| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K110457 |
02/17/2011 |
3M TEGADERM MATRIX DRESSING |
3M COMPANY |
MARIA RUIZ |
| K110302 |
02/02/2011 |
ADHESIVE EXL-759 |
3M ESPE AG |
DESI W SOEGIARTO |
| K110508 |
02/22/2011 |
SUGLUE-10 |
3M ESPE AG |
DESI W SOEGIARTO |
| K110471 |
02/18/2011 |
BABI PLUS INFANT NASAL CANNULA SYSTEM |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| K110383 |
02/10/2011 |
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| 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 |
| K110381 |
02/10/2011 |
CELL-DYN EMERALD 22 SYSTEM |
ABBOTT LABORATORIES |
MICHELLE B ROEDING |
| K113719 |
12/19/2011 |
SAFETY SCREW CONNECTOR |
ABBOTT LABORATORIES |
ELIZABETH M ZOLA |
| K110458 |
02/17/2011 |
SILVER ANTIMICROBIAL WOUND GEL |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K110432 |
02/15/2011 |
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K113658 |
12/12/2011 |
AMPLATZER VASCULAR PLUG 4 |
AGA MEDICAL CORP. |
SHERRY KOLLMANN |
| K110503 |
02/22/2011 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) |
AIRSTRIP TECHNOLOGIES, LP |
ANDY MILLER |
| 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 |
| K110328 |
02/03/2011 |
ACG-8511 PORTABLE ECG MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K110330 |
02/03/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| 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 |
| K110345 |
02/04/2011 |
SCANVIEW SYSTEM |
APPLIED SPECTRAL IMAGING |
DAN LAOR |
| 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 |
| K110553 |
02/28/2011 |
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE |
ASAHI INTECC USA, INC. |
YOSHI TERAI |
| K110481 |
02/18/2011 |
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE |
ASI MEDICAL, INC. |
JOHN MCPEEK |
| K110356 |
02/07/2011 |
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT |
ASTRA TECH, INC. |
BETSY A BROWN |
| 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 |
| K110559 |
02/28/2011 |
AVITA INFRARED THEROMETER WITH BLUETOOTH |
AVITA CORPORATION |
JENNIFER REICH |
| K110296 |
02/01/2011 |
AXIS-SHIELD ANTI-CCP |
AXIS-SHIELD DIAGNOSTICS, LTD. |
CLAIRE I DORA |
| 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 |
| K110413 |
02/14/2011 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K110443 |
02/16/2011 |
BD INSYTE AUTOGUARD BC |
BECTON DICKINSON & CO. |
RAND PUGMIRE |
| K113558 |
12/01/2011 |
BD BACTEC PLUS AEROBIC/F (PLASTIC) |
Becton, Dickinson and Company |
Paul Swift |
| K110434 |
02/15/2011 |
TRIXEL CO2 LASER |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
| K113791 |
12/22/2011 |
B-GENIN, R-GENIN |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K110350 |
02/07/2011 |
KNEEHAB XP |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| 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 |
| K110449 |
02/16/2011 |
ENDOBON XENOGRAFT GRANULES |
BIOMET 3I |
MARTHA I GARAY |
| K110565 |
02/28/2011 |
ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K113645 |
12/12/2011 |
REGENEROSS ALLOGRAFT PLUS MINERLIZED |
BIOMET INTERPORE CROSS |
KATHLEEN OLIVARES |
| K110555 |
02/28/2011 |
ARCOMXL ACTIVE ARTICULATION |
BIOMET MANUFACTURING CORP. |
BEKCY EARL |
| K110320 |
02/03/2011 |
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K110400 |
02/11/2011 |
TAPERLOC COMPLETE MICROPLASTY STEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K110362 |
02/08/2011 |
VANGUARD ASYMMETRICAL PATELLAR COMPONENT |
BIOMET MANUFACTURING CORP. |
TAMARA WEST |
| 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 |
| K110461 |
02/17/2011 |
SELECTRA CS LEAD INTRODUCER SYSTEM |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K110426 |
02/14/2011 |
DYNA-EXTOR II |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K113832 |
12/27/2011 |
SONICEYE ULTRASOUND TRANSDUCER |
