |
GUIDOSS |
NIBEC CO LTD |
DANIEL NAM |
| K142424 |
11/25/2014 |
DR300 HOLTER MONITOR |
NORTH EAST MONITORING INC. |
SHERRY STEELE |
| K141994 |
11/14/2014 |
BULK FILL FLOWABLE COMPOSITE |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
| K141968 |
11/14/2014 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
JEREMY MARKOVICH |
| K142299 |
11/25/2014 |
CoRoent Small Interlock System |
NUVASIVE, INCORPORATED |
Cynthia Adams |
| K141896 |
11/20/2014 |
COROENT SYSTEM |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K142499 |
11/19/2014 |
Reline System |
NUVASIVE, INCORPORATED |
Olga Lewis |
| K142594 |
11/28/2014 |
nva, nvp, nvt |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
Brian Kieser |
| K142525 |
11/21/2014 |
PK Lap Loop |
Olympus Winter & Ibe GmbH |
Graham A.L. Baillie |
| K140807 |
11/12/2014 |
COMPOSITE ORTHODONTIC BRACKETS |
ORTHO SPECIALTIES |
PAULA WENDLAND |
| K141571 |
11/12/2014 |
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM |
ORTHOFIX SRL |
TROY BROOKS |
| K133827 |
11/17/2014 |
A-LINK Z |
OSTEO VASIVE LLC |
KEVIN A THOMAS |
| K141794 |
11/19/2014 |
ENDO-MARYLAND DISSECTOR |
OVESCO ENDOSCOPY AG |
TANJA R LINZER |
| K140923 |
11/18/2014 |
TRACTION POLYPECTOMY SNARE |
OVESCO ENDOSCOPY AG |
TANJA LINZER |
| K133980 |
11/07/2014 |
PANTHEON ELECTROSTIMULATOR |
PANTHEON RESEARCH |
YOLANDA SMITH |
| K143074 |
11/25/2014 |
Sherpa Pak Cardiac Transport System |
PARAGONIX TECHNOLOGIES, INC. |
Lisa Anderson |
| K143054 |
11/25/2014 |
Sherpa Pak Kidney Transport System |
PARAGONIX TECHNOLOGIES, INC. |
Lisa Anderson |
| K140884 |
11/26/2014 |
SYMETREX LONG TERM HEMODIALYSIS CATHETER |
PHASE ONE MEDICAL |
ADITYA SUKTHANKAR |
| K133674 |
11/21/2014 |
PHILIPS IQON SPECTRAL CT |
PHILIPS HEALTHCARE (CLEVELAND) |
CATHERINE M CONNELL |
| K140535 |
11/25/2014 |
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MICHAEL ASMALSKY |
| K141839 |
11/17/2014 |
PREMIER ETCH |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
| K142118 |
11/25/2014 |
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE |
PRISMATIK DENTALCRAFT, INC. |
BRANDON SHEPARD |
| K142115 |
11/13/2014 |
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT |
PRISMATIK DENTALCRAFT, INC. |
BRANDON SHEPARD |
| K141887 |
11/06/2014 |
OBSIDIAN PRESS (ALL CERAMIC AND POM) |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K142868 |
11/21/2014 |
5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin |
Purple Surgical International Limited |
Jason Howes |
| K142802 |
11/24/2014 |
Atlas SPEEDER Head/Neck |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K132691 |
11/13/2014 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
SOREN BOGESTRAND |
| K140193 |
11/04/2014 |
DUREX EMBRACE PERSONAL LUBRICANT |
RECKITT BENCKISER, LLC |
SAPANA AMIN |
| K141649 |
11/05/2014 |
SPEX SUPPORT CATHETER |
REFLOW MEDICAL |
Rebecca K Pine |
| K141676 |
11/04/2014 |
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM |
Renovis Surgical Technologies, Inc. |
Sharyn Orton, Ph.D. |
| K140424 |
11/14/2014 |
RESPIRONICS REUSABLE HEATED TUBING |
RESPIRONICS, INC. |
ALEXANDER L FRIEDMAN |
| K141617 |
11/14/2014 |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL, L.P. |
SUSAN D GOLDSTEIN-FALK |
| K141928 |
11/25/2014 |
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR |
Roche Diagnostics Operations (RDO) |
NOEL K MENCIAS |
| K140910 |
11/19/2014 |
CENTERCROSS CATHETER |
ROXWOOD MEDICAL, INC. |
MEHRDAD FARHANGNIA |
