| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K120453 |
03/19/2012 |
FILTEK BULK FILL FLOWABLE RESTORATIVE |
3M ESPE DENTAL PRODUCTS |
SCOTT ERICKSON |
| K111964 |
03/02/2012 |
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K120568 |
03/29/2012 |
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K113151 |
03/08/2012 |
IFS LASER SYSTEM |
ABBOTT MEDICAL OPTICS INC |
KESLEY E GALLAGHER |
| K113464 |
03/06/2012 |
NC TREK OTW CORONARY DILATATION CATHETER |
Abbott Vascular |
SUZANNE REDMAN |
| K120233 |
03/09/2012 |
SYNCHRONY RESPIRATORY TRACKING SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
| K120124 |
03/06/2012 |
FORESIGHT U120 URINE ANALYZER |
ACON LABORATORIES, INC. |
QIYI XIE |
| K112863 |
03/29/2012 |
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN |
ACTA MEDICAL L.L.C. |
AARON COMPTON |
| K112606 |
03/06/2012 |
ACTIVATOR V-E |
ACTIVATOR METHODS INTERNATIONAL LTD. |
ARLAN W FUHR |
| K110662 |
03/12/2012 |
ADAPTIVE WEDGE |
ADAPTIVE SPECIALTY, LLC |
J.D. WEBB |
| K113365 |
03/29/2012 |
INFANT ARRAY |
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS |
RAVI SPRINIVASAN |
| K112568 |
03/01/2012 |
AONGEN DENTAL COLLAGEN MATRIX |
AEON ASTRON EUROPE B.V. |
HORNG JI LAI |
| K112682 |
03/19/2012 |
METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
KATHY A RACOSKY |
| K120120 |
03/15/2012 |
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH |
AGA MEDICAL CORPORATION |
RASHMI BHUSHAN |
| K112977 |
03/27/2012 |
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) |
ALCON RESEARCH, LTD. |
Catherine Goble |
| K112538 |
03/29/2012 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113810 |
03/08/2012 |
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES |
ALMA LASERS INC. |
TATIANA EPSTEIN |
| K120060 |
03/16/2012 |
E-CUBE 9 |
ALPINION MEDICAL SYSTEMS CO., LTD |
YUCHI CHU |
| K113131 |
03/08/2012 |
LIASYS 450 |
AMS |
STEFANO CORRADI |
| K112452 |
03/30/2012 |
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K113547 |
03/28/2012 |
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 |
03/01/2012 |
APNEARX |
APNEA SCIENCE CORPORATION |
GARY MOCNIK |
| K111549 |
03/30/2012 |
ATTUNE SLEEP APNEA SYSTEM |
APNICURE, INC. |
CHRIS DANIEL |
| K120044 |
03/08/2012 |
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED |
ARTHREX, INC. |
COURTNEY SMITH |
| K120540 |
03/20/2012 |
BIOBOLT |
ARTHREX, INC. |
COURTNEY SMITH |
| K120096 |
03/27/2012 |
MULTIFIX P KNOTLESS FIXATION DEVICE |
ARTHROCARE CORPORATION |
CHERYL FREDERICK |
| K113003 |
03/01/2012 |
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... |
ASTRA TECH INC. |
BETSY A BROWN |
| K113420 |
03/16/2012 |
RNARETAIN |
ASURAGEN, INC. |
Luc Van Hove |
| K120273 |
03/30/2012 |
KITTYCAT CATHETER, KITTYCAT 2 CATHETER |
AVINGER, INC. |
Albert Boniske |
| K113838 |
03/12/2012 |
WILDCAT CATHETER |
AVINGER, INC. |
SEVRINA CIUCCI |
| K120660 |
03/15/2012 |
CONQUEST 40 PTA DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
ASHLEY FICKETT |
| K111268 |
03/06/2012 |
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE |
WEIPING ZHONG |
| K110894 |
03/28/2012 |
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER |
BAYER HEALTHCARE |
ROGER SONNENBURG |
| K110587 |
03/28/2012 |
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) |
BAYER HEALTHCARE, LLC |
CHUCK RYAN |
| K111523 |
03/13/2012 |
