FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K121484 |
10/19/2012 |
3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER |
3M COMPANY |
SUZANNE LEUNG |
K121741 |
10/18/2012 |
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) |
4-WEB, INC. |
RICH JANSEN, PHARM, D. |
K121876 |
10/19/2012 |
VERTECEM II CEMENT KIT |
AAP BIOMATERIALS GMBH |
VOLKER STIRNAL |
K113602 |
10/31/2012 |
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM |
AAP IMPLANTATE AG |
MARC SEEGERS |
K121721 |
10/15/2012 |
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) |
ABBOTT MEDICAL OPTICS INC |
ABBAS M BOHRA |
K122137 |
10/26/2012 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
K122446 |
10/26/2012 |
LIQUIDBAND FLOW CONTROL |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
MICHAEL BROWNE |
K120148 |
10/02/2012 |
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
K111518 |
10/03/2012 |
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K111519 |
10/03/2012 |
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K122044 |
10/04/2012 |
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K112087 |
10/15/2012 |
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
K122985 |
10/26/2012 |
COLUMBUS REVISION KNEE SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
JULIE TOM WING |
K120889 |
10/15/2012 |
AESKUSLIDES ANA HEP-2 |
AESKU DIAGNOSTICS |
HELENE PAXTON |
K121379 |
10/11/2012 |
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY |
AIRON CORPORATION |
G. ERIC GJERDE |
K122133 |
10/02/2012 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
AIRSTRIP TECHNOLOGIES, LP |
|
K121272 |
10/15/2012 |
PROTECH DENT |
AKERVALL TECHNOLOGIES INC |
SASSA AKERVALL |
K122757 |
10/05/2012 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ, PH.D. |
K120401 |
10/05/2012 |
ALAMO T |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
K121805 |
10/16/2012 |
AMS LARGE PORE POLYPROPHLENE MESH |
AMERICAN MEDICAL SYSTEMS |
RENEE MELLUM |
K121483 |
10/15/2012 |
REUSABLE CUTANEOUS ELECTRODE |
AMPCARE, LLC |
DIANE RUTHERFORD |
K121697 |
10/15/2012 |
FINGERTIP PULSE OXIMETER |
ANDON HEALTH CO., LTD |
LIU YI |
K122130 |
10/31/2012 |
WINX SLEEP THERAPY SYSTEM |
APNICURE, INC. |
CHRIS DANIEL |
K120340 |
10/19/2012 |
VENUS FACET SCREW SYSTEM |
APOLLO SPINE, INC. |
CHRISTINE SANTAGATE |
K122619 |
10/02/2012 |
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET |
APPLIED MEDICAL |
JESSICA CHO |
K111981 |
10/12/2012 |
TREGOR DUAL MOBILITY ACETABULAR SYSTEM |
ASTON MEDICAL |
CATHERINE GLOSTER |
K122078 |
10/31/2012 |
LOFRIC PRIMO, LOFRIC HYDRO-KIT |
ASTRA TECH, INC. |
Allison C Komiyama |
K120199 |
10/12/2012 |
GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY |
BECKMAN COULTER, INC |
BEVERLY HARDING |
K122838 |
10/17/2012 |
LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
K122472 |
10/26/2012 |
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
JACKIE BUCKLEY |
K121002 |
10/12/2012 |
ETEST CEFTAROLINE |
BIOMERIEUX, INC. |
JENNIFER CHIA-HSUAN LIN |
K122547 |
10/15/2012 |
GRAM POSTITVE CLINDAMYCIN |
BIOMERIEUX, INC. |
ELIZABETH LANDON |
K122277 |
10/22/2012 |
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
K121624 |
10/12/2012 |
BIOMET MICROFIXATION NEURO PLATING SYSTEM |
BIOMET MICROFIXATION |
SHERYL MALMBERG |
K122989 |
10/24/2012 |
BIOMET LATERAL SPACER SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
MARGARET F CROWE |
K121973 |
10/30/2012 |
BIOPRO HEMI-EDGE TOE SYSTEM |
BIOPRO, INC. |
AL LIPPINCOTT |
K113650 |
10/03/2012 |
ORTHOFIX SCREW |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
JUAN TEZAK |
K121754 |
10/10/2012 |