| K142243 |
11/18/2014 |
LessRay with Tracking |
SAFERAY SPINE, LLC |
Michael Alrutz |
| K143089 |
11/26/2014 |
WS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| K141755 |
11/19/2014 |
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K133362 |
11/21/2014 |
SGS DENTAL IMPLANT |
SGS INTERNATIONAL LTD |
DANIELA LEVY |
| K141640 |
11/19/2014 |
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE |
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
CHARMAINE HENDERSON |
| K141076 |
11/14/2014 |
GARMENT ELECTRODES |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
QILIAN LIU |
| K142601 |
11/14/2014 |
Panorama Patient Monitoring Network |
Shenzhen Mindray Bio-Medical Electronics Co. |
Diane Arpino |
| K133929 |
11/12/2014 |
HEALTH EXPERT ELCTRONIC STIMULATOR |
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED |
LI YANG |
| K140717 |
11/17/2014 |
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
Susan Tibedo |
| K140842 |
11/26/2014 |
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K140859 |
11/26/2014 |
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K142434 |
11/21/2014 |
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K141977 |
11/19/2014 |
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K133643 |
11/13/2014 |
SYNGO, CT LIVER ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
KIMBERLY MANGUM |
| K142520 |
11/20/2014 |
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software |
Smith & Nephew, Inc |
Martin Ostmann |
| K141471 |
11/14/2014 |
JOURNEY II XR KNEE SYSTEM |
SMITH & NEPHEW, INC. |
Shereen Bienz |
| K142908 |
11/14/2014 |
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh |
SOFRADIM PRODUCTION |
Eric Jague |
| K133348 |
11/21/2014 |
STIM PROBE |
SPES MEDICA S.R.L. |
GIORGIO FACCO |
| K141333 |
11/25/2014 |
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
MEREDITH MAY MS, RAC |
| K141537 |
11/25/2014 |
IN:C2 SPINAL FIXATION SYSTME |
SPINESMITH HOLDINGS, LLC |
CLIFTON (CHRIS) NAIVAR |
| K142272 |
11/25/2014 |
SNaP Wound Care System |
SPIRACUR, INC. |
Lawrence Hu |
| K140691 |
11/06/2014 |
IG_PLEX CELIAC DGP PANEL |
SQI DIAGNOSTICS SYSTEMS INC. |
Kate Smith |
| K142254 |
11/13/2014 |
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector |
St. Jude Medical |
Geena George |
| K140466 |
11/13/2014 |
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 |
ST. JUDE MEDICAL SYSTEMS AB |
Jeffrey Roberts |
| K141238 |
11/03/2014 |
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR |
STERILUCENT, INC |
PETER KALKBRENNER |
| K142066 |
11/13/2014 |
AERO-LL LUMBAR CAGE SYSTEM |
STRYKER CORPORATION |
Alan Traettino |
| K142251 |
11/19/2014 |
AVS AS PEEK Spacer |
Stryker Corporation |
Garry T Hayeck |
| K142565 |
11/14/2014 |
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter |
Stryker Neurovascular |
Yoko Enrile |
| K142462 |
11/14/2014 |
Restoration Anatomic Shell |
STRYKER ORTHOPAEDICS |
Denise Daugert |
| K140961 |
11/10/2014 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM |
Stryker Trauma AG |
NESLI KARAKAYA, RAC |
| K142100 |
11/20/2014 |
AIXPLORER |
SUPERSONIC IMAGINE |
AURELIE GRUENER |
| K142290 |
11/24/2014 |
KangLi pedical screw spinal system |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
Jin Hua Huang |
| K142510 |
11/19/2014 |
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens |
Synergeyes, Inc. |
Steven L. Ziemba |
| K142461 |
11/25/2014 |
VASCU-GUARD Peripheral Vascular Patch |