OSTEOCOOL (TM) RF ABLATION SYSTEM |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K113558 |
03/16/2012 |
BD BACTEC PLUS AEROBIC/F (PLASTIC) |
Becton, Dickinson and Company |
Paul Swift |
| K112774 |
03/28/2012 |
BD RECYKLEEN SHARPS COLLECTORS |
Becton, Dickinson and Company |
EILEEN HILLER |
| K120049 |
03/23/2012 |
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B |
Becton, Dickinson and Company |
Gregory P Payne |
| K113791 |
03/15/2012 |
B-GENIN, R-GENIN |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K103116 |
03/13/2012 |
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K113431 |
03/30/2012 |
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA |
BETTINI S.P.A. |
Claude Berthoin |
| K103834 |
03/30/2012 |
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS |
Bio-Rad Laboratories |
Juang Wang |
| K120439 |
03/14/2012 |
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG |
BIO-RAD LABORATORIES, INC. |
Juang Wang |
| K120572 |
03/26/2012 |
BIOPLEX 2200 TORC IGG |
BIO-RAD LABORATORIES, INC. |
Juang Wang |
| K120504 |
03/27/2012 |
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK |
BIO-RAD LABORATORIES, INC. |
ELIZABETH PLATT |
| K113688 |
03/13/2012 |
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
| K103081 |
03/02/2012 |
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE |
BIOM'UP SAS |
VALERIE CENTIS |
| K120557 |
03/19/2012 |
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 |
BIOMET SPINE & BONE HEALING TECHNOLOGIES |
MARGARET F CROWE |
| K110737 |
03/29/2012 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 |
BIONIME CORPORATION |
JIGAR SHAH |
| K113822 |
03/08/2012 |
QUADRASPHERE 30 TO 60 |
BIOSPHERE MEDICAL, INC. |
LINDA J VARROSO |
| K113832 |
03/06/2012 |
SONICEYE ULTRASOUND TRANSDUCER |
BLACKTOE MEDICAL III, INC. |
KENDRA RATHKEY |
| K111820 |
03/14/2012 |
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE |
BM KOREA CO., LTD. |
Priscilla Chung |
| K120893 |
03/29/2012 |
IMAGER II ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC CORP. |
ANNE V ROSSI |
| K113220 |
03/22/2012 |
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) |
Boston Scientific Corporation |
VICKY L HAGENS |
| K113090 |
03/15/2012 |
LEVEEN SUPERSLIM NEEDLE ELECTRODE |
Boston Scientific Corporation |
ASHLEY PYLE |
| K113866 |
03/23/2012 |
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX |
BRENNEN MEDICAL, LLC |
KENNETH B HERLAND |
| K113811 |
03/16/2012 |
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
ANASTASIA C RANDALL |
| K113808 |
03/19/2012 |
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) |
C.R. BARD, INC. |
HENRY BOLAND |
| K113854 |
03/19/2012 |
PLEURX PERITONEAL CATHETER SYSTEM |
CAREFUSION |
JOY GREIDANUS |
| K112052 |
03/15/2012 |
CAREFUSION NICOLET EDX |
CAREFUSION 209, INC. |
ROBERT BURDGE |
| K110535 |
03/26/2012 |
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION |
CAREFUSION 303,INC. |
GABRIELA MURANEVICI |
| K111423 |
03/02/2012 |
CS 1600 INTRAORAL CAMERA |
CARESTREAM HEALTH,INC. |
DANIEL HOEFER |
| K120154 |
03/21/2012 |
INTRAUTERINE INSEMINATION (IUI) CATHETER |
CATHETER RESEARCH, INC. |
BABACAR DIOUF |
| K111841 |
03/01/2012 |
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD |
XINGLONG TIAN |
| K111501 |
03/23/2012 |
I-LIPO SYSTEM |
CHROMOGENEX TECHNOLOGIES LIMITED |
PETER R BEVAN |
| K113168 |
03/30/2012 |