BLUE SUI SLING |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
K122924 |
10/24/2012 |
CRE FIXED WIRE BALLON DILATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JANIS F TARANTO |
K123024 |
10/26/2012 |
TORQUE DEVICE |
Boston Scientific Corporation |
RACHEL OWENS |
K122856 |
10/17/2012 |
CHARTER GUIDEWIRE |
BRIVANT, LTD. |
KENNETH WALSH |
K120093 |
10/05/2012 |
BTL ELITE |
BTL INDUSTRIES, INC |
Marcy Moore |
K120728 |
10/22/2012 |
PHASIX PLUG AND PATCH |
C.R. BARD INC |
SHERMA WINSTON |
K122984 |
10/22/2012 |
ATLAS GOLD PTA DILATATION CATHETER |
C.R. BARD, INC. |
JENNIFER LOGVIN |
K120785 |
10/25/2012 |
OMNI 3 OXYGEN SYSTEM |
CAIRE, INC. |
BRIAN JARRELL |
K121768 |
10/31/2012 |
COSENSE |
Capnia, Inc. |
Julie Blacklock |
K122956 |
10/25/2012 |
FUSELOX LUMBAR INTERBODY FUSION DEVICE |
CAPTIVA SPINE |
RICH JANSEN |
K122332 |
10/16/2012 |
TOWERLOX PEDICLE SCREW SYSTEM |
CAPTIVA SPINE |
RICH JANSEN |
K122241 |
10/24/2012 |
IMAGEN3D |
CARDIOVASCULAR IMAGING TECHNOLOGIES |
MELANIE HASEK |
K122987 |
10/25/2012 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
MAUREEN MCDONNELL |
K122422 |
10/24/2012 |
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER |
CAREFUSION |
JOY GREIDANUS |
K121849 |
10/18/2012 |
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE |
CAREFUSION |
JOY GREIDANUS |
K122523 |
10/23/2012 |
CARESTREAM VUE PACS |
CARESTREAM HEALTH, INC. |
Alexandra Chamberlain |
K122215 |
10/26/2012 |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
CARTICEPT MEDICAL, INC. |
Tanya Eberle |
K122463 |
10/11/2012 |
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
K122314 |
10/31/2012 |
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
K121758 |
10/09/2012 |
CERNER FETALINK+(VERSION1.0) |
CERNER CORP. |
SHELLEY S LOOBY |
K120706 |
10/04/2012 |
NIRVANA A PERSONAL LUBRICANT |
CHURCH & DWIGHT CO., INC. |
EMILY PEREZ |
K120751 |
10/03/2012 |
NIRVANA B PERSONAL LUBRICANT |
CHURCH & DWIGHT CO., INC. |
EMILY PEREZ |
K121317 |
10/12/2012 |
COCHLEAR BAHA IMPLANT SYSTEM |
COCHLEAR AMERICAS |
SEAN BUNDY |
K121458 |
10/01/2012 |
SPEEDICATH COMPACT SET (12/18 FR) |
COLOPLAST A/S |
BRIAN SCHMIDT |
K121457 |
10/02/2012 |
SPEEDICATH COMPACT SET (12 FR) |
COLOPLAST CORP. |
BRIAN SCHMIDT |
K122478 |
10/31/2012 |
MODIFIED TREVO RETRIEVER |
CONCENTRIC MEDICAL, INC. |
CHRISTINA ROWE |
K120595 |
10/12/2012 |
UNISYN PLUS HIP STEM |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
K122972 |
10/24/2012 |
CDC ZIRCONIA BLANKS |
CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL |
JERRY DOVIACK, CDT |
K122796 |
10/11/2012 |
CXI SUPPORT CATHETER |
COOK, INC. |
MOLLY BUSENBARK |
K121728 |
10/05/2012 |
TIGER SPINE SYSTEM |
CORELINK LLC |
J.D. WEBB |
K122099 |
10/05/2012 |
BENCOX II STEM, BENCOX METAL HEAD |
CORENTEC CO., LTD |
J.S. DANIEL |
K121563 |
10/05/2012 |
CORIN TRIFIT TS HIP |
CORIN USA |
LUCINDA GERBER |
K123109 |
10/23/2012 |
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE |
COVIDIEN |
RENEE BORGESANO |
K122531 |
10/09/2012 |
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T |
COVIDIEN |
TED KUHN |
K123066 |
10/16/2012 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
ELIZABETH MCMENIMAN |
K122280 |
10/23/2012 |
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM |
CYDEN LIMITED |
AUSTIN SPEIER |
K121287 |
10/03/2012 |
HT-WEDGE |
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L |
SUSAN PAVELKO |
K122445 |
10/12/2012 |
AESPIRE 7900, AESPIRE VIEW |
DATEX-OHMEDA |
JAMES RASKOB |
K122331 |
10/15/2012 |
CAVITY VARNISH |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K122123 |
10/02/2012 |
