FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K113601 |
12/05/2011 |
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM |
AAP IMPLANTATE AG |
MARC SEEGERS |
K113602 |
12/05/2011 |
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM |
AAP IMPLANTATE AG |
MARC SEEGERS |
K113648 |
12/12/2011 |
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF |
AAP IMPLANTATE AG |
MARC SEEGERS |
K113652 |
12/12/2011 |
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T |
AAP IMPLANTATE AG |
MARC SEEGERS |
K113704 |
12/16/2011 |
ARCHITECT HAVAB-G |
ABBOTT LABORATORIES |
JUDITH WALLACH |
K113719 |
12/19/2011 |
SAFETY SCREW CONNECTOR |
ABBOTT LABORATORIES |
ELIZABETH M ZOLA |
K113658 |
12/12/2011 |
AMPLATZER VASCULAR PLUG 4 |
AGA MEDICAL CORP. |
SHERRY KOLLMANN |
K113810 |
12/23/2011 |
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES |
ALMA LASERS INC. |
TATIANA EPSTEIN |
K113849 |
12/29/2011 |
HQS INTRODUCER |
ALSEAL |
JEAN-FRANCOIS DELFORGE |
K113779 |
12/22/2011 |
CONELOG IMPLANT SYSTEM |
ALTATEC GMBH |
LINDA SCHULZ |
K113555 |
12/01/2011 |
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
AM USA |
KAREN THOMISON |
K113639 |
12/09/2011 |
C2 MEDICAL GLOVES |
AMERCARE, INC. |
ANDREW LOWERY |
K113744 |
12/20/2011 |
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) |
ANGIOTECH |
KIRSTEN STOWELL |
K113800 |
12/23/2011 |
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE |
ANGIOTECH |
KIRSTEN STOWELL |
K113785 |
12/23/2011 |
ADHERENT VISUAL STIMULATOR GOGGLES |
ANSCHEL TECHNOLOGY, INC. |
GLEN PARK |
K113805 |
12/23/2011 |
FIXATE TISSUE BAND |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
K113547 |
12/01/2011 |
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
K113569 |
12/02/2011 |
APNEARX |
APNEA SCIENCE CORPORATION |
GARY MOCNIK |
K113762 |
12/21/2011 |
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
K113716 |
12/19/2011 |
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K113812 |
12/23/2011 |
ATAL-8 |
ATLAIM |
DANIEL KAMM |
K113831 |
12/27/2011 |
PRIMUS HEARING INSTRUMENT TEST UNIT |
AUDITDATA A/S |
DAN HAUGBOL |
K113836 |
12/28/2011 |
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) |
AVERY DENNISON BELGIE, BVBA |
JERZY WOJCIK |
K113838 |
12/28/2011 |
WILDCAT CATHETER |
AVINGER, INC. |
SEVRINA CIUCCI |
K113703 |
12/16/2011 |
BAUSCH + LOMB NESOFILCON A CONTACT LENS |
BAUSCH & LOMB INCORPORATED |
Barbara Klube-Falso |
K113852 |
12/29/2011 |
BAUSCH & LOMB IOL INJECTOR |
BAUSCH & LOMB, INC. |
JASON SMITH |
K113558 |
12/01/2011 |
BD BACTEC PLUS AEROBIC/F (PLASTIC) |
Becton, Dickinson and Company |
Paul Swift |
K113791 |
12/22/2011 |
B-GENIN, R-GENIN |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
K113610 |
12/06/2011 |
ANA-SCREEN WITH MDSS |
Bio-Rad Laboratories |
Juang Wang |
K113858 |
12/30/2011 |
MEGABEAM ENDO-ENT PROBE |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K113792 |
12/23/2011 |
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K113709 |
12/19/2011 |
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K113688 |
12/15/2011 |
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K113783 |
12/22/2011 |
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
ELIZABETH LANDON |