Synovis Life Technologies Inc. |
Jodi Jorgenson |
| DEN130019 |
11/07/2014 |
ZANZA-CLICK |
TECNIMED S.R.L. |
Claude Berthoin |
| K141939 |
11/24/2014 |
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET |
Teleflex Medical, Inc. |
JAMES A COCHIE |
| K141940 |
11/24/2014 |
CONCHASMART COLUMN |
TELEFLEX, INC. |
Amanda Webb |
| K140355 |
11/06/2014 |
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K142183 |
11/21/2014 |
GLIDESHEATH SLENDER |
Terumo Medical Corporation |
Erin Doyle |
| K141345 |
11/18/2014 |
AEQUALIS FX2 |
Tornier SAS |
MAUD ANDRIOLLO |
| K141741 |
11/26/2014 |
AQUILION PRIME, V6.00 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
ORLANDO TADEO |
| K143046 |
11/19/2014 |
Xario 100, V3.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K143027 |
11/20/2014 |
Xario 200, V3.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K131973 |
11/18/2014 |
UNEXEF-38G ULTRASOUND SYSTEM |
TOYOTA TSUSHO CORPORATION |
DOUG BLAKELY |
| K133896 |
11/13/2014 |
REJUVALITE MD |
TROPHY SKIN, INC. |
SUSAN ANTHONEY-DEWET |
| K133166 |
11/06/2014 |
INS HILDEN TIBIAL ARZZT |
TRUEMED GROUP, LLC |
RHONDA ALEXANDER |
| K142489 |
11/04/2014 |
Unimed Disposable ECG lead wires |
UNIMED MEDICAL SUPPLIES INC. |
Tan Xinmei |
| K141593 |
11/13/2014 |
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH |
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
LONG YANG |
| K142062 |
11/20/2014 |
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT |
VASCULAR FLOW TECHNOLOGIES LTD |
EDWIN LINDSAY |
| K143038 |
11/20/2014 |
Gel-Block 10X embolization pledgets |
VASCULAR SOLUTIONS, INC. |
ADAM ETTL |
| K142065 |
11/25/2014 |
TURNPIKE CATHETER |
VASCULAR SOLUTIONS, INC. |
ELLIE GILLESPIE |
| K142093 |
11/14/2014 |
V20 SYSTEM |
VIORA LTD. |
OMRI KESLER |
| K142187 |
11/06/2014 |
LINK MP RECONSTRUCTION PROSTHESIS |
WALDEMAR LINK GMBH & CO. KG |
THOMAS MEHLER |
| K141299 |
11/14/2014 |
OTC COMBO TENS/EMS SYSTEM |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
| K142950 |
11/05/2014 |
Acrobat Calibrated Tip Wire Guide |
Wilson-Cook Medical, Inc |
Doris A Hawks |
| K142585 |
11/20/2014 |
PhaLinx Hammertoe System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K141390 |
11/18/2014 |
INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
WUHAN LANDING MEDICAL HI-TECH LTD |
YAN LIU |
| K140853 |
11/06/2014 |
STIMPOD ST2-3010 NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY) LTD |
Roche van Rensburg |
| K140951 |
11/10/2014 |
YEESCOPE LARYNGOSCOPES |
YEESCOPE PTY. LTD. |
PAUL DRYDEN |
| K140246 |
11/06/2014 |
YONGFA |
YONGFA GLOVE CO., LTD. |
CHU XIAOAN |
| K140244 |
11/06/2014 |
YONGHE |
YONGHE PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K141231 |
11/25/2014 |
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY |
ZELLER POWER PRODUCTS (BATTERY BEAST, LLC) |
DOUGLAS AUSTIN |
| K142403 |
11/24/2014 |
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System |
ZIMMER GMBH |
Roberto Tommasini |
| K143066 |
11/28/2014 |
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers |
ZIMMER, INC. |
PATRICK MCULLAGH |
| K142836 |
11/12/2014 |
Zimmer Plates and Screws (ZPS), Forte Screws |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K132230 |
11/05/2014 |
ICE ZIRKON TRANSLUZENT |
ZIRKONZAHN SRL |
DONNA M HARTNETT |
| K140502 |
11/06/2014 |
ZOLL E SERIES ALS |
ZOLL MEDICAL CORPORATION |
TANMAY B SHUKLA |
| K141774 |
11/19/2014 |
ZOLL X SERIES |
ZOLL MEDICAL CORPORATION |
TAMMAY SHUKLA |