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
JULIE VAFIDES |
K122395 |
10/31/2012 |
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
MEGAN BURNS |
K121862 |
10/31/2012 |
REX ANTERIOR CERVICAL PLATE SYSTEM |
DIO MEDICAL CO., LTD. |
APRIL LEE |
K122499 |
10/18/2012 |
AIRCAST VENAFLOW ELITE SYSTEM |
DJO, LLC |
KEN FISHER |
K121881 |
10/18/2012 |
DOMAIN SURGICAL SYSTEM |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
K121845 |
10/19/2012 |
SDX SYSTEM |
DYN'R SAS |
TIM LAWTON |
K122574 |
10/12/2012 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
K122858 |
10/03/2012 |
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II |
ELITECHGROUP |
DEBRA K HUTSON |
K113219 |
10/19/2012 |
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
JOHN MCLNTYRE |
K113726 |
10/05/2012 |
EPOC CHLORIDE TEST AND EPOC CREATININE TEST |
EPOCAL, INC. |
ROY LAYER |
K112121 |
10/31/2012 |
ERGOSELECT/GE |
ERGOLINE GMBH |
ANDREA PECSI |
K122511 |
10/01/2012 |
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH |
ETHICON ENDO-SURGERY, LLC |
EMILY KRUETZKAMP |
K123141 |
10/25/2012 |
ENSEAL TRIO TISSUE SEALING DEVICE |
ETHICON ENDO-SURGERY, LLC |
EMILY KREUTZKAMP |
K122798 |
10/11/2012 |
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL |
EXACTECH, INC. |
AMY TAULBEE |
K121684 |
10/01/2012 |
NOVATION LPI PRIME FEMORAL STEM |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
K121597 |
10/02/2012 |
ESON NASAL MASK |
FISHER & PAYKEL HEALTHCARE LIMITED |
JAMES THOMPSON |
K121722 |
10/11/2012 |
ESA620 ELECTRICAL SAFETY ANALYZER |
FLUKE BIOMEDICAL |
JOHN NELSON |
K122694 |
10/25/2012 |
GE 8CH FOOT ANKLE COIL |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
GLEN SABIN |
K122921 |
10/05/2012 |
C1-6-D ULTRASOUND TRANSDUCER |
GE HEALTHCARE |
BRYAN BEHN |
K122114 |
10/03/2012 |
LOGIQ S7 EXPERT, LOGIQ S7 PRO |
GE HEALTHCARE |
BRYAN BEHN |
K120125 |
10/03/2012 |
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
ROBIN MARTIN |
K120641 |
10/17/2012 |
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE |
GLOBAL MEDI PRODUCTS |
ROBERT O DEAN |
K121732 |
10/31/2012 |
CANOPY LAMINOPLASTY FIXATION SYSTEM |
GLOBUS MEDICAL INC. |
SARAH MARIE FITZGERALD |
K122226 |
10/01/2012 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
MERIAM YOUSSEF |
K122028 |
10/23/2012 |
AURICAL HIT |
GN OTOMETRICS |
DANIEL KAMM |
K122262 |
10/25/2012 |
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM |
HAEMONETICS CORP. |
ERICA DIAZ |
K121993 |
10/25/2012 |
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT |
HEIDELBERG ENGINEERING GMBH |
DIANE HORWITZ, PH.D. |
K120947 |
10/17/2012 |
THS INSTRUMENT TRAY |
HOLOGIC, INC. |
SARAH FAIRFIELD |
K122308 |
10/01/2012 |
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
STEPHANIE M FITTS |
K122325 |
10/26/2012 |
SKINTEMP II |
HUMAN BIOSCIENCES, INC. |
JACK SLOVICK |
K113020 |
10/25/2012 |
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
K122465 |
10/16/2012 |
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
K121581 |
10/17/2012 |
BOX PEEK VBR SYSTEM, |
INNOVASIS, INC. |
MARSHALL C MCCARTY |
K121682 |
10/04/2012 |
ACTIVE SCREW BONE SCREW |
INTELLIGENT IMPLANT SYSTEMS, LLC |
MICHAEL J NUTT |
K113706 |
10/17/2012 |
ENDOWRIST STAPLER SYSTEM |
INTUITIVE SURGICAL, INC. |
MEGHNA SRIDHARAN |
K121921 |
10/25/2012 |
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS |
INTUITIVE SURGICAL, INC. |
CHERECE L JONES |
K120053 |
10/18/2012 |
IPS E.MAX PRESS - ABUTMENT SOLUTIONS |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
K122697 |
10/05/2012 |
PORTA 100HF |
JOB CORPORATION |
TAKAHIRO HARUYAMA |
K120499 |
10/05/2012 |