BLACKTOE MEDICAL III, INC. |
KENDRA RATHKEY |
| K110375 |
02/09/2011 |
BLUESHINE'S GOLD SERIES |
BLUESHINE SRL |
CHIARA RICCI |
| 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 |
| K110479 |
02/18/2011 |
ACUITY WHISPER VIEW GUIDE WIRES |
BOSTON SCIENTIFIC CORP. |
KIRSTIN JOHNSTON |
| K110295 |
02/01/2011 |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
BOSTON SCIENTIFIC CORP. |
SHANNON PETTIT |
| 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 |
| K110305 |
02/02/2011 |
CRY-ACTRACKERCAM |
BRYMILL CRYOGENIC CYSTEMS |
CLAUDIO RUSSO |
| K113811 |
12/23/2011 |
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
ANASTASIA C RANDALL |
| K110396 |
02/11/2011 |
ASPIRA PERITONEAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
| K110409 |
02/14/2011 |
ASPIRA PLEURAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
| K113808 |
12/23/2011 |
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) |
C.R. BARD, INC. |
HENRY BOLAND |
| K110395 |
02/11/2011 |
C.T.M. MOBILITY SCOOTER - MODEL HS 118 |
C.T.M. HOMECARE PRODUCT, INC. |
SHEILA RAMERMAN |
| K110567 |
02/28/2011 |
C.T.M. MOBILITY SCOOTER HS515(3W) |
C.T.M. HOMECARE PRODUCT, INC. |
SHEILA RAMERMAN |
| K113835 |
12/27/2011 |
DATACAPTOR SYSTEM |
CAPSULE TECH INC. |
PETER KELLEY |
| K110499 |
02/22/2011 |
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL LTD. |
CLAY ANSELMO |
| K110493 |
02/22/2011 |
TANDEMHEART PUMP |
CARDIACASSIST INC. |
ROBERT BOLLINGER |
| K113707 |
12/16/2011 |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
TATYANA BOGDAN |
| K110389 |
02/10/2011 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
MEGAN M BRANDT |
| K113854 |
12/29/2011 |
PLEURX PERITONEAL CATHETER SYSTEM |
CAREFUSION |
JOY GREIDANUS |
| K110535 |
02/25/2011 |
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION |
CAREFUSION 303,INC. |
GABRIELA MURANEVICI |
| 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 |
| K110554 |
02/28/2011 |
BIOCERAMIC ORBITAL IMPLANT, ORBTEX |
CERAMISYS LTD. |
HILLARD W WELCH |
| K110332 |
02/03/2011 |
CLEARCANVAS RIS / PACS |
CLEARCANVAS INC. |
CLINTON CHAU |
| 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 |
| K110297 |
02/01/2011 |
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
TAN KENG BENG |
| K110483 |
02/18/2011 |
MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K110542 |
02/24/2011 |
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW HULL |
| K113757 |
12/21/2011 |
ASPIRE MAX ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
SHAWN P FOJTIK |
| K110402 |
02/11/2011 |
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER |
COOK BIOTECH, INC. |
PERRY W GUINN |
| K113634 |
12/09/2011 |
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
COOK IRELAND LTD |
LAURA GUINANE |
| K110347 |
02/07/2011 |
DOPPLER MONITOR |
COOK VASCULAR, INC. |
JIM FERGUSON |
| K113759 |
12/21/2011 |
AVAIRA (ENFILCON A) CONTACT LENS |
COOPERVISION, INC. |
KARIN GASTINEAU |
| K110321 |
02/03/2011 |
TIGER SPINE SYSTEM |
CORELINK, LLC |
J.D. WEBB |
| K110404 |
02/14/2011 |
EAUM TOTAL KNEE SYSTEM |
CORENTEC CO., LTD |
KEVIN A THOMAS |
| 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 |
| K110531 |
02/24/2011 |
ENDOFLIP ECD |
CROSPON, LTD. |
PAUL DRYDEN |
| K110529 |
02/24/2011 |
ENDOFLIP GASTRIC TUBE |
CROSPON, LTD. |
PAUL DRYDEN |
| 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 |
| K110511 |
02/23/2011 |
E4D COMPASS |
D4D TECHNOLOGIES |
Allison Scott |
| 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 |
| K110397 |
02/11/2011 |
TRUMATCH PERSONALIZED SOLUTIONS |
DEPUY ORTHOPAEDICS, INC. |
NANCY S FRIDDLE |
| K110353 |
02/07/2011 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
LUKE BULINO |
| K110546 |
02/25/2011 |
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY |
DERMA SCIENCES, INC. |
RONALD S WARREN |
| K120014 |
12/29/2011 |
STA- COAG CONTROL (N+ABN) PLUS |
DIAGNOSTICA STAGO, INC. |
KEVIN WYCKOFF |
| K110384 |
02/10/2011 |
DILON 6800 ACELLA (ACELLA) |
DILON TECHNOLOGIES, INC. |
ELAINE DUNCAN |
| K110439 |
02/15/2011 |
DOMAIN SURGICAL SYSTEM |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K110364 |
02/07/2011 |
DORNIER MEDILAS D LITEBEAM+ 1470 |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| 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 |
| K110521 |
02/23/2011 |
EVERON CENTRAL DISPLAY STATION (CDS) |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| 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 |
| K110393 |
02/11/2011 |
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W |
EKF-DIAGNOSTIC GMBH |
STEPHEN GORSKI |
| 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 |
| K110373 |
02/08/2011 |
TEMPOROMANIBULAR COIL 15 |
ESAOTE S.P.A. |
DONATELLA RAGGHIANTI |
| K113767 |
12/21/2011 |
MOUNTED MEDICAL OXYGEN SYSTEM |
ESSEX INDUSTRIES, INC. |
KEN SEISE |
| K110431 |
02/15/2011 |
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS |
ETHICON ENDO-SURGERY |
THOMAS BOSTICCO |
| K110385 |
02/10/2011 |
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER |
ETHICON ENDO-SURGERY, INC. |
ASIFA VONHOF |
| K113576 |
12/05/2011 |
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
| K110319 |
02/03/2011 |
EVERCROSS 0.035 OTW PTA DILATATION CATHETER |
EV3 INC |
PAULA CORDERO |
| K113743 |
12/20/2011 |
EVOLUTION 3E VENTILATOR |
EVENT MEDICAL, INC. |
RICK WATERS |
| K110509 |
02/22/2011 |
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K110547 |
02/25/2011 |
OPTERTRAK LOGIC PSC TIBIAL INSERT |
EXACTECH SARASOTA |
PATRICK HUGHES |
| 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 |
| K110288 |
02/01/2011 |
FEMVUE SALINE-AIR DEVICE |
FEMASYS INC. |
LISA PEACOCK |
| K110541 |
02/25/2011 |
FIGURE 8 STERNOTOMY CLOSURE DEVICE |
FIGURE 8 SURGICAL, INCORPORATED |
KIT CARIQUITAN |
| K110316 |
02/03/2011 |
INFOSEND GSM |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K110429 |
02/15/2011 |
PROSIM 4, PROSIM 6, PROSIM 8 |
FLUKE BIOMEDICAL |
JOHN NELSON |
| K110333 |
02/03/2011 |
NATURALASE CO2 LASER SYSTEM |
FOCUS MEDICAL, LLC. |
JOHN LEE |
| 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 |
| K110436 |
02/15/2011 |
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA |
FUJIREBIO DIAGNOSTICS, INC |
KENT PRUETT |
| 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 |
| K110518 |
02/23/2011 |
IBAG |
FUTURE PATH MEDICAL, LLC |
DANIEL KAMM |
| 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 |
| K110558 |
02/28/2011 |
CS1000 LIGHT THERAPY DEVICE |
GENESIS HEALTH LIGHT CORPORATION |
PAUL ZIEMER |
| 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 |
| K110299 |
02/01/2011 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| 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 |
| K110480 |
02/18/2011 |
PDE PHOTODYNAMIC EYE |
HAMAMATSU PHOTONICS, K.K. |
JEFFREY K SHAPIRO |
| K110390 |
02/11/2011 |
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR |
HANDELSHAUS DITTMAN GMBH |
KANG JIANG PING |
| 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 |
| K110301 |
02/02/2011 |
SILK'N FX |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN PH. D. |
| K110530 |
02/24/2011 |
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL |
HORIBA ABX S.A.S. |
CAROLINE FERRER |
| 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 |
| K110290 |
02/01/2011 |
EXETER HIP STEM |
HOWMEDICA OSTEONICS CORP |
VALERIE GIAMBANCO |
| 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 |
| K110425 |
02/14/2011 |
HC-BIOS DENTAL IMPLANT |
HUNG CHUN BIO-S CO., LTD. |
MICHAEL LEE |
| 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 |
| K110412 |
02/14/2011 |