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K113387 |
03/15/2012 |
CITIEFFE TITANIUM NAILING SYSTEM |
CITIEFFE |
Claude Berthoin |
| K113618 |
03/19/2012 |
CLEARCORRECT SYSTEM |
CLEARCORRECT, INC. |
CHERYL FISHER |
| K112268 |
03/19/2012 |
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR |
CODAN US CORP. |
JEFF NIELSEN |
| K120274 |
03/02/2012 |
DELTAMAXX 18 MICROCOIL SYSTEM |
CODMAN AND SHURTLEFF, INC. |
KIM FONDA |
| K112404 |
03/15/2012 |
CONCENTRIC BALLOON GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K113260 |
03/09/2012 |
MODIFIED CONCENTIRC MICROCATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K113058 |
03/29/2012 |
TIGER SPINE SYSTEM |
CORELINK LLC |
JUSTIN EGGLETON |
| K112077 |
03/09/2012 |
HBIDB - HUMAN BRIAN INDEX SOFTWARE |
CORSCIENCE GMBH & CO. KG |
PATRIK R KAREM |
| K113372 |
03/07/2012 |
NUVANT, MOBILC CARDIAC TELEMETRY |
CORVENTIS, INC. |
KATHLEEN LUNDBERG |
| K111933 |
03/15/2012 |
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 |
COVIDIEN |
Jean Simon |
| K120061 |
03/27/2012 |
WOUND PROTECTOR |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
JOSEPH CANAVAN |
| K113255 |
03/07/2012 |
PUREGRAFT 850/PURE SYSTEM |
CYTORI THERAPEUTICS, INC. |
KENNETH K KLEINHENZ |
| K103329 |
03/13/2012 |
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION |
DELBIO INCORPORATION |
NICKY PAN |
| K112547 |
03/06/2012 |
NEO NEST |
DENOVO PROUCTS LLC |
DALE WALTERS |
| K111663 |
03/12/2012 |
TRAUMA INTERNAL FIXATION SYSTEMS |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K112411 |
03/20/2012 |
MAMMOTOME ELITE BIOPSY SYSTEM |
DEVICOR MEDICAL PRODUCTS INC. |
SHAWNA M ROSE |
| K112755 |
03/27/2012 |
ABACUS 5 |
DIATRON US INC |
MICHAEL SWITZER |
| K111664 |
03/30/2012 |
DIAZYME CYSTATIN C POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K113324 |
03/28/2012 |
REXIOUS HOOK FIXATION SYSTEMS |
DIO MEDICAL CO., LTD. |
APRIL LEE |
| K111947 |
03/01/2012 |
DUET MAGNA |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K103035 |
03/28/2012 |
SMARTPILOT VIEW MODEL MK04500 |
DRAEGER MEDICAL GMBH |
JOYCE KILROY |
| K113798 |
03/22/2012 |
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET |
Draeger Medical Systems, Inc. |
BETH A ZIS |
| K113095 |
03/02/2012 |
E-CARE INFRARED EAR THERMOMETER |
E-CARE TECHNOLOGY CORPORATION |
KIN-YUAN KO |
| K120188 |
03/16/2012 |
ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS INC |
YUE QIUHONG |
| K113478 |
03/05/2012 |
PLIF CAGE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K113784 |
03/02/2012 |
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K113695 |
03/28/2012 |
ELLIPSE PRECICE TRAUMA NAIL SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
JOHN MCLNTYRE |
| K113756 |
03/14/2012 |
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 |
| K113475 |
03/20/2012 |
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K112663 |
03/12/2012 |
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL |
ENHATCH ORTHOPAEDICS LLC |
MICHAEL PHIPPS |
| K113243 |
03/28/2012 |
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K111541 |
03/16/2012 |
ENDO-EXPRESS (R) HANDPIECE |
ESSENTIAL DENTAL SYSTEMS, INC. |
JEFFREY WAN |
| K113320 |
03/16/2012 |
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K111702 |
03/22/2012 |
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
FENWAL, INC. |
Kim Forch |
| K110019 |
03/30/2012 |
RESPIRATORY HUMIDIFER |
FISHER & PAYKEL HEALTHCARE, LTD. |
ADELE BINDON |
| K120304 |
03/01/2012 |
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER |
FOOTPRINT MEDICAL INC. |
CLYDE BAKER |
| K113702 |
03/28/2012 |
FOTONA XP ND: YAG LASER SYSTEM |
FOTONA D.D. |
STOJAN TROST |
| K120505 |
03/06/2012 |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
DENISE OPPERMANN |
| K111703 |
03/29/2012 |
INFRARED EAR THEROMETER |
FUDAKANG INDUSTRIAL CO LTD |
DANIEL NAM |
| K111654 |
03/01/2012 |
FD TENS 2070 |
FUJI DYNAMICS LTD |
CHING KONG (FELIX) LEE |
| K113284 |
03/07/2012 |
BIOPSY POSITIONER |
FUJI FILM MEDICAL SYSTEMS |
KIMERLY A SHARP |
| K113750 |
03/05/2012 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
| K113749 |
03/15/2012 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
| K113797 |
03/02/2012 |
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
| K113790 |
03/06/2012 |
DISPOSABLE VINYL EXAM GLOVE, POWDERED |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABTEH DENG |
| K113860 |
03/12/2012 |
VISUAL-ICE CRYOABLATION SYSTEM |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K120778 |
03/27/2012 |
BRIVO MR355 |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
RUOQIAN LIU |
| K120221 |
03/30/2012 |
GE ECHOPAC |
GE HEALTHCARE |
BRYAN BEHN |
| K113265 |
03/22/2012 |
GENII GI 4000 ELECTROSUGICAL GENERATOR |
GENII, INC. |
JULIE POWELL |
| K120101 |
03/27/2012 |
INDEPENDENCE SPACER |
GLOBUS MEDICAL INC. |
MERIAM YOUSSEF |
| K110745 |
03/02/2012 |
HELICOBACTER PYLORI ELISA IGG TEST KIT |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
| K113624 |
03/12/2012 |
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K113238 |
03/01/2012 |
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K113239 |
03/16/2012 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K102900 |
03/21/2012 |
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM |
HEI, INC. |
GREGORY MATHISON |
| K113575 |
03/07/2012 |
HILLA DIGITAL TRANSFERS |
HILLA TECHNOLOGIES, INC. |
CAROLYN M PRIMUS |
| K112392 |
03/19/2012 |
HIVOX BIOTEK INC. |
HIVOX BIOTEK, INC. |
JEN KE-MIN |
| K113356 |
03/06/2012 |
HOLOGIC VISCERAL FAT SOFTWARE |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K120593 |
03/23/2012 |
MYOSURE CONTROL UNIT |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K120358 |
03/06/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HONGXIN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K110901 |
03/05/2012 |
SYMBIQ INFUSION AND ADMINSTRATION SET |
HOSPIRA, INC. |
Ray Silkaitis |
| K111426 |
03/01/2012 |
EUCLID (TM) TIER 1-GW ACCESS SYSTEM |
HOUSTON MEDICAL ROBOTICS |
DARLA J ELKIN |
| K120578 |
03/29/2012 |
ACCOLADE II HIP STEM |
HOWMEDICA OSTEONICS |
VALERIE GIAMBANCO |
| K120602 |
03/23/2012 |
APACERAM BONE GRAFT SUBSTITUTE |
HOYA CORPORATION |
PATSY J TRISLER |
| K112422 |
03/28/2012 |
CRAG LATERAL FLOW ASSAY (LFA) |
IMMUNO-MYCOLOGICS, INC. |
SEAN K BAUMAN |
| K112702 |
03/29/2012 |
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS |
IMPERIAL SURGICAL LTD. |
KATHRYN RONALDS |
| K113748 |
03/23/2012 |
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) |
IMRIS, INC. |
Sanjay Shah |
| K120373 |
03/16/2012 |
INSORB ABSORBALBE STAPLE |
INCISIVE SURGICAL, INC. |
DAVID HERRIDGE |
| K120005 |
03/29/2012 |
ACDS |
ISOPURE CORP. |
KEVIN GILLESPIE |
| K113357 |
03/21/2012 |
POSEY BED |
J. T. POSEY CO. |
BONNIE BISHOP |
| K112950 |
03/28/2012 |
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR |
JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD |
JEN KE-MIN |
| K112948 |
03/28/2012 |
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR |
JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD |
JEN KE-MIN |
| K120526 |
03/08/2012 |
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
NED DEVINE |
| K112351 |
03/30/2012 |
ULTRA BEAUTY |
JOHARI DIGITAL HEALTHCARE, LTD. |
POOJA JOHARI |
| K120031 |
03/16/2012 |
CHESAPEAKE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K113247 |
03/27/2012 |
ANESTHESIA INJECTION TOOL SET |
KI WORKS CO., LTD. |
EILEEN YANG |
| K113423 |
03/09/2012 |
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE |
KIMBERLY-CLARK CORP. |
LESTER F PADILLA |
| K112064 |
03/23/2012 |
RESORB X-G |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K120538 |
03/23/2012 |
PALLS M SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
APRIL LEE |
| K120379 |
03/30/2012 |
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S |
KURARAY MEDICAL INC. |
MICHIO TAKIGAWA |
| K120378 |
03/30/2012 |
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S |
KURARAY MEDICAL INC. |
MICHIO TAKIGAWA |
| K120270 |
03/26/2012 |
VENUS SPINAL FIXATION SYSTEM |
L&K BIOMED CO., LTD |
HEE KYEONG JOO |
| K120399 |
03/09/2012 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
MICHAEL FUNK |
| K102189 |
03/14/2012 |
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM |
LATEXX MANUFACTURING SDN.BHD. |
NEIL BURRIS |
| K113264 |
03/02/2012 |
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) |
LD TECHNOLOGY LLC |
ABBERT MAAREK |
| K113157 |
03/13/2012 |
AILERON INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K110761 |
03/09/2012 |
MICT TSH |
MAGNABIOSCIENCES, LLC |
JAMES L WYATT |
| K112507 |
03/01/2012 |
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
DIONNE SANDERS |
| K112078 |
03/19/2012 |
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) |
MARUCHI |
Priscilla Chung |
| K111558 |
03/27/2012 |
SURGICASE GUIDE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K113232 |
03/01/2012 |
MAXMIXING BLOCK |
MAXTEC, INC. |
TAMMY LAVERY |
| K113686 |
03/06/2012 |
KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED |
MAYER LABORATORIES, INC. |
DAVID P MAYER |
| K113515 |
03/16/2012 |
HORIZON CARDIOLOGY ECG MANAGEMENT |
MCKESSON ISRAEL LTD. |
TOMER LEVY |
| K111058 |
03/30/2012 |
URETRON MODEL URT |
MED-SONICS CORP |
WILLIAM A STOLL |
| K113304 |
03/23/2012 |
BLADDER SCANNER |
MEDA CO. LTD. |
KAI CHEN |
| K113487 |
03/09/2012 |
HEMO-CATH 10F, HEMO-CATH 12.5F |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K112648 |
03/13/2012 |
ASFORA BULLET CAGE |
MEDICAL DESIGNS, LLC |
KRISTI VONDRA |
| K112769 |
03/01/2012 |
CURAD COMPRESSION HOSIERY |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
| K120088 |
03/29/2012 |
MCOMPASS ANORECTAL MANOMETRY SYSTEM |
MEDSPIRA, LLC |
JIM QUACKENBUSH |
| K120206 |
03/29/2012 |
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS |
MEDTRONIC MINIMED |
TAMAR JAGHASBANIAN |
| K120484 |
03/27/2012 |
VISIA ONCOLOGY |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
| K113455 |
03/02/2012 |
SOLITAIRE FR REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
Laura Heaton |
| K120630 |
03/28/2012 |
AZUR DETACHABLE 18 |
MICRO VENTION, INC. |
CYNTHIA VALENZUELA |
| K120608 |
03/15/2012 |
ENDOSCOPIC APPLICATOR |
MICROMEDICS, INC. |
LISE W DURAN |
| K120563 |
03/30/2012 |
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT |
MICROPHAGE, INC. |
DREW SMITH |
| K113655 |
03/05/2012 |
TI-MAX X TURBINE |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K113712 |
03/15/2012 |
IM-11 PNEUMATIC MICROINJECTOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K113474 |
03/16/2012 |
1.5T GEM FLEX COIL |
NEOCOIL, LLC |
STEVEN NICHOLS |
| K113733 |
03/23/2012 |
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
KEVIN A THOMAS |
| K120380 |
03/09/2012 |
SATURN 8000 |
NEW MEDICAL CO., LTD. |
JUN-HSIUNG LIN |
| K103623 |
03/20/2012 |
NEWDEAL INTERPHALANGEAL IMPLANT |
NEWDEAL SAS |
MARILYSE LATOUR |
| K113117 |
03/22/2012 |
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX |
NIHON KOHDEN AMERICA, INC. |
STEVE GEERDES |
| K120485 |
03/16/2012 |
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P |
NIHON KOHDEN AMERICA, INC. |
STEVE GEERDES |
| K112969 |
03/14/2012 |
AIR-BAG SYSTEM |
NIIGATA MECHATRONICS CO., LTD. |
TOSHIYA NIMONJI |
| K113429 |
03/12/2012 |
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K113763 |
03/16/2012 |
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
MARIA HATEGAN |
| K112638 |
03/09/2012 |
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
| K112561 |
03/13/2012 |
NUVASIVE COROENT NO-PROFILE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K112718 |
03/16/2012 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K113788 |
03/16/2012 |
DEFLEX ACRILATO |
NUXEN S.R.L. |
HERNAN ILARI |
| K112133 |
03/01/2012 |
OASYS SURGICAL LIGHT CONTROLLER |
OASYS HEALTHCARE |
TANYA M O'BRIEN |
| K110337 |
03/16/2012 |
UNIVERSAL MAXILLARY MOLAR |
OCO BIOMEDICAL |
JACK BLOOM |
| K111756 |
03/20/2012 |
V1 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
STACY ABBATIELLO KLUESNER |
| K110690 |
03/28/2012 |
ONE PERSONAL LUBRICANT (SILICONE) |
ONE |
SHARON PIETILA |
| K120115 |
03/14/2012 |
ORTHOSIZE |
ORTHOSIZE LLC |
YARMELA PAVLOVIC |
| K120738 |
03/29/2012 |
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K113594 |
03/02/2012 |
C-THV SYSTEM |
PAIEON, INC. |
EREZ BEN-ZVI |
| K113188 |
03/01/2012 |
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
| K113037 |
03/01/2012 |
PAIN-AID |
PDI WORKS, LLC. |
THU-HA DUNCAN |
| K113082 |
03/08/2012 |
SONOVISION |
PERIDOT TECHNOLOGIES NY INC |
OMAR BARLAS |
| K113354 |
03/13/2012 |
VETA PERITONEAL DIALYSIS CATHETER |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K120525 |
03/09/2012 |
QLAB QUANTIFICATION SOFTWARE |
PHILIPS HEALTHCARE GROUP |
PENNY GRECO |
| K113657 |
03/22/2012 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MANFRED STEVER |
| K113441 |
03/22/2012 |
PHYSIOLOGICAL MONITOR, PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JENS-PETER SEHER |
| K120109 |
03/07/2012 |
SUPER SEAL TOOTH DESENSITIZER |
PHOENIX DENTAL, INC. |
JEFFREY S COX |
| K120355 |
03/07/2012 |
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K113807 |
03/07/2012 |
DEXERYL CREAM |
PIERRE FABRE MEDICAL DEVICES |
DIANE MANDELL HORWITZ |
| K112757 |
03/12/2012 |
PIONEER POSTERIOR CERVICO THORACIC SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. |
EMILY M DOWNS |
| K113122 |
03/20/2012 |
PIPELINE CR PRIMARY KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K112802 |
03/09/2012 |
PIPELINE TOTAL HIP SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K112573 |
03/22/2012 |
EZSLEEP SLEEP QUALITY RECORDER |
PLATINUM TEAM CO., LTD |
JAMES HO |
| K113818 |
03/21/2012 |
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K120213 |
03/30/2012 |
ETCH-RITE SUPREME |
PULPDENT CORPORATION |
KENNETH J BERK |
| K113711 |
03/05/2012 |
LIME-LITE II |
PULPDENT CORPORATION |
KENNETH J BERK |
| K113617 |
03/02/2012 |
SPEE-DEE PATCH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K113249 |
03/01/2012 |
TRANSPORT CULTURE MEDIUM DEVICE |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K120627 |
03/29/2012 |
TOSHIBA 1.5T QD HEAD COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K113777 |
03/15/2012 |
QUIDEL MOLECULAR INFLUENZA A+B |
QUIDEL CORP. |
Ronald H Lollar |
| K120197 |
03/19/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K113540 |
03/12/2012 |
RELIANCE LUMBAR IBF SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K113815 |
03/27/2012 |
RESSCAN |
RESMED LTD. |
DAVID D'CRUZ |
| K113288 |
03/29/2012 |
VPAP ST-A |
RESMED LTD. |
DAVID D'CRUZ |
| K120145 |
03/30/2012 |
SIMPLE T NASAL MASK |
RESPIRONICS INC. |
MICHELLE BRINKER |
| K112798 |
03/29/2012 |
LOCKING COMPRESSION PLATE SYSTEM |
SHANGHAI MICROPORT ORTHOPEDICS CO., LTD |
JASON MA |
| K113865 |
03/21/2012 |
PULTOL |
SHARP CORPORATION |
DIANE RUTHERFORD |
| K113233 |
03/29/2012 |
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM |
SHEN WEI (USA), INC. |
ALBERT LI |
| K112377 |
03/23/2012 |
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K112307 |
03/28/2012 |
RESIGLASS PASTE |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K112154 |
03/16/2012 |
FEMTO LDV |
SIE AG,SURGICAL INSTUMENT ENGINEERING |
Kevin Walls |
| K120363 |
03/20/2012 |
SYNGO RT INTERFACE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K111792 |
03/05/2012 |
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN, PHD |
| K113274 |
03/06/2012 |
FOOTPRINT ULTRA PK SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
MELISSA EGAN |
| K113700 |
03/14/2012 |
VIAVALVE SAFETY IV CATHETER |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K112469 |
03/23/2012 |
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM |
SONOWAND AS |
CONSTANCE G BUNDY |
| K112478 |
03/22/2012 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K113051 |
03/22/2012 |
SPACELABS ARKON ANESTHESIA WORKSTATION |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K120616 |
03/29/2012 |
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 |
SPACELABS MEDICAL, INC. |
THOMAS KROENKE |
| K120416 |
03/27/2012 |
INSULATION TESTER |
SPECTRUM SURGICAL SUPPLY CORP. |
DENNIS A KOVIT |
| K113584 |
03/02/2012 |
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER |
ST. JUDE MEDICAL |
BRYAN COWELL |
| K120544 |
03/19/2012 |
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN |
ST. JUDE MEDICAL |
MARLENE PETERSON |
| DEN110002 |
03/30/2012 |
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT |
STERIS Corporation |
ROBERT SULLIVAN |
| K113327 |
03/29/2012 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K120434 |
03/08/2012 |
POWER ADAPTOR INSTRUMENT ACCESSORY |
STRYKER CORP. |
TIFFANI ROGERS |
| K112659 |
03/09/2012 |
SURGICAL RETRACTORS |
SURGICAL INNOVATIONS PLC |
STEPHEN SEED |
| K120070 |
03/21/2012 |
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM |
SYNTHES USA |
ANGELA F LASSANDRO |
| K113297 |
03/02/2012 |
KNOTILUS ANCHOR SYSTEM |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
GEORGE J HATTUB |
| K113422 |
03/05/2012 |
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE |
TERUMO (PHILIPPINES) CORPORATION |
SANDI HARTKA |
| K120074 |
03/14/2012 |
FOUNDATION SPINAL SYSTEM |
THE SKELETAL DESIGN PARTNERSHIP LTD. |
KAREN E WARDEN, PHD |
| K113097 |
03/02/2012 |
LASER HELMET |
THERADOME INC. |
LARRY PETERSEN |
| K120254 |
03/06/2012 |
THERASAGE HEATING PAD |
THERASAGE CORPORATION |
ROBERT BESNER |
| K110520 |
03/23/2012 |
BIOLIS 12I |
TOKYO BOEKI MEDISYS INC. |
James M Clinton |
| K112144 |
03/13/2012 |
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS |
TORNIER |
SEVERINE BONNETON |
| K113413 |
03/09/2012 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K120677 |
03/15/2012 |
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K111544 |
03/02/2012 |
GLIDER PTCA BALLOON CATHETER |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K112012 |
03/21/2012 |
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES |
UG HEALTHCARE (USA), INC. |
KEN STANTON |
| K112005 |
03/21/2012 |
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
UG HEALTHCARE (USA), INC. |
KEN STANTON |
| K120123 |
03/28/2012 |
AQUASHIELD CO2 SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K112887 |
03/21/2012 |
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR |
UPSTREAM PERIPHERAL TECHNOLOGIES |
JANICE M HOGAN |
| K113766 |
03/16/2012 |
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K112100 |
03/20/2012 |
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K113672 |
03/27/2012 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K111869 |
03/05/2012 |
VIRTUOSO SYSTEM FOR IHC PR (IE2) |
VENTANA MEDICAL SYSTEMS, INC. |
TROY QUANDER |
| K111670 |
03/02/2012 |
VENUS FREEZE (MP)2 SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K112834 |
03/28/2012 |
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES |
VERICHEM LABORATORIES, INC. |
ANTHONY JAMES DIMONTE |
| K113872 |
03/08/2012 |
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K112902 |
03/14/2012 |
ENFLOW IV FLUID WARMER |
VITAL SIGNS, INC. |
STACIE GEFFNER-ATIYA |
| K120318 |
03/06/2012 |
VIVI ERGON-X HF |
VIVI S.R.L. |
GUIDO BONAPACE |
| K120480 |
03/16/2012 |
GORE(R) EMBOLIC FILTER |
W.L. GORE & ASSOCIATES |
MICHELLE ANN WELLS |
| K120743 |
03/23/2012 |
SPECULUM, VAGINAL, NONMETAL |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K112119 |
03/30/2012 |
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH |
WILLIAM COOK EUROPE APS |
Jennifer Brown |
| K120799 |
03/30/2012 |
ARISURE NEUTRAL VALVE |
YUKON MEDICAL, LLC |
CARL DUPPER |
| K120576 |
03/28/2012 |
ZAVATION IBF SYSTEM |
ZAVATION LLC |
JOHN WALKER |
| K103704 |
03/23/2012 |
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP |
ZEPHYR SLEEP TECHNOLOGIES INC |
SABINA BRUCHLMANN |
| K110536 |
03/19/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO TENGYUE PLASTIC PRODUCTS CO., LTD. |
FRANK LIU |
| K113369 |
03/27/2012 |
ZIMMER PERSONA KNEE SYSTEM |
ZIMMER INC. |
KELLI ANDERSON |
| K112998 |
03/15/2012 |
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 |
ZOLL CIRCULATION |
SAM NANAVATI |
| K112432 |
03/21/2012 |
ZOLL X SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHARLES W KOLIFRATH |