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
K121883 |
10/11/2012 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
Shannon Scott |
K121047 |
10/04/2012 |
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD |
Priscilla Chung |
K122025 |
10/09/2012 |
BRIGHTGLASS BRIGHTGLASS M |
KTK MEDICAL SUPPLIES GMBH |
THOMAS LOTTERMOSER |
K121980 |
10/19/2012 |
ZIRPRIME |
KURARAY NORITAKE DENTAL INC. |
IVAN WASSERMAN |
K122050 |
10/22/2012 |
CPRMETER CPR FEEDBACK DEVICE |
LAERDAL MEDICAL A/S |
DAN DILLION |
K120998 |
10/01/2012 |
SOLSTICE CROSS CONNECTOR |
LIFE SPINE |
RANDY LEWIS |
K121083 |
10/11/2012 |
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA |
LOMA VISTA MEDICAL |
TIFFINI DIAGE |
K122131 |
10/17/2012 |
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY) |
MATANG MFG. SDN. BHD. |
LESLIE LEONG |
K122589 |
10/05/2012 |
DFP4343C7 |
MDI CONSULTANTS, INC. |
JIGAR SHAH |
K122911 |
10/19/2012 |
VERSAFITCUP CC TRIO EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K113678 |
10/01/2012 |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
ADRIENNE LENZ |
K122497 |
10/15/2012 |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM |
MEDICAL DESIGN LLC. |
KRISTI VONDRA |
K121716 |
10/05/2012 |
TBS INSIGHT |
MEDIMAPS GROUP SA |
CHRISTOPHE LELONG |
K122023 |
10/04/2012 |
MIXJECT WITH SPRAY HEAD |
MEDIMOP MEDICAL PROJECTS, LTD. |
LLANIT GOLDGRABER |
K120460 |
10/01/2012 |
SMARTLUX |
MEDMIX CO., LTD |
PETER CHUNG |
K122896 |
10/18/2012 |
COUGAR LS 15 LATERAL CAGE SYSTEM |
MEDOS INTERNATIONAL SARL |
KIRSTEN LEHMULLER |
K122916 |
10/19/2012 |
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM |
MEDRAD, INC. |
BRIT BAIRD |
K122092 |
10/23/2012 |
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM |
MEDRANGE CORPORATION |
KUOFANG HUANG |
K120930 |
10/26/2012 |
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING |
MEDTRADE PRODUCTS LTD. |
CLAIRE RYAN |
K122913 |
10/19/2012 |
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 |
MEDTRONIC INC. |
MARY E DONLIN |
K122811 |
10/12/2012 |
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE |
MEDTRONIC INC. |
JACQUELINE A HAUGE |
K122862 |
10/03/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
K122434 |
10/31/2012 |
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL |
MEDTRONIC XOMED |
ANTOINE KOUCHAKJY |
K122231 |
10/04/2012 |
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
APRIL LEE |
K121962 |
10/19/2012 |
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B |
MEGO AFEK AC LTD |
ALEX RAPEL |
K122384 |
10/04/2012 |
MINISPIR |
MIR MEDICAL INTL. RESEARCH SRL |
GERDA VAN HOUTS |
K122450 |
10/03/2012 |
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
YOICHI WAKIYAMA |
K112826 |
10/10/2012 |
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR |
MOOR INSTRUMENTS LTD. |
XIABING HUANG HUANG |
K111588 |
10/26/2012 |
LEGACY-500 |
MT TABLES, LLC |
MILBURN TENNIS |
K122882 |
10/18/2012 |
NMI HPICC III |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
K120831 |
10/12/2012 |
ANCHORSURE |
NEOMEDIC INTERNATIONAL S.L. |
JEFFREY R SHIDEMAN |
K121551 |
10/23/2012 |
RESOLUTE FACET SCREW SYSTEM |
NEUROSTRUCTURES, LLC |
MEREDITH MAY |
K121931 |
10/19/2012 |
NONDISPOSABLE STIMULATING INSTRUMENTS |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
K122031 |
10/09/2012 |
NEXTRA TI HAMMERTOE CORRECTION SYSTEM |
NEXTREMITY SOLUTIONS, LLC |
ARTHUR A ALFARO |
K113471 |
10/18/2012 |
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
K113469 |
10/18/2012 |
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
K113470 |
10/17/2012 |