IDS-ISYS IFG-I CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K113748 |
12/21/2011 |
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) |
IMRIS, INC. |
Sanjay Shah |
| K110369 |
02/08/2011 |
INDISTRIP GREEN |
INDILAB, INC. |
MARK ESPENSCHEID |
| K113670 |
12/13/2011 |
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K110388 |
02/10/2011 |
COLLACARE DENTAL |
INNOCOLL PHARMACEUTICALS LTD |
AARON WYSE |
| K110344 |
02/04/2011 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS |
LARRY LEPLEY |
| 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 |
| K110569 |
02/28/2011 |
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| 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 |
| K110528 |
02/24/2011 |
INTEGRA LED SURGICAL HEADLIGHT SYSTEM |
INTEGRA LIFE SCIENCES CORPORATION |
STEPHANIE SHEESLEY |
| K113541 |
12/01/2011 |
CLEARSTART SVM SYSTEM |
INTIO INC. |
DAVID GUSTAFSON |
| K113620 |
12/07/2011 |
MYRIAN 1.11 |
INTRASENSE |
FREDERIC BANEGAS |
| K110451 |
02/16/2011 |
ENDOWRIST ONE SUCTION/IRRIGATOR |
INTUITIVE SURGICAL, INC. |
BRANDON HANSEN |
| 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 |
| K110454 |
02/16/2011 |
COUGAR LS LATERAL CAGE SYSTEM |
JOHNSON & JOHNSON |
KEVIN G STEVENS |
| K110551 |
02/28/2011 |
EXPEDIUM SPINE SYSTEM |
JOHNSON & JOHNSON |
FRANK JURCZAK |
| K110548 |
02/25/2011 |
OSI O-BALL ABUTMENT HEAD IMPLANTS |
JUELL DENTAL |
ANGELA BLACKWELL |
| K113654 |
12/12/2011 |
CASPIAN |
K2M, INC. |
NANCY GIEZEN |
| K110462 |
02/17/2011 |
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE |
KEPLER MEDTEC |
SHARYN ORTON, PHD |
| K113685 |
12/15/2011 |
POWDER FREE LATEX EXAMINATION GLOVES |
KHAI HOAN JOINT STOCK COMPANY |
TERENCE LIM |
| K110455 |
02/15/2011 |
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS |
KIMBERLY-CLARK CORP. |
ANN WATERHOUSE |
| K113806 |
12/23/2011 |
KIMGUARD ONE STEP STERILIZATION WRAP |
KIMBERLY-CLARK HEALTH CARE |
CHRISTOPHER B SWANSON |
| K110487 |
02/22/2011 |
FLEXIBLE CARDIAC COIL |
LBDS HOLDING COMPANY |
RICHARD BRYANT |
| K110327 |
02/03/2011 |
LDR SPINE ROI-A INTERBODY FUSION SYSTEM |
LDR SPINE USA |
MARITZA ELIAS |
| 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 |
| K110370 |
02/08/2011 |
Q-CLEAR |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
| K113661 |
12/13/2011 |
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K110298 |
02/01/2011 |
OPIATE ENZYME IMMUNOASSAY |
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 |
| K110500 |
02/22/2011 |
STAT-MAT MINOR |
MACPHERSON MEDICAL, INC. |
HOWARD HOLSTEIN |
| 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 |
| K110300 |
02/02/2011 |
SIMPLANT 2011 |
MATERIALISE DENTAL NV |
PETER VANDEPUT |
| K113739 |
12/20/2011 |
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM |
MATERIALISE DENTAL NV |
GEERT APPELTANS |
| K110415 |
02/14/2011 |
SIGNATURE PLANNER / SIGNATURE GUIDES |
MATERIALISE N.V. |
ALEXANDRA RAZZHIVANA |
| 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 |
| K110343 |
02/04/2011 |
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP |
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD |
NEIL HEWITT |
| K113664 |
12/13/2011 |
CLOSER TO NATURE ELECTRIC BREAST PUMP |
MAYBORN GROUP LIMITED |
NEIL HEWITT |
| K110325 |
02/03/2011 |
AQUA LUBE |
MAYER LABORATORIES, INC. |
DAVID P MAYER |
| 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 |
| K110424 |
02/14/2011 |
DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K113678 |
12/14/2011 |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
ADRIENNE LENZ |
| K110377 |
02/09/2011 |
PROTECTIVE RESTRAINT |
MEDI-TECH INTL. CORP. |
MARILYN GEIGER |
| K113673 |
12/13/2011 |
MYSAFETY SYRINGE |
MEDICALCHAIN INTERNARTIONAL CORPORATION |
ROBIN HWANG |
| K110374 |
02/09/2011 |
MAX PULSE SYSTEM |