K113645 |
12/12/2011 |
REGENEROSS ALLOGRAFT PLUS MINERLIZED |
BIOMET INTERPORE CROSS |
KATHLEEN OLIVARES |
K113550 |
12/01/2011 |
VANGUARD COMPLETE KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
GARY BAKER |
K113593 |
12/05/2011 |
NEXTGEN ALTIUS OCT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY |
K113764 |
12/21/2011 |
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA |
BIONOSTICS, INC. |
RANDY BYRD |
K113822 |
12/27/2011 |
QUADRASPHERE 30 TO 60 |
BIOSPHERE MEDICAL, INC. |
LINDA J VARROSO |
K113832 |
12/27/2011 |
SONICEYE ULTRASOUND TRANSDUCER |
BLACKTOE MEDICAL III, INC. |
KENDRA RATHKEY |
K113650 |
12/12/2011 |
ORTHOFIX SCREW |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
JUAN TEZAK |
K113681 |
12/15/2011 |
GLADIATOR PTA BALLOON DILATION CATHETER |
BOSTON SCIENTIFIC |
AMBER JOHNSON |
K113651 |
12/12/2011 |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
Boston Scientific Corporation |
HARLAN JONES |
K113732 |
12/19/2011 |
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
K113866 |
12/30/2011 |
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX |
BRENNEN MEDICAL, LLC |
KENNETH B HERLAND |
K113589 |
12/05/2011 |
BIGBOSS CATHETER |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
K113811 |
12/23/2011 |
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
ANASTASIA C RANDALL |
K113808 |
12/23/2011 |
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) |
C.R. BARD, INC. |
HENRY BOLAND |
K113835 |
12/27/2011 |
DATACAPTOR SYSTEM |
CAPSULE TECH INC. |
PETER KELLEY |
K113707 |
12/16/2011 |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
TATYANA BOGDAN |
K113854 |
12/29/2011 |
PLEURX PERITONEAL CATHETER SYSTEM |
CAREFUSION |
JOY GREIDANUS |
K113813 |
12/23/2011 |
SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
K113842 |
12/28/2011 |
CATHETER CONNECTIONS' DUALCAP SOLO |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
K113628 |
12/08/2011 |
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES |
CATHETER ROBOTICS INC |
JENNIFER ENGLUND |
K113618 |
12/07/2011 |
CLEARCORRECT SYSTEM |
CLEARCORRECT, INC. |
CHERYL FISHER |
K113731 |
12/19/2011 |
ESENSOR RESPIRATORY VIRAL PANEL |
CLINICAL MICRO SENSORS, INC. |
JOEL CENTENO |
K113585 |
12/05/2011 |
NASAL/EPISTAXIS PACK |
COGENT THERAPEUTICS, LLC |
ANNE WORDEN |
K113757 |
12/21/2011 |
ASPIRE MAX ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
SHAWN P FOJTIK |
K113634 |
12/09/2011 |
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
COOK IRELAND LTD |
LAURA GUINANE |
K113759 |
12/21/2011 |
AVAIRA (ENFILCON A) CONTACT LENS |
COOPERVISION, INC. |
KARIN GASTINEAU |
K113572 |
12/02/2011 |
LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
JOHN VAN HOVEN |
K113738 |
12/20/2011 |
CREODENT SOLIDEX CUSTOM ABUTMENT |
CREODENT PROSTHETICS LTD. |
CALVIN SHIM |
K113660 |
12/13/2011 |
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL |
CRYOTHERAPY PRODUCTS INC. |
JORGE CABALLERO |
K113548 |
12/01/2011 |
PEDCAT |
CURVEBEAM, LLC |
DAVID W COWAN |
K113543 |
12/01/2011 |
ONDEMAND3D |
CYBERMED, INC. |
YONG KI IM |
K113787 |
12/22/2011 |
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
DEFIBTECH, LLC |
Ed Horton |
K113545 |
12/01/2011 |