NIPRO SAFE TOUCH HUBER INFUSION SET |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
K122012 |
10/04/2012 |
Z-MED Z-MED II |
NUMED, INC. |
NICHELLE LAFLESH |
K121815 |
10/23/2012 |
NUVASIVE SAGE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
K122910 |
10/11/2012 |
ARCHON ANTERIOR CERVICAL PLATE SYSTE, |
NUVASIVE, INCORPORATED |
Cynthia Adams |
K122267 |
10/02/2012 |
GIRAFFE AND PANDA WARMERS |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., |
AGATA ANTHONY |
K121564 |
10/16/2012 |
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 |
OLYMPUS MEDICAL SYSTEMS CORP. |
LAURA STORMS-TYLER |
K122085 |
10/17/2012 |
STINGRAY CERVICAL CAGE |
OMNI SURGICAL, LP DBA SPINE360 |
DAVE LAMB |
K120765 |
10/24/2012 |
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES |
Ortho-Clinical Diagnostics, Inc. |
GAOZHEN HANG |
K122533 |
10/23/2012 |
OSSEOFLEX SB INFLATABLE BONE TAMP |
OSSEON THERAPEUTICS, INC. |
KEITH BURGER |
K120951 |
10/03/2012 |
SMARTBUILDER SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
K122178 |
10/11/2012 |
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
K122837 |
10/15/2012 |
AUTOJECT 2 FOR GLASSY SYRINGE |
OWEN MUMFORD, LTD. |
DARREN MANSELL |
K122971 |
10/25/2012 |
CLICKFINE PEN NEEDLE |
P/L Biomedical |
Lee Leichter |
K122969 |
10/25/2012 |
CLICKFINE PEN NEEDLE |
P/L Biomedical |
Lee Leichter |
K122009 |
10/03/2012 |
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER |
PANASONIC HEALTHCARE CO., LTD. |
RAM BEDI |
K122756 |
10/02/2012 |
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING |
PENUMBRA, INC. |
SETH SCHULMAN |
K123043 |
10/25/2012 |
IRMA C02 MODEL 200101; IRMA AX 200601 |
PHASEIN AB |
DAVID WEISSBURG |
K121781 |
10/26/2012 |
ECHONAVIGATOR RELEASE 1 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
FRANS JACOBS |
K122600 |
10/11/2012 |
LIFEPAK 1000 DEFIBRILLATOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
K122293 |
10/12/2012 |
PIONEER STERNAL CABLE PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
K112217 |
10/16/2012 |
ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER |
POLICHEM S.A. |
JOHN NYGAARD |
K121688 |
10/12/2012 |
MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM |
PRISMATIK DENTALCRAFT, INC. |
KATHLEEN DRAGOVICH |
K122843 |
10/05/2012 |
MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
PRODIGY TECHNOLOGY CONSULTANT CO., LTD. |
ANGUS HSU |
K120110 |
10/04/2012 |
ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET |
PROFIT POINT MANUFACTURING SDN BHD |
ROBERT HILL |
K121657 |
10/23/2012 |
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR |
PROTON SYSTEMS |
MIKE BEGALA |
K122149 |
10/17/2012 |
QBTES |
QBTECH AB |
HANS BOSTROM |
K112139 |
10/26/2012 |
THE CANARY SYSTEM |
QUANTUM DENTAL TECHNOLOGIES INC |
JOSH SILVERTOWN |
K113867 |
10/19/2012 |
LACRICATH LACRIMAL DUCT CATHETER |
QUEST MEDICAL, INC. |
AMY CLENDENING-WHEELER |
K122642 |
10/26/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
Martin Gabler |
K121696 |
10/11/2012 |
WIRELESS THERMOMETER |
RALING MEDICAL COMPANY |
WU WEI |
K122173 |
10/19/2012 |
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC |
RAYENCE CO., LTD |
DAVE KIM |
K122348 |
10/15/2012 |
QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW |
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
MANH-QUYNH CHU |
K122292 |
10/24/2012 |
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
K122003 |
10/26/2012 |
RENEW INSERT |
RENEW MEDICAL, INC. |
VICTORIA MACKINNON |
K121705 |
10/23/2012 |
GEO |
RESMED LTD. |
JIM CASSI |
K122769 |
10/09/2012 |
REMSTAR SE |
RESPIRONICS, INC. |
FRANK KADI |
K121631 |
10/05/2012 |