MEDICORE CO., LTD. |
YOO BYUNG-KUK |
| K110497 |
02/22/2011 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
J.D. WEBB |
| 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 |
| K110386 |
02/10/2011 |
CELOX RAPID GAUZE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K113845 |
12/28/2011 |
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE |
MEDTRONIC INC. |
KEVIN T LAM |
| K110560 |
02/28/2011 |
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K110472 |
02/18/2011 |
SI-FIX SACROILIAC JOINT FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K113642 |
12/12/2011 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
| K110562 |
02/28/2011 |
TELAMON PEEK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
REGINA HOLMES |
| K110543 |
02/25/2011 |
CRESCENT (R) SPINAL SYSTEM TITANIUM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BECKY RONNER |
| K110522 |
02/23/2011 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
NICHOLAS TABRIZI |
| K110284 |
02/01/2011 |
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K110283 |
02/01/2011 |
ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| 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 |
| K110358 |
02/07/2011 |
VENODYNE V810 |
MICROTEK MEDICAL, INC. |
TOM BONNER |
| K113597 |
12/05/2011 |
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES |
MINILAP TECHNOLOGIES |
ALLAN ALWARD |
| K110411 |
02/14/2011 |
ATAMA SYSTEM |
MONTERIS MEDICAL, INC. |
JEFF WILSON |
| K110322 |
02/03/2011 |
OLECRA INTRAMEDULLARY FIXATION SYSTEM |
MYLAD ORTHOPEDIC SOLUTIONS |
SCOTT G EDWARDS |
| K113655 |
12/12/2011 |
TI-MAX X TURBINE |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K113717 |
12/19/2011 |
ULTRASONIC SCALER |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K110442 |
02/16/2011 |
NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM |
NANOVIS, LLC |
KEVIN A THOMAS, PHD |
| 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 |
| K110315 |
02/02/2011 |
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K110445 |
02/16/2011 |
FLEXFUSION (TM) FIXATION IMPLANT |
NEXTREMITY SOLUTIONS, LLC |
ARTHUR A ALFARO |
| K110410 |
02/14/2011 |
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K110376 |
02/09/2011 |
PE-210AK SWITCH BOX |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K113763 |
12/21/2011 |
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
MARIA HATEGAN |
| K110463 |
02/17/2011 |
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) |
NORAV MEDICAL LTD. |
BENRY ARAZY |
| 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 |
| K110368 |
02/08/2011 |
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K110486 |
02/22/2011 |
ACCUSOM |
NOVASOM, INC. |
ROGER K RICHARDSON |
| K110484 |
02/18/2011 |
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
| 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 |
| K110337 |
02/04/2011 |
UNIVERSAL MAXILLARY MOLAR |
OCO BIOMEDICAL |
JACK BLOOM |
| K110294 |
02/01/2011 |
HIGH FLOW INSUFFLATION UNIT UHI-4 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K110501 |
02/22/2011 |
HEM-4030 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K113696 |
12/16/2011 |
OPTOS ADVANCE |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K110309 |
02/02/2011 |
FOB ONE STEP RAPID TEST |
ORIENT GENE BIOTECH |
Gary Lehnus |
| K113869 |
12/30/2011 |
ORIGEN REINFORCED DUAL LUMEN CATHETER |
Origen Biomedical, Inc. |
RICHARD MARTIN |
| K110335 |
02/04/2011 |
CERAMIC BRACKETS |
ORTHO ORGANIZERS, INC. |
FOSTER BOOP |
| 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 |
| K110326 |
02/03/2011 |
OSRAM ITOS |
OSRAM SYLVANIA, INC. |
MARIE A SCHROEDER |
| K110308 |
02/02/2011 |
PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| 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 |
| K110371 |