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
K120014 |
12/29/2011 |
STA- COAG CONTROL (N+ABN) PLUS |
DIAGNOSTICA STAGO, INC. |
KEVIN WYCKOFF |
K113798 |
12/23/2011 |
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET |
Draeger Medical Systems, Inc. |
BETH A ZIS |
K113689 |
12/15/2011 |
DUKAL LUBRICATING JELLY |
DUKAL CORPORATION |
PATRICK J LAMB |
K113796 |
12/23/2011 |
SOLITAIRE-C CERVICAL SPACER SYSTEM |
EBI, LLC |
MARGARET CROWE |
K113623 |
12/05/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
K113653 |
12/12/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
K113667 |
12/13/2011 |
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING |
EDWARDS LIFESCIENCES, LLC. |
KAREN JONES |
K113565 |
12/02/2011 |
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN |
EDWARDS LIFESCIENCES, LLC. |
MARGUEITE THOMLINSON |
K113562 |
12/01/2011 |
3MP COLOR LCD MONITOR, RADIFORCE RX340 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K113784 |
12/22/2011 |
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K113844 |
12/28/2011 |
RADIFORCE RX240 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K113695 |
12/16/2011 |
ELLIPSE PRECICE TRAUMA NAIL SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
JOHN MCLNTYRE |
K113756 |
12/21/2011 |
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K113726 |
12/19/2011 |
EPOC CHLORIDE TEST AND EPOC CREATININE TEST |
EPOCAL, INC. |
ROY LAYER |
K113767 |
12/21/2011 |
MOUNTED MEDICAL OXYGEN SYSTEM |
ESSEX INDUSTRIES, INC. |
KEN SEISE |
K113576 |
12/05/2011 |
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
K113743 |
12/20/2011 |
EVOLUTION 3E VENTILATOR |
EVENT MEDICAL, INC. |
RICK WATERS |
K113609 |
12/06/2011 |
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
K113564 |
12/02/2011 |
EXSALT T7 WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
MELANIE USSYK |
K113761 |
12/21/2011 |
INFRARED THERMOMETER |
FAMIDOC TECHNOLOGY CO., LTD |
LEON CAO |
K113702 |
12/16/2011 |
FOTONA XP ND: YAG LASER SYSTEM |
FOTONA D.D. |
STOJAN TROST |
K113591 |
12/05/2011 |
COLS PEEK |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
K113713 |
12/19/2011 |
GEN_2 MECHANICAL WHEELCHAIR |
FREE WHEELCHAIR MISSION |
SHARON ROCKWELL |
K113722 |
12/19/2011 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
K113750 |
12/21/2011 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
K113710 |
12/19/2011 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
K113749 |
12/21/2011 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
K113797 |
12/23/2011 |
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
K113790 |
12/23/2011 |
DISPOSABLE VINYL EXAM GLOVE, POWDERED |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABTEH DENG |
K113860 |
12/30/2011 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
AMY MCKINNEY |
K113816 |
12/27/2011 |
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV |
GC AMERICA, INC. |
CARL H JENKINS |
K113690 |
12/15/2011 |
GE LOGIQ I, LOGIQ E AND VIVID E |
GE HEALTHCARE |
BRYAN BEHN |
K113758 |
12/21/2011 |
VOLUSON E6/E8/E8EXPERT/E10 |
GE HEALTHCARE |
BRYAN BEHN |
K113607 |
12/06/2011 |
BIOPSY DIGIT S BIOPSY SL |
GIOTTO USA, LLC |
NICOLAAS BESSELING |
K113853 |
12/29/2011 |