SIMPLE T NASAL MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
K121344 |
10/17/2012 |
NU SLEEP |
RH ASSOCIATES LLC |
DANIELA LEVY |
K121679 |
10/11/2012 |
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
MIKE FLIS |
K122228 |
10/03/2012 |
LIGAFIX INTERFERENCE SCREW |
SBM SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
K120545 |
10/23/2012 |
HX-461 |
SEERS TECHNOLOGY CO, LTD |
PETER CHUNG |
K120652 |
10/12/2012 |
RAPICIDE OPA-28 TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
K120420 |
10/18/2012 |
STERILE BLUNT FOR SINGLE USE |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
Diana Hong |
K122712 |
10/25/2012 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
K121672 |
10/01/2012 |
AFT PROXIMAL HUMERUS FRACTURE PLATE |
SHOULDER OPTIONS, INC. |
JOHN KAPITAN |
K122074 |
10/12/2012 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
CINDY DOMECUS |
K122599 |
10/03/2012 |
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
KIRA GORDON |
K122398 |
10/12/2012 |
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS |
Siemens Healthcare Diagnostics Inc. |
Amy Goldberg |
K123001 |
10/26/2012 |
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
K122737 |
10/03/2012 |
GEMINUS FOSSA SPECIFIC PLATE SYSTEM |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
K122139 |
10/16/2012 |
SMITH & NEPHEW R3 CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
MARTIN OSTMANN |
K113039 |
10/05/2012 |
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
K121627 |
10/15/2012 |
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
K123012 |
10/24/2012 |
SMITH & NEPHEW SMF HIP STEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
K121861 |
10/18/2012 |
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N |
SMITH & NEPHEW, INC. |
KARIN DESJARDINS |
K122170 |
10/19/2012 |
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION |
SMITH & NEPHEW, INC. |
Bradley Heil |
K122844 |
10/17/2012 |
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
K122168 |
10/11/2012 |
VISUALIF CHALLENGING ACCESS PLATE |
SPINE SMITH PARTNERS L.P. |
CLIFTON NAIVAR |
K122233 |
10/11/2012 |
CAPSURE(R) PS SYSTEM |
SPINE WAVE, INC. |
JOSEPH MERCADO |
K122366 |
10/04/2012 |
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE |
SPINEART |
FRANK PENNESI |
K121201 |
10/26/2012 |
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
K122876 |
10/31/2012 |
MULTIFLEX TINNITUS TECHNOLOGY |
STARKEY LABORATORIES |
KEN MEYER |
K122773 |
10/09/2012 |
CROSS-OVER ACETABULAR SHELL & LINER |
STELKAST COMPANY |
DAVID STUMPO |
K120040 |
10/05/2012 |
REPROCESSED SURGICAL ELECTRIC INSTRUMENT |
STERILMED, INC. |
JASON SKRAMSTED |
K120745 |
10/19/2012 |
XN CAL |
Streck |
DEBORAH S KIPP |
K120747 |
10/22/2012 |
XN CAL PF |
Streck |
DEBORAH S KIPP |
K120742 |
10/19/2012 |
XN CHECK |
Streck |
DEBORAH S KIPP |
K120744 |
10/19/2012 |
XN CHECK BF |
Streck |
DEBORAH S KIPP |
K122313 |
10/31/2012 |
STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM |
Stryker |
ROB YAMASHITA |
K122284 |
10/24/2012 |
HOFFMANN 3 |
STRYKER CORP. |
ESTELA CELI |
K122053 |
10/24/2012 |
SHAPEMATCH CUTTING GUIDE |
STRYKER CORP. |
TAMMY WHARTON |
K120869 |
10/25/2012 |
ANCHOR-L LUMBAR CAGE |
STRYKER SPINE |
TIFFANI ROGERS |
K121637 |
10/25/2012 |
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE |
SUNWELL BIOTECH CO., LTD |
CHARLIE MACK |
K120796 |
10/26/2012 |
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER |
SUPERDIMENSION INC. |
KARYL HASKELL |
K122898 |
10/22/2012 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
K120127 |
10/26/2012 |
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM |
SWAN VALLEY MEDICAL, INCORPORATED |
KEVIN RANDALL |
K121598 |
10/12/2012 |
ME HAIR2GO |
SYNERON MEDICAL LTD. |
JANICE M HOGAN |
K112605 |
10/19/2012 |
SYSMEX XN-SERIES |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
K121579 |
10/03/2012 |
EK DELIVERY DEVICE |
TDAK MEDICAL, INC |
GREG HOLLAND |
K121411 |
10/02/2012 |
SHIGA TOXIN CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
DONNA T LINK |
K121364 |
10/02/2012 |
SHIGA TOXIN QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
DONNA T LINK |
K121594 |
10/25/2012 |
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
K121591 |
10/11/2012 |
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
K121796 |
10/11/2012 |
WECK REUSABLE OBTURATOR |
Teleflex Medical, Inc. |
HOLLY KORNEGAY |
K121636 |
10/24/2012 |
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT |
TGM MEDICAL, INC. |
PRAKASH PAI |
K120116 |
10/01/2012 |
SERF ABLATION SYSTEM SERF ABLATION NEEDLE |
THERMEDICAL |
JANICE M HOGAN |
K121561 |
10/26/2012 |
FLOW2, SWING |
THYSSENKRUPP ACCESSIBILITY B.V. |
ARNOLD HEIDEN |
K122289 |
10/24/2012 |
IMAGE-COM 5.0 |
TOM TEC IMAGING SYSTEMS GMBH |
BERNHARD MUMM |
K122842 |
10/09/2012 |
RADREX-I, SW V4.00 MODEL DRAD-3000E |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
CHARLEMAGNE CHUA |
K121076 |
10/09/2012 |
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
CHARLEMAGNE CHUA |
K122299 |
10/25/2012 |
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR |
TRANSENTERIX, INC. |
TAMMY B CARREA |
K120891 |
10/01/2012 |
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
K121700 |
10/02/2012 |
ULTHERA SYSTEM |
ULTHERA, INC. |
SUZON LOMMEL |
K121652 |
10/05/2012 |
CVUE ADVANCED HYDRA VUE |
UNILENS CORP., USA |
ALAN J FRAZER |
K122504 |
10/10/2012 |
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
K112837 |
10/09/2012 |
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) |
VILEX, INC. |
SYLVIA SOUTHARD |
DEN090012 |
10/18/2012 |
VIRULITE COLD SORE MACHINE |
VIRULITE LLC |
BEKY PINE |
K113786 |
10/26/2012 |
SPERMFREEZE SOLUTION |
VITROLIFE SWEDEN AB |
NINA ARVIDSSON |
K121312 |
10/24/2012 |
INTRAMEDULLARY NAIL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
K120192 |
10/16/2012 |
DISPOSABLE SURGICAL GOWNS |
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
Diana Hong |
K122816 |
10/09/2012 |
AXCESS SOFT TIP WIRE GUIDE |
WILSON-COOK MEDICAL INC. |
DORIS A HAWKS |
K122382 |
10/22/2012 |
DYNASTY BIOFOAM SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DEAN NACHTRAB |
K121425 |
10/01/2012 |
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
K121651 |
10/12/2012 |
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
K122778 |
10/11/2012 |
PROFEMUR Z REVISION HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DEAN NACHTRAB |
K122163 |
10/31/2012 |
CERTEX SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
K120832 |
10/23/2012 |
FORTEX PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
K121992 |
10/16/2012 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR |
XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., |
FRANK LIU |
K122482 |
10/22/2012 |
TRANSTEK WRIST BLOOD PRESSURE MONITOR |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
K121709 |
10/19/2012 |
ZFX DENTAL CAD SYSTEM |
ZIMMER DENTAL INC. |
CECILIA SILVA |
K123019 |
10/22/2012 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS |
ZIMMER, INC. |
REBECCA BROOKS |
K121543 |
10/11/2012 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
K120406 |
10/26/2012 |
ZOLL FULLY AUTOMATIC AED PLUS |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
TANMAY B SHUKLA |