02/08/2011 |
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY |
PANORAMIC CORP. |
DANIEL KAMM |
| 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 |
| K110430 |
02/14/2011 |
DOLPHIN IMAGING |
PATTERSON DENTAL SUPPLY, INC. |
DAWN LI |
| 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 |
| K110456 |
02/16/2011 |
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM |
PHARMAJET, INC. |
MICHAEL J RYAN |
| K113657 |
12/12/2011 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MANFRED STEVER |
| K110474 |
02/18/2011 |
PHILIPS INTELLIVUE TCG10 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JENS-PETER SEHER |
| K110414 |
02/14/2011 |
QLAB 8.1 QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
NANCY BURKE |
| K113636 |
12/09/2011 |
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) |
PHILOSYS CO. LTD. |
LINDA CHAN |
| K110550 |
02/25/2011 |
BRIGHT EMBRACE MODEL SBL60 |
PHYSICIAN ENGINEERED PRODUCTS, INC. |
ROBERT ROSE |
| 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 |
| K110561 |
02/28/2011 |
FORTROSS BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE |
| K110367 |
02/08/2011 |
PIONEER SPINAL PROCESS FUSION PLATE |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY M DOWNS |
| K110473 |
02/18/2011 |
NANOTACK SUTURE ANCHOR 1.4MM |
PIVOT MEDICAL |
Jon Cook |
| K110491 |
02/22/2011 |
BACKSTOP CATHETER |
PLUROMED, INC. |
JAMES WILKIE |
| K110420 |
02/14/2011 |
OPHIRA MINI SLING SYSTEM |
PROMEDON S.A. |
STEPHANIE RAIS |
| 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 |
| K110392 |
02/11/2011 |
PSM LOMAS / BENEFIT SCREWS |
PSM MEDICAL SOLUTIONS |
ANDREA PECSI |
| 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 |
| DEN110001 |
02/16/2011 |
RIDASCREEN NOROVIRUS 3RD GENERATION EIA |
R-Biopharm AG |
Gary Lehnus |
| K110416 |
02/14/2011 |
ABL835 FLEX ANALYZER WITH PLEURAL PH |
RADIOMETER MEDICAL APS |
SOREN BOGESTRAND |
| K110468 |
02/17/2011 |
FREEWAY COMFORT BITE GUARD |
RANDMARK DENTAL PRODUCTS, LLC |
NORMAN F ESTRIN |
| K110534 |
02/25/2011 |
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| 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 |
| K110566 |
02/28/2011 |
VIBERECT PENILE VIBRATORY STIMULATION DEVICE |
REFLEXONIC, LLC |
CAROLINE TONTINI |
| 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 |
| K110444 |
02/16/2011 |
MIRAGE MICRO |
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 |
| K110293 |
02/01/2011 |
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K110398 |
02/11/2011 |
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS |
RESPIRONICS, INC. |
JOSEPH E OLSAVSKY |
| K110405 |
02/14/2011 |
TRUBLUE NASAL MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| 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 |
| K110446 |
02/16/2011 |
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID |
Roche Diagnostics |
MICHELLE LEE NEFF |
| K110313 |
02/02/2011 |
TINA-QUANT HBA1C GEN.2 |
Roche Diagnostics |
Susan Hollandbeck |
| K113542 |
12/01/2011 |
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) |
SALTER LABS, ARVIN FACILITY |
MICHAEL SHOUP |
| K110304 |
02/02/2011 |
APEX ER. YAG / IPL SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES LLC |
MARK ROHRER |
| K110502 |
02/22/2011 |
TRIPLEX ER. YAG / ND: YAG SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K110495 |
02/22/2011 |
LIFTKAR PT |
SANO TRANSPORTGERATE GMBH |
JEANINE A CARROCCIO |
| K110379 |
02/10/2011 |
AIR-N-GO |
SATELEC |
RICK ROSATI |
| 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 |
| K110366 |
02/07/2011 |
SYNGO.CT CARDIAC FUNCTION |
SIEMENS AG |
RALF HOFFMANN |
| K110303 |
02/01/2011 |
STRATUS CS ACUTE CARE D-DIMER |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN ANN DRAY-LYONS |
| K110494 |
02/22/2011 |
SYNGO MBF |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K110403 |