G+ SYSTEM |
GLYTEC, LLC |
WILLIAM MATTHEWS |
K113847 |
12/29/2011 |
BORRELIA BURGDORFERI IGG BLOT TEST |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
K113846 |
12/29/2011 |
BORRELIA BURGDORFERI IGM BLOT TEST |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
K113833 |
12/27/2011 |
VITAL SIGNS MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
Diana Hong |
K113624 |
12/08/2011 |
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K113674 |
12/14/2011 |
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT |
HANDPIECE HEADQUARTERS INC. - HPR INC. |
TINA STEFFANIE-OAK |
K113728 |
12/19/2011 |
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY |
HANS BIOMED CORP. |
PATSY J TRISLER |
K113622 |
12/08/2011 |
ORION II CT CVC |
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
NOLA BENSTOG |
K113837 |
12/28/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. |
RICHARD LU |
K113574 |
12/02/2011 |
FLEXITIME MONOPHASE PRO SCAN |
HERAEUS KULZER, LLC |
CHRIS HOLDEN |
K113575 |
12/02/2011 |
HILLA DIGITAL TRANSFERS |
HILLA TECHNOLOGIES, INC. |
CAROLYN M PRIMUS |
K113809 |
12/23/2011 |
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERICKA B AMMIRATI |
K113683 |
12/15/2011 |
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL |
HOSPIRA,INC. |
KAREN KEENER |
K113769 |
12/22/2011 |
GPSCATH BALLON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES |
Eric Ankerud |
K113760 |
12/21/2011 |
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
VALERIE GIAMBANCO |
K113662 |
12/07/2011 |
FENESTRATED NERVE BLOCK NEEDLE |
IMD INC |
WALTER ZOHMANN |
K113855 |
12/29/2011 |
PANORAD, PANORAD SL |
IMIX ADR FINLAND OY |
DANIEL KAMM |
K113748 |
12/21/2011 |
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) |
IMRIS, INC. |
Sanjay Shah |
K113670 |
12/13/2011 |
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
K113863 |
12/30/2011 |
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
K113552 |
12/01/2011 |
FREEDOM INGUINAL HERNIA IMPLANT |
Insightra Medical |
Wayne Noda |
K113644 |
12/12/2011 |
PILOT TUBE REPAIR KIT |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
K113570 |
12/02/2011 |
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP |
INTEGRA BURLINGTON MA, INC. |
LINDSAY MIGNONE |
K113541 |
12/01/2011 |
CLEARSTART SVM SYSTEM |
INTIO INC. |
DAVID GUSTAFSON |
K113620 |
12/07/2011 |
MYRIAN 1.11 |
INTRASENSE |
FREDERIC BANEGAS |
K113706 |
12/16/2011 |
ENDOWRIST STAPLER SYSTEM |
INTUITIVE SURGICAL, INC. |
MEGHNA SRIDHARAN |
K113697 |
12/16/2011 |
EIGR SURGICAL ILLUMINATION SYSTEM |
INVUITY, INC. |
THERESA BRANDNER-ALLEN |
K113862 |
12/30/2011 |
ZIO PATCH |
IRHYTHM TECHNOLOGIES, INC. |
MICHAEL RIGHTER |
K113654 |
12/12/2011 |
CASPIAN |
K2M, INC. |
NANCY GIEZEN |
K113685 |
12/15/2011 |
POWDER FREE LATEX EXAMINATION GLOVES |
KHAI HOAN JOINT STOCK COMPANY |
TERENCE LIM |
K113806 |
12/23/2011 |
KIMGUARD ONE STEP STERILIZATION WRAP |
KIMBERLY-CLARK HEALTH CARE |
CHRISTOPHER B SWANSON |
K113559 |
12/01/2011 |
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS |
LDR SPINE USA INC. |
KIERSTEN SODERMAN |
DEN110019 |
12/08/2011 |
NEBA SYSTEM |
LEXICOR MEDICAL TECHNOLOGY, LLC |
E. HOWARD MERRY |
K113566 |
12/02/2011 |