02/11/2011 |
PROLINK ADHESIVES (PROLINK, PROLINK SE) |
SILMET LTD. |
MOSHE ZALSMAN |
| K110291 |
02/01/2011 |
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| 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 |
| K110545 |
02/25/2011 |
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) |
SMITH & NEPHEW, INC. |
ELIZABETH LAVELLE |
| 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 |
| K110349 |
02/07/2011 |
CLEAR+BRILLIANT LASER SYSTEM |
SOLTA MEDICAL, INC. |
KRISTINE FOSS |
| K113680 |
12/15/2011 |
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT |
SOMA ACCESS SYSTEMS LLC |
GENOA ATWOOD |
| K110510 |
02/22/2011 |
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K113626 |
12/08/2011 |
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K110306 |
02/02/2011 |
SOUND SURGICAL VASER 2.1 LIPO SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
STEPHEN C SMITH |
| K110433 |
02/15/2011 |
CLEARBLUE EASY PREGNANCY TEST |
SPD DEVELOPMENT COMPANY LIMITED |
TANYA FAIR |
| K110507 |
02/22/2011 |
CARDIAC SCANNER AND PROCESSING SYSTEM |
SPECTRUM DYNAMICS (ISRAEL) LTD. |
ILAN SHARON |
| K110428 |
02/14/2011 |
ESCOM 100 |
SPIDENT CO., LTD. |
JE MO AHN |
| K110450 |
02/16/2011 |
AGILIS NXT STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
WENDY PINOR |
| K110549 |
02/25/2011 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| 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 |
| K110407 |
02/14/2011 |
INVISIPORT |
STEALTH THERAPEUTICS, INCORPORATED |
Gary J Syring |
| K110453 |
02/16/2011 |
RELIANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K113606 |
12/06/2011 |
NNC GOLD ABUTMENT FOR BRIDGES |
STRAUMANN USA |
ELAINE ALAN |
| K110476 |
02/18/2011 |
AXSOS (TM) LOCKING PLATE SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K110533 |
02/24/2011 |
STRYKER PATIENT SPECIFIC CUTTING GUIDE |
STRYKER CORP. |
KAREN ARIEMMA |
| 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 |
| K110419 |
02/14/2011 |
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS |
STRYKER SPINE |
TIFFANI D ROGERS |
| 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 |
| K110459 |
02/17/2011 |
SUREFIRE INFUSION CATHETER SYSTEM |
SUREFIRE MEDICAL, INC |
CHERYL HASTINGS |
| 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 |
| K110538 |
02/25/2011 |
PRO FIXATION SYSTEM |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
AMY BOUCLY |
| K113567 |
12/02/2011 |
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
SYNTHES INC |
ALAN T HALEY |
| K110354 |
02/07/2011 |
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM |
SYNTHES USA |
THOMAS N SHEA |
| 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 |
| K110427 |
02/14/2011 |
FEMTEC LASER SYSTEM FOR CAPSULOTOMY |
TECHNOLAS PERFECT VISION GMBH |
BETTY M JOHNSON |
| K110422 |
02/14/2011 |
SURGICAL STIMULATORS |
TECHNOMED EUROPE |
PIERRE VREULS |
| K113721 |
12/19/2011 |
TEPHAFLEX LIGHT MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K113723 |
12/19/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K110698 |
02/17/2011 |
NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K110482 |
02/18/2011 |
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS |
TERATECH CORP. |
CHARLES F HOTTINGER |
| K110527 |
02/24/2011 |
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE |
TERUMO EUROPE N.V. |
M. J AERTS |
| K110540 |
02/25/2011 |
TERUMO SUPPORT CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| 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 |
| K110563 |
02/28/2011 |
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP |
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.) |
JULIE POWELL |
| K110318 |
02/02/2011 |
EXCELLAGEN |
TISSUE REPAIR COMPANY |
LOIS CHANDLER |
| K110520 |
02/23/2011 |