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM |
LIFE TECHNOLOGIES, INC. |
KELLI L TANZELLA |
K113661 |
12/13/2011 |
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
K113830 |
12/27/2011 |
VANTERA CLINICAL ANALYZER |
LIPOSCIENCE |
SUZETTE WARNER |
K113616 |
12/07/2011 |
ACCUDXA2 |
LONE OAK MEDICAL TECHNOLOGIES, LLC |
DAVID COMLEY |
K113843 |
12/28/2011 |
FREEDOM ND: YAG LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
K113668 |
12/13/2011 |
HEALITE II SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
K113588 |
12/05/2011 |
SPECTRA LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
K113679 |
12/14/2011 |
LUCEA LED SURGICAL LIGHT SYSTEM |
MAQUET SAS |
WHITNEY TORNING |
K113596 |
12/05/2011 |
MASIMO SET REUSABLE OXIMETRY SENSORS |
MASIMO CORPORATION |
DAVID COLLETTE |
K113739 |
12/20/2011 |
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM |
MATERIALISE DENTAL NV |
GEERT APPELTANS |
K113599 |
12/05/2011 |
SURGICASE CONNECT |
MATERIALISE N.V. |
Alexandra Razzhivina |
K113829 |
12/27/2011 |
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE |
MATERIALISE N.V. |
Alexandra Razzhivina |
K113621 |
12/08/2011 |
SMARTDRIVE WHEELCHAIR POWER-ASSIST |
MAX MOBILITY, LLC |
WILLIAM M RICHTER |
K113664 |
12/13/2011 |
CLOSER TO NATURE ELECTRIC BREAST PUMP |
MAYBORN GROUP LIMITED |
NEIL HEWITT |
K113686 |
12/15/2011 |
KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED |
MAYER LABORATORIES, INC. |
DAVID P MAYER |
K113633 |
12/08/2011 |
MCKESSON ANESTHESIA CARE |
MCKESSON TECHNOLOGIES INC. |
JANICE M HOGAN |
K113571 |
12/02/2011 |
GMK RESUFACING PATELLA SIZE 4 |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K113678 |
12/14/2011 |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
ADRIENNE LENZ |
K113673 |
12/13/2011 |
MYSAFETY SYRINGE |
MEDICALCHAIN INTERNARTIONAL CORPORATION |
ROBIN HWANG |
K113583 |
12/05/2011 |
CURAD ANTIBACTERIAL BANDAGE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K113677 |
12/14/2011 |
GRINDCARE MEASURE |
MEDOTECH A/S |
Calley Herzog |
K113828 |
12/27/2011 |
DYNANAIL ANKLE ARTHRODESIS NAIL |
MEDSHAPE, INC |
JEREMY BLAIR |
K113560 |
12/01/2011 |
CELOX GAUZE PRO |
MEDTRADE PRODUCTS LTD. |
CLAIRE RYAN |
K113845 |
12/28/2011 |
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE |
MEDTRONIC INC. |
KEVIN T LAM |
K113642 |
12/12/2011 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
K113577 |
12/05/2011 |
MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
K113701 |
12/16/2011 |
VISIA NEURO |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
K113698 |
12/16/2011 |
SCEPTER XC OCCLUSION BALLOON CATHETER |
MICRO VENTION, INC. |
Naomi Gong |
K113597 |
12/05/2011 |
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES |
MINILAP TECHNOLOGIES |
ALLAN ALWARD |
K113655 |
12/12/2011 |
TI-MAX X TURBINE |
NAKANISHI, INC. |
DIANE RUTHERFORD |
K113717 |
12/19/2011 |
ULTRASONIC SCALER |
NAKANISHI, INC. |
DIANE RUTHERFORD |
K113712 |
12/19/2011 |
IM-11 PNEUMATIC MICROINJECTOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K113638 |
12/09/2011 |
NMI 2.8 MICROCATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
K113554 |
12/01/2011 |
CMI IMPLANT IS SYSTEM |
NEOBIOTECH CO., LTD. |
APRIL LEE |
K113733 |
12/19/2011 |
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
KEVIN A THOMAS |
K113771 |
12/22/2011 |
SIGNAL GEAR URETHRAL CATHETER ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
K113763 |
12/21/2011 |
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
MARIA HATEGAN |
K113795 |
12/23/2011 |
SUCTION LIPOLASTY ACCESSORIES |
NORMAN M. BLACK III |
NORMAN BLACK |
K113820 |
12/27/2011 |
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER |
NOVABAY PHARMACEUTICALS |
SHEILA W PICKERING |
K113608 |
12/06/2011 |
DEFLEX |
NUXEN S.R.L. |
HERNAN ILARI |
K113788 |
12/22/2011 |
DEFLEX ACRILATO |
NUXEN S.R.L. |
HERNAN ILARI |
K113687 |
12/15/2011 |
EQUINOX RELIEVE |
O-TWO MEDICAL TECHNOLOGIES, INC. |
David Zhang |
K113725 |
12/19/2011 |
VIRTUOST |
O.N. DIAGNOSTICS |
DAVID KOPPERDAHL |
K113696 |
12/16/2011 |
OPTOS ADVANCE |
OPTOS PLC |
HOWARD M HOLSTEIN |
K113869 |
12/30/2011 |
ORIGEN REINFORCED DUAL LUMEN CATHETER |
Origen Biomedical, Inc. |
RICHARD MARTIN |
K113627 |
12/08/2011 |
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON |
ROSEMARY HARRY |
K113770 |
12/22/2011 |
ORTHOFIX GALAXY FIXATION SYSTEM |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
K113708 |
12/16/2011 |
ORTHOSCAN MOBILE DI MINI C-ARM |
ORTHOSCAN, INC. |
CHRIS EAVES |
K113582 |
12/05/2011 |
ARCHSTENT BILIARY SYSTEM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
K113775 |
12/22/2011 |
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
K113594 |
12/05/2011 |
C-THV SYSTEM |
PAIEON, INC. |
EREZ BEN-ZVI |
K113724 |
12/19/2011 |
ELECTROPULSE-COSMETIC |
PAIN RELIEF TECHNOLOGIES |
KENDALL GORHAM |
K113612 |
12/06/2011 |
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A |
PANASONIC HEALTHCARE CO., LTD. |
RAM BEDI |
K113781 |
12/22/2011 |
PANTHEON SPINAL IBFD SYSTEM |
PANTHEON SPINAL |
SCOTT SPANN |
K113625 |
12/08/2011 |
DSS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
MICHELLE MCDONOUGH |
K113730 |
12/19/2011 |
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
K113839 |
12/28/2011 |
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE |
PARKELL, INC. |
DANIEL R SCHECHTER |
K113568 |
12/02/2011 |
MTA-FILLAPEX |
PAXMED INTERNATIONAL |
ALLISON KOMIYAMA |
K113819 |
12/27/2011 |
MONGOOSE ANGIOGRAPHIC CATHETER |
PEDIACATH INC. |
CAROLINE TONTINI |
K113873 |
12/30/2011 |
PENTAX EPK-I5020 VIDEO PROCESSOR |
PENTAX OF AMERICA, INC. |
ROBERT SCHIFF |
K113841 |
12/28/2011 |
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
PHADIA US INC. |
MARTIN MANN |
K113657 |
12/12/2011 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MANFRED STEVER |
K113636 |
12/09/2011 |
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) |
PHILOSYS CO. LTD. |
LINDA CHAN |
K113807 |
12/23/2011 |
DEXERYL CREAM |
PIERRE FABRE MEDICAL DEVICES |
DIANE MANDELL HORWITZ |
K113705 |
12/16/2011 |
PINTLER PATIENT WARMING SYSTEM |
PINTLER MEDICAL |
MARIBETH MACINTYRE-ELLIS |
K113544 |
12/01/2011 |
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER |
PROSPERA CORPORATION |
Kevin Walls |
K113772 |
12/22/2011 |
HPR EMOLLIENT FOAM |
PRUGEN IP HOLDINGS, INC |
SEAN LONERGAN |
K113774 |
12/22/2011 |
HPR PLUS EMOLLIENT FOAM |
PRUGEN IP HOLDINGS, INC |
SEAN LONERGAN |