BIOLIS 12I |
TOKYO BOEKI MEDISYS INC. |
James M Clinton |
| K110489 |
02/22/2011 |
SLIT LAMP SL-2G |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
| 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 |
| K110331 |
02/03/2011 |
SENSITITRE AIM (TM) |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
| K110314 |
02/02/2011 |
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) |
TRUE GLOVE FACTORY |
FRANK YANG |
| K110515 |
02/23/2011 |
UCP DRUG SCREENING TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K113663 |
12/13/2011 |
SONIXTABLET ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K110447 |
02/16/2011 |
ECHOINSIGHT |
ULTRASOUND MEDICAL DEVICES, INC. |
PAUL KORTESOJA |
| K110452 |
02/16/2011 |
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, |
UNILENS CORP., USA |
ALAN J FRAZER |
| K113754 |
12/21/2011 |
CFR QUANT |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON |
K. LANCE GOULD |
| K110435 |
02/15/2011 |
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM |
US DIAGNOSTICS, INC. |
JONATHAN JOHNSON |
| 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 |
| K110438 |
02/15/2011 |
SENSILASE PAD-IQ |
VASAMED, INC. |
Gary J Syring |
| K113672 |
12/13/2011 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K110355 |
02/07/2011 |
VENX REVOLUTION |
VENX LLC |
IRA DUESLER |
| K110406 |
02/14/2011 |
CELLTRACKS AUTOPREP SYSTEM |
VERIDEX, LLC |
JESSICA SHELFFO |
| K113872 |
12/30/2011 |
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K110394 |
02/11/2011 |
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K110525 |
02/23/2011 |
VITALOGRAPH MODEL 7100 - VITALOJAK |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K113786 |
12/22/2011 |
SPERMFREEZE SOLUTION |
VITROLIFE SWEDEN AB |
NINA ARVIDSSON |
| K110440 |
02/15/2011 |
QUICK UP |
VOCO GMBH |
DR. T. GERKENSMEIER |
| K110418 |
02/14/2011 |
POWDER FREE NITRILE EXAMINATION GLOVES |
W.A. RUBBERMATE CO., LTD. |
TERENCE LIM SIN KOOI |
| K110334 |
02/04/2011 |
WALDO PATIENT MONITOR |
WALDO HEALTH |
ALAN R WEISS |
| K110516 |
02/23/2011 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
FRED SCHWEITZER |
| K110421 |
02/14/2011 |
DISPOSABLE INSULIN SYRINGE |
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD |
Diana Hong |
| K110556 |
02/28/2011 |
MINI TELEMETRY SYSTEM |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
AGATA SMIEJA |
| K110399 |
02/11/2011 |
GLADIATOR PLASMA CLASSIC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K113871 |
12/30/2011 |
PRO-DENSE BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
| K110360 |
02/08/2011 |
PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K110552 |
02/28/2011 |
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
| K113692 |
12/15/2011 |
XENX |
XENOLITH MEDICAL |
OFER ZIGMAN |
| K110289 |
02/01/2011 |
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE |
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
ZHAI YING CHUAN |
| K110342 |
02/04/2011 |
YOLO CURVE |
YOLO MEDICAL INC. |
ROBERT J KRZNARIC |
| K110312 |
02/02/2011 |
CLICKFINE AUTOPROTECT PEN NEEDLE |
YPSOMED AG |
ANDRE SAUTER |
| K110536 |
02/25/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO TENGYUE PLASTIC PRODUCTS CO., LTD. |
FRANK LIU |
| K110338 |
02/04/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUECHUAN PLASTIC PRODUCTS CO., LTD. |
FRANK LIU |
| 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 |
| K110348 |
02/07/2011 |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K113561 |
12/01/2011 |
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
| K110526 |
02/24/2011 |
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
| K110361 |
02/07/2011 |
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
| K110512 |
02/23/2011 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