K113818 |
12/27/2011 |
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL |
PULPDENT CORPORATION |
KENNETH J BERK |
K113711 |
12/19/2011 |
LIME-LITE II |
PULPDENT CORPORATION |
KENNETH J BERK |
K113617 |
12/07/2011 |
SPEE-DEE PATCH |
PULPDENT CORPORATION |
KENNETH J BERK |
K113867 |
12/30/2011 |
LACRICATH LACRIMAL DUCT CATHETER |
QUEST MEDICAL, INC. |
AMY CLENDENING-WHEELER |
K113777 |
12/21/2011 |
QUIDEL MOLECULAR INFLUENZA A+B |
QUIDEL CORP. |
Ronald H Lollar |
K113747 |
12/20/2011 |
RANDOX OPIATES ASSAY |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
K113751 |
12/21/2011 |
RANDOX COCAINE METABOLITE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K113720 |
12/19/2011 |
RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K113630 |
12/08/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA |
RAYENCE CO., LTD |
DAVE KIM |
K113656 |
12/12/2011 |
CAREGUIDE OXIMETER |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
K113801 |
12/22/2011 |
VPAP ADAPT |
RESMED CORP |
DAVID D D'CRUZ |
K113640 |
12/09/2011 |
STELLAR 150 |
RESMED GERMANY INC. |
DAVID D'CRUZ |
K113780 |
12/22/2011 |
EASYCARE TX SYSTEM (CONNEXUNS) |
RESMED LTD. |
DAVID D'CRUZ |
K113815 |
12/23/2011 |
RESSCAN |
RESMED LTD. |
DAVID D'CRUZ |
K113714 |
12/19/2011 |
VPAP TX |
RESMED LTD. |
DAVID D'CRUZ |
K113793 |
12/23/2011 |
HOMOCYSTEINE TEST |
ROCHE |
Susan Hollandbeck |
K113614 |
12/06/2011 |
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
MICHAEL FLIS |
K113546 |
12/01/2011 |
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 |
Roche Diagnostics |
Michael Leuther |
K113542 |
12/01/2011 |
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) |
SALTER LABS, ARVIN FACILITY |
MICHAEL SHOUP |
K113755 |
12/21/2011 |
SAVANNAH TECHNOLOGIES SPINAL SYSTEM |
SAVANNAH TECHNOLOGIES LLC |
J.D. WEBB |
K113549 |
12/01/2011 |
COMFORT COUGH |
SEOIL PACIFIC CORP. |
Priscilla Chung |
K113693 |
12/16/2011 |
NIXALL TM WOUND AND SKIN CARE |
SERIOUSLY CLEAN LTD |
KIP GLASS |
K113742 |
12/20/2011 |
KMC KYPHOPLASTY SYSTEM |
SHANGHAI KINETIC MEDICAL CO., LTD |
GREGORY MATHISON |
K113613 |
12/06/2011 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
FLOWER CAI |
K113587 |
12/05/2011 |
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) |
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
CHARLIE MACK |
K113865 |
12/30/2011 |
PULTOL |
SHARP CORPORATION |
DIANE RUTHERFORD |
K113727 |
12/19/2011 |
SHENZHEN MED-LINK PULSE OXIMETER PROBE |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
RHONDA ALEXANDER |
K113647 |
12/12/2011 |
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
K113632 |
12/05/2011 |
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
K113789 |
12/22/2011 |
MODULAR PROXIMALLY FLUTED HIP STEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
K113848 |
12/29/2011 |
R3 XLPE LINERS |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
K113700 |
12/16/2011 |
VIAVALVE SAFETY IV CATHETER |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
K113752 |
12/21/2011 |
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
LOUISE FOCHT |
K113680 |
12/15/2011 |
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT |
SOMA ACCESS SYSTEMS LLC |
GENOA ATWOOD |
K113626 |
12/08/2011 |
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
K113584 |
12/05/2011 |
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER |
ST. JUDE MEDICAL |
BRYAN COWELL |
K113611 |
12/06/2011 |
RAPID PROGRAMMER |
ST. JUDE MEDICAL |
TERI GILIO |
K113773 |
12/22/2011 |
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL |
ST. JUDE MEDICAL |
GEENA GEORGE |
K113606 |
12/06/2011 |
NNC GOLD ABUTMENT FOR BRIDGES |
STRAUMANN USA |
ELAINE ALAN |
K113598 |
12/05/2011 |
POWER-LOAD COT FASTENER SYSTEM |
STRYKER MEDICAL |
RENATA SILA |
K113778 |
12/22/2011 |
EXCELSIOR XT-27 MICROCATHETER |
STRYKER NEUROVASCULAR |
YOKO Y ENRILE |
K113802 |
12/23/2011 |
ESCALATE LAMINOPLASTY SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K113666 |
12/13/2011 |
XIA 3 SPINAL SYSTEM |
STRYKER SPINE |
G. STIEGMAN |
K113737 |
12/20/2011 |
SUREFIRE GUIDE SHEATH |
SUREFIRE MEDICAL, INC |
MARIO ARBESU |
K113776 |
12/22/2011 |
FLASHPAK |
SYMMETRY MEDICAL |
ROBERT JOHNSON |
K113857 |
12/30/2011 |
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE |
SYNERGETICS, INC |
GARY OLIVEROS |
K113586 |
12/05/2011 |
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
K113868 |
12/30/2011 |
EPLUS SKIN TREATMENT SYSTEM |
SYNERON, LTD. |
YORAM LEVY |
K113600 |
12/05/2011 |
IM BAND |
SYNEXMED (SHENZHEN) COMPANY LIMITED |
ERIC CHIEN |
K113567 |
12/02/2011 |
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
SYNTHES INC |
ALAN T HALEY |
K113551 |
12/01/2011 |
ESOPHAGEAL TTS STENT |
TAEWOONG MEDICAL CO., LTD |
STEPHEN RHODES |
K113768 |
12/21/2011 |
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
MEIRU LI |
K113721 |
12/19/2011 |
TEPHAFLEX LIGHT MESH |
TEPHA, INC. |
MARY P LEGRAW |
K113723 |
12/19/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
MARY P LEGRAW |
K113823 |
12/27/2011 |
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
K113699 |
12/16/2011 |
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED |
THE PROCTER & GAMBLE COMPANY |
KATHLEEN BLIESZNER |
K113715 |
12/19/2011 |
LUNG VOLUME ANALYSIS |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
K113821 |
12/27/2011 |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
K113663 |
12/13/2011 |
SONIXTABLET ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
K113754 |
12/21/2011 |
CFR QUANT |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON |
K. LANCE GOULD |
K113766 |
12/21/2011 |
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K113672 |
12/13/2011 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
K113872 |
12/30/2011 |
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
K113786 |
12/22/2011 |
SPERMFREEZE SOLUTION |
VITROLIFE SWEDEN AB |
NINA ARVIDSSON |
K113871 |
12/30/2011 |
PRO-DENSE BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
K113692 |
12/15/2011 |
XENX |
XENOLITH MEDICAL |
OFER ZIGMAN |
K113753 |
12/21/2011 |
ZIMMER DENTAL TAPERED SCREW-VENT X |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
K113718 |
12/19/2011 |
NCB STRAIGHT NARROW SHAFT PLATES |
ZIMMER GMBH |
STEPHEN H MCKELVEY |
K113556 |
12/01/2011 |
WAGNER CONE PROSTHESIS SYSTEM |
ZIMMER GMBH |
DANIEL J WILLIAM |
K113561 |
12/01/2011 |
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |