| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K090060 |
06/02/2009 |
NEXLINK OCT SYSTEM, MODEL 7000 SERIES |
ABBOTT SPINE, INC. |
DAVID PADGETT |
| K090660 |
06/12/2009 |
AIRWAY BALLOON CATHETER INFLATION DEVICE |
ACCLARENT, INC. |
KERI YEN |
| K083144 |
06/16/2009 |
ACUMED CLAVICLE SCREW SYSTEM |
ACUMED LLC |
ALYSSA THOMAS |
| K090837 |
06/17/2009 |
STRATAPULSE TS AND STRATAPULSE |
ADVANCED MEDICAL PHOTONICS |
SCOTT PORTER |
| K090907 |
06/02/2009 |
PENTA LEAD KITS, MODELS: 3227-3234 |
ADVANCED NEUROMODULATION SYSTEMS |
AMY CLENDENING |
| K082068 |
06/25/2009 |
E. COLI PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K083772 |
06/04/2009 |
COLUMBUS REVISION KNEE SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K090375 |
06/23/2009 |
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K090347 |
06/18/2009 |
CAMLOG ABUTMENTS PS |
ALTATEC GMBH |
LINDA SCHULZ |
| K090934 |
06/02/2009 |
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
SARAH MEYER |
| K090772 |
06/04/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K090770 |
06/04/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K090771 |
06/04/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K090769 |
06/04/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K090768 |
06/04/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083687 |
06/11/2009 |
BAIXIN INTRAVASCULAR ADMINISTRATION SET |
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. |
BIAN WEI QIANG |
| K091432 |
06/12/2009 |
XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K090583 |
06/26/2009 |
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 |
APOLLO ENDOSURGERY, INC. |
GREG MATHISON |
| K090306 |
06/18/2009 |
ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K091038 |
06/19/2009 |
AS 1000 ULTRASOUND WOUND THERAPY SYSTEM |
AROBELLA MEDICAL, LLC |
ELIAZ BABAEV |
| K083435 |
06/26/2009 |
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID |
ARTHREX, INC. |
SALLY F OUST |
| K090393 |
06/23/2009 |
ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K091503 |
06/17/2009 |
MAGNUM MP FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K090615 |
06/03/2009 |
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K082910 |
06/17/2009 |
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES |
ASO LLC |
JONATHAN WARD |
| K090455 |
06/05/2009 |
PROVOX VEGA, MODEL 8130-8135 |
ATOS MEDICAL AB |
FERENC DAHNER |
| K090909 |
06/04/2009 |
C-QUR V -PATCH MESH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K083723 |
06/05/2009 |
A6 LUER ACCESS DEVICE |
B. BRAUN MEDICAL, INC. |
BONNIE J KINCAID, RAC |
| K090884 |
06/29/2009 |
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. |
B. BRAUN MEDICAL, INC. |
ANGELA J CARAVELLA |
| K090680 |
06/10/2009 |
HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE |
BECTON DICKINSON & CO. |
JOHN ROBERTS |
| K090824 |
06/02/2009 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SABA MODJARRAD |
| K090971 |
06/05/2009 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
KATHRYN BABKA CARR |
| K091317 |
06/25/2009 |
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K090737 |
06/03/2009 |
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI |
BIO-RAD LABORATORIES, INC. |
JOLENE BARTILSON |
| K090164 |
06/26/2009 |
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K080469 |
06/22/2009 |
VIDAS CA 15-3 ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K091126 |
06/18/2009 |
VITEK 2 GRAM POSITIVE DAPTOMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K091340 |
06/09/2009 |
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
| K091510 |
06/26/2009 |
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 |
Boston Scientific Corporation |
Marybeth Gamber |
| K091035 |
06/24/2009 |
FULL BREATH SLEEP APPLIANCE LOWER (FBSL) |
BRYAN KEROPIAN DDS |
BRYAN KEROPIAN |
| K091370 |
06/05/2009 |
RADIA STEERABLE DIAGNOSTIC CATHETER |
C.R. BARD, INC. |
JULIA BRODERICK |
| K091545 |
06/15/2009 |
DIGITAL RADIOGRAPHY CXDI-60C |
CANON INC. |
SHEILA DRISCOLL |
| K091636 |
06/22/2009 |
OSTENE CT, AOC CT, OSTEOTENE, CERETENE |
CEREMED INC. |
TADEUSZ WELLISZ |
| K091032 |
06/22/2009 |
CERNER PROVISION WORKSTATION (VERSION 2.5) |
CERNER CORP. |
SHELLEY S LOOBY |
| K090632 |
06/01/2009 |
COMPEX REHAB |
CHATTANOOGA GROUP |
NORA C.R. YORK |
| K083640 |
06/29/2009 |
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D |
CHOONGWAE MEDICAL CORP. |
CHARLIE MACK |
| K083716 |
06/08/2009 |
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
| K090970 |
06/12/2009 |
FLOCONTROL , MODEL 1028 |
COAXIA, INC. |
SHARON D KVISTAD |
| K090720 |
06/17/2009 |
COCHLEAR BAHA BP100 |
COCHLEAR BONE ANCHORED SYSTEMS AB |
SEAN BUNDY |
| K091346 |
06/02/2009 |
CODMAN HAKIM MICRO II VALVE |
Codman & Shurtleff, Inc. |
SHARON MCDERMOTT |
| K083895 |
06/23/2009 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
Codman & Shurtleff, Inc. |
EMILY E VALERIO |
| K090894 |
06/25/2009 |
COLLAWOUND WOUND DRESSING |
COLLAMATRIX CO., INC. |
DENNIS J.N. SEAH |
| K091315 |
06/05/2009 |
COVIDIEN EXTENDED TIP APPLICATOR |
CONFLUENT SURGICAL,INC |
SEAN REYNOLDS |
| K090560 |
06/29/2009 |
CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS |
CONMED LINVATEC |
REBECCA ROBERTS |
| K090671 |
06/11/2009 |
PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K091527 |
06/12/2009 |
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
NATHAN SIMON |
| K091325 |
06/29/2009 |
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS |
COOPER SURGICAL |
THOMAS G WILLIAMS |
| K090696 |
06/19/2009 |
NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM |
CORVENTIS, INC. |
MADHURI BHAT |
| K090284 |
06/05/2009 |
RES-Q INFANT WEDGE AND SLING |
CR ENTERPRISES, LLC. |
CRAIG A TROOP |
| K090566 |
06/01/2009 |
PATHWAY AVID |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
| K091449 |
06/18/2009 |
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
DOLLY MISTRY |
| K081259 |
06/15/2009 |
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
DEFIBTECH, LLC |
Ed Horton |
| K091096 |
06/18/2009 |
NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 |
DENTAL SOLUTIONS, INC. |
ANDREW PAENG |
| K091660 |
06/12/2009 |
CUSTOM COMFORT NIGHTGUARD VERSION 2 |
DENTEK ORAL CARE, INC. |
HOWARD M HOLSTEIN |
| K082843 |
06/19/2009 |
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM |
DENTIS CO. LTD. |
JUNG BAE BANG |
| K090998 |
06/12/2009 |
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K090877 |
06/26/2009 |
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K090648 |
06/10/2009 |
VIPER 2 SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K090431 |
06/22/2009 |
DEXIS SOFTWARE |
DEXIS LLC |
CLAUDIA ORTIZ |
| K090307 |
06/18/2009 |
DDI ULTRASONIC NEBULIZER SYSTEM |
DIAGNOSTIC DEVICES, INC. |
E.J SMITH |
| K091680 |
06/19/2009 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K090367 |
06/03/2009 |
SE-601 SERIES ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K083008 |
06/10/2009 |
COOLSKIN |
ELBIO CO., LTD |
JAY MANSOUR |
| K083292 |
06/10/2009 |
HABIB ENDOHPB |
EMCISION, LTD. |
NAGY HABIB |
| K090415 |
06/01/2009 |
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM |
EMINENT SPINE |
DAVE FREEHILL |
| K090922 |
06/05/2009 |
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR |
EMPI |
SANDRA WALROD |
| K090109 |
06/24/2009 |
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD |
EPOCAL, INC. |
ROY LAYER |
| K091322 |
06/01/2009 |
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G |
ETHICON ENDO-SURGERY, INC. |
ASIFA VONHOF |
| K083669 |
06/08/2009 |
OBI |
EUROTEKNIKA |
EMMANUEL MONTINI |
| K091362 |
06/29/2009 |
CERAMIC PEDATRIC PREFORMED CROWN |
EZ-PEDO INC |
JEFFREY FISHER |
| K083690 |
06/23/2009 |
FEMVUE(TM) CATHETER SYSTEM |
FEMASYS INC. |
MARC FINCH |
| K091591 |
06/17/2009 |
FLEXICARE MEDICAL ENDOTRACHEAL TUBES |
FLEXICARE MEDICAL LTD. |
DAVID MOYNHAM |
| K090621 |
06/19/2009 |
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 |
FLOWCARDIA, INC. |
Dustin Michaels |
| K090933 |
06/05/2009 |
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS |
FORESTADENT BERNHARD FORSTER GMBH |
MICHAEL FIEB |
| K090126 |
06/29/2009 |
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, |
FOTONA D.D. |
STOJAN TROST |
| K090821 |
06/10/2009 |
CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L |
FRANKENMAN INTERNATIONAL LIMITED |
JEAN ASQUITH |
| K083158 |
06/05/2009 |
EXALIS, SOFTWARE VERSION 1.15 |
GAMBRO, INC. |
KAE MILLER |
| K091106 |
06/17/2009 |
EQUIA |
GC AMERICA, INC. |
MARK HEISS |
| K090747 |
06/10/2009 |
MI FLOW (GCUC-450) |
GC AMERICA, INC. |
MARK HEISS |
| K091658 |
06/29/2009 |
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 |
GE HEALTHCARE |
ALAN TOTAH |
| K091673 |
06/24/2009 |
GE LIGHTSPEED ACT FP16 |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K090283 |
06/05/2009 |
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 |
GENCHEM, INC. |
JAMES M HENNEMAN |
| K090565 |
06/30/2009 |
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K091151 |
06/01/2009 |
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN |
GX CORPORATION SDN BHD |
FOO K PU |
| K090412 |
06/01/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K090468 |
06/15/2009 |
HAMILTON-C2 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K090910 |
06/30/2009 |
HANSO ACUPUNCTURE NEEDLE |
HANSOL MEDICAL CO. |
PETER CHUN |
| K091103 |
06/15/2009 |
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K091368 |
06/04/2009 |
R2 DIGITALNOW HD(DIGITALNOW HD) |
HOLOGIC, INC. |
MICHAELA MAHL |
| K090132 |
06/09/2009 |
MAXMORESPINE SPINAL SYSTEM |
HOOGLAND SPINE PRODUCTS GMBH |
BORIS MIKLITZ |
| K091161 |
06/16/2009 |
REJUVENATE MONOLITHIC SIZE 4 HIP STEM |
HOWMEDICA OSTEONICS CORP |
ESTELA CELI |
| K083899 |
06/01/2009 |
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K082883 |
06/16/2009 |
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082880 |
06/16/2009 |
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082879 |
06/16/2009 |
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
I-SEE VISION TECHNOLOGY INC |
JENNIFER REICH |
| K082450 |
06/30/2009 |
IDR |
ICRCO INC. |
THOMAS CHANEY |
| K082196 |
06/16/2009 |
STATIC VESSEL ANALYZER |
IMEDOS GMBH |
HANS STROMEYER |
| K090958 |
06/18/2009 |
INOMAX DS (DELIVERY SYSTEM) |
INO THERAPEUTICS LLC |
DAVID TRUEBLOOD |
| K090611 |
06/04/2009 |
REVOLUTION FULL CORE BIOPSY |
INRAD |
MELISSA LALOMIA |
| K090209 |
06/02/2009 |
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K083520 |
06/23/2009 |
INTELEPACS, MODEL VERSION 3.X.X |
INTELERAD MEDICAL SYSTEMS INCORPORATED |
ANIBAL JODORCOVSKY |
| K091323 |
06/04/2009 |
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) |
INTERMEDIC ARFRAN, S.A. |
ANNE WORDEN |
| K090767 |
06/11/2009 |
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER |
INTERVENTIONAL SPINE, INC. |
CAROL EMERSON |
| K091001 |
06/29/2009 |
MYRIAN 1.4 |
INTRASENSE |
FREDERIC BANEGAS |
| K091020 |
06/12/2009 |
BLUEPHASE 20I |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K090704 |
06/17/2009 |
MULTILINK IMPLANT |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K091019 |
06/04/2009 |
SPEEDCEM |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K090422 |
06/17/2009 |
LUCAS 2 |
JOLIFE AB |
HOWARD M HOLSTEIN |
| K083753 |
06/19/2009 |
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K083256 |
06/26/2009 |
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K091253 |
06/04/2009 |
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS |
K2M, INC. |
RICHARD W WOODS |
| K090273 |
06/05/2009 |
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 |
KAI SENSORS, INC |
AMY DROITCOUR |
| K090786 |
06/18/2009 |
KENS INTERNAL FIXATION SYSTEM |
KENS FINEMEDTECH SDN. BHD |
LEOW K HOOI |
| K090397 |
06/05/2009 |
XPI ANGLED ABUTMENTS |
KEYSTONE DENTAL, INC. |
CAROLYN BITETTI |
| K082505 |
06/12/2009 |
KLS MARTIN ELECTROSURGICAL INSTRUMENTS |
KL MARTIN L.P. |
TOM FAUCETT |
| K083195 |
06/05/2009 |
MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K090443 |
06/05/2009 |
PLANET 55, MODEL 100 |
LARSEN & TOUBRO LIMITED |
YOLANDA SMITH |
| K090172 |
06/05/2009 |
STAR 55 MODEL 100 |
LARSEN & TOUBRO LIMITED |
S.B. BHOSALE |
| K090507 |
06/25/2009 |
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K083580 |
06/22/2009 |
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 |
LED INTELLECTUAL PROPERTIES, LLC |
ROBERT T WAGNER |
| K082367 |
06/12/2009 |
INFANT SLEEP BEANIE |
LIFE INNOVATIONS LLC |
JANE SCOTT |
| K090865 |
06/26/2009 |
LIFE SPINE FACET SCREW SPINAL SYSTEM |
LIFE SPINE |
MURALI AUDIPUDY |
| K090835 |
06/22/2009 |
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR |
LINVATEC CORP. |
JOY LOVETT |
| K091549 |
06/23/2009 |
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM |
LINVATEC CORP. |
JOHN CUSACK |
| K091667 |
06/25/2009 |
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K091225 |
06/25/2009 |
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K083644 |
06/19/2009 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K090763 |
06/17/2009 |
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM |
MAKO SURGICAL CORPORATION |
WILLIAM F TAPIA |
| K090511 |
06/12/2009 |
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 |
MAQUET CARDIOPULMONARY AG |
FRANK MOEHRKE |
| K083275 |
06/09/2009 |
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 |
MAX ENDOSCOPY INC. |
MICHAEL WOLF |
| K091518 |
06/18/2009 |
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM |
MCUBE TECHNOLOGY CO., LTD. |
CHARLIE MACK |
| K091400 |
06/11/2009 |
MODIFICATION TO AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
| K091069 |
06/01/2009 |
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K083862 |
06/05/2009 |
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM |
MEDAPPS, INC. |
KENT DICKS |
| K091466 |
06/17/2009 |
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 |
MEDCOMP |
Susan Pileggi |
| K090721 |
06/16/2009 |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 |
Medtronic |
PETER LIU |
| K082166 |
06/02/2009 |
MASTERGRAFT STRIP |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K083016 |
06/16/2009 |
ACTHYDERM |
MICROLAB AMERICAS INC |
E J SMITH |
| K091589 |
06/10/2009 |
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K091641 |
06/30/2009 |
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) |
MICROVENTION, INC. |
Naomi Gong |
| K090891 |
06/22/2009 |
MICROPLEX COIL SYSTEM-COSMOS |
MICROVENTION, INC. |
Naomi Gong |
| K091504 |
06/19/2009 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 |
MICRUS ENDOVASCULAR CORPORATION |
TED RUPPEL |
| K090668 |
06/23/2009 |
VISION TOOLS |
MILLENSYS |
CHRISTINE NICHOLS |
| K083685 |
06/25/2009 |
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 |
MRI MANUFACTURING AND RESEARCH, INC. |
SUZANNE DEW |
| K090426 |
06/12/2009 |
VAKU-8 BLOOD COLLECTION NEEDLES |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
| K080941 |
06/18/2009 |
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM |
N.I. MEDICAL, LTD. |
JAMES COLLIE |
| K090034 |
06/02/2009 |
EASY ON-PC SPIROMETER |
NDD MEDIZITECHNIK AG |
JERRY MASIELLO |
| K090885 |
06/29/2009 |
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER |
NEPHROS, INC. |
VIKKI M O'CONNOR |
| K091609 |
06/30/2009 |
NEWDEAL COMPRESSION PLATE |
NEWDEAL SAS |
JUDITH E O'GRADY |
| K083352 |
06/12/2009 |
VEINWAVE, TC3000 |
NEWLANDS CLINICAL TRIALS LTD |
WILLIAM GREENROSE |
| K090984 |
06/30/2009 |
INERTIA PEDICLE SCREW SYSTEM |
NEXXT SPINE LLC |
KAREN WARDEN |
| K090630 |
06/02/2009 |
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K090807 |
06/30/2009 |
REGIONAL OXIMETER SYSTEM, MODEL 7600 |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K091546 |
06/24/2009 |
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K090546 |
06/08/2009 |
MODIFICATION TO NORDICICE SOFTWARE |
NORDICIMAGINGLAB AS |
CHANDANA G BHANDARI |
| K083583 |
06/30/2009 |
XPRESSE INJECTION SYSTEM |
NORDSON EFD |
JEFF PEMBROKE |
| K080365 |
06/29/2009 |
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR |
NOUVAG AG |
ERICH FORSTER |
| K091484 |
06/15/2009 |
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GALSSER |
| K091598 |
06/29/2009 |
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS |
NUCLETRON CORP. |
ELAINA COLBY |
| K090706 |
06/15/2009 |
ONCENTRA SIMULATION 2.3 |
NUCLETRON CORPORATION |
ELAINE COLBY |
| K090298 |
06/08/2009 |
NUVASIVE NEURO VISION SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K090206 |
06/02/2009 |
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER |
OCULUS INNOVATIVE SCIENCES, INC. |
ANTOINETTE DOUGLAS |
| K090938 |
06/04/2009 |
FLOW CONTROLLER |
ODYSSEY MEDICAL, INC. |
TERRY R GREEN |
| K090980 |
06/29/2009 |
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L |
OLYMPUS WINTER & IBE GMBH |
STACY A KUESNER |
| K091602 |
06/18/2009 |
MUCHECK V8 |
ONCOLOGY DATA SYSTEMS, INC. |
VINCE RUMINER |
| K090289 |
06/15/2009 |
CLAVICLE PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K080108 |
06/05/2009 |
CORTOSS BONE AUGMENTATION MATERIAL |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
| K090114 |
06/04/2009 |
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S |
Oscor Inc. |
MILA DOSKOCIL |
| K083057 |
06/02/2009 |
I-MAX TOUCH |
OWANDY |
CLAUDE D BERTHOIN |
| K090525 |
06/01/2009 |
LOI SYSTEM |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K090099 |
06/19/2009 |
DSS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K090923 |
06/30/2009 |
PARCUS GRAFT FIXATION SYSTEM |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K083616 |
06/12/2009 |
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS |
PATHOLASE, INC |
ANNE WORDEN |
| K091509 |
06/19/2009 |
JETSTREAM G2 NXT SYSTEM, MODEL PV20300 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K091478 |
06/18/2009 |
TREVAIR CHAIR |
PATMONT MOTOR WERKS, INC. |
STEVEN J PATMONT |
| K083415 |
06/05/2009 |
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K090167 |
06/18/2009 |
PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, |
PHILIPS ELECTRONICS UK LIMITED |
MIRIAM SHARIF- MURRAY |
| K090462 |
06/23/2009 |
BRILLIANCE DUAL ENERGY OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL A CHILBERT |
| K091395 |
06/05/2009 |
MP5 INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K083449 |
06/12/2009 |
E-MATRIX GRAFT BONE EXTENDER |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K090430 |
06/02/2009 |
BACKSTOP AND BACKSTOP INJECTOR |
PLUROMED, INC. |
JAMES WILKIE |
| K091593 |
06/22/2009 |
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS |
POSSIS MEDICAL, INC. |
Doug Atkins |
| K091026 |
06/24/2009 |
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K090848 |
06/17/2009 |
PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM |
PREMIER BRANDS OF AMERICA, INC. |
MACK CAUTHEN |
| K091245 |
06/17/2009 |
COSTORSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K081720 |
06/16/2009 |
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS |
PRIME HERBS CORPORATION |
GENEVIEVE HSIA |
| K083883 |
06/25/2009 |
CHARTIS CATHETER |
PULMONX, INC. |
Roberta Hines |
| K083199 |
06/25/2009 |
CHARTIS CONSOLE |
PULMONX, INC. |
SUZON LOMMEL |
| K090962 |
06/19/2009 |
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K091581 |
06/16/2009 |
SUPRA 577.Y LASER |
QUANTEL MEDICAL |
PATRICK QUERO |
| K091260 |
06/08/2009 |
SERAQUEST EBV EA-D IGG TEST |
QUEST INTL., INC. |
DAVID J KIEFER |
| K090484 |
06/26/2009 |
ALICE PDX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K081410 |
06/04/2009 |
OPTION VENA CAVA FILTER |
REX MEDICAL |
LEO BASTA |
| K091055 |
06/23/2009 |
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K091056 |
06/23/2009 |
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K090776 |
06/02/2009 |
MEGAPULSE LASER SYSTEM AND FIBERS |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RON HASELHORST |
| K090939 |
06/18/2009 |
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 |
Roche Diagnostics |
MICHELLE L NEFF |
| K082340 |
06/19/2009 |
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS |
ROCHE DIAGNOSTICS CORP. |
KATHIE J GOODWIN |
| K090951 |
06/05/2009 |
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG |
RS MEDICAL |
TIMOTHY JOHNSON |
| K083756 |
06/26/2009 |
GUARDIAN 150 ELECTRODE |
SELECTIVE MED COMPONENTS, INC. |
JAY MANSOUR |
| K083601 |
06/22/2009 |
LAMBDA LIGHT CHAINS |
SENTINEL CH. SpA |
YANGTSE PORTELLES |
| K090012 |
06/11/2009 |
DISPOSABLE INFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
Diana Hong |
| K090929 |
06/12/2009 |
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
Diana Hong |
| K083010 |
06/10/2009 |
SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
THOMAS KROENKE |
| K090268 |
06/30/2009 |
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION |
SHIMADZU CORP. |
DON KARLE |
| K091427 |
06/23/2009 |
VINYL POWDERED EXAMINATION GLOVE |
SHUN DA (XINGHUA) CO., LTD |
ZHANG YAN |
| K090900 |
06/01/2009 |
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K090745 |
06/18/2009 |
ARTIS ZEE / ZEEGOS WITH SW VC14 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K090656 |
06/03/2009 |
INTERTAN CHS LIMITED COLLAPSE SET SCREW |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K090926 |
06/08/2009 |
SMITH & NEPHEW RAIL SYSTEM |
SMITH & NEPHEW, INC. |
LAURA MEDLIN |
| K090675 |
06/04/2009 |
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES |
SMITH & NEPHEW, INC. |
Jahanvi Agnihotri |
| K083336 |
06/03/2009 |
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL |
SMITHS MEDICAL ASD, INC. |
CHRISTINE LLOYD |
| K083119 |
06/26/2009 |
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 |
SMITHS MEDICAL ASD, INC. |
JOHN TULLETT |
| K091181 |
06/12/2009 |
LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS |
SMITHS MEDICAL MD, INC. |
JAMES CHAPMAN |
| K090580 |
06/26/2009 |
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES |
SOLTA MEDICAL, INC. |
HEATHER MACFALLS |
| K090161 |
06/09/2009 |
EPIPHANY INJECTION SYSTEM |
STAAR SURGICAL CO. |
DIANA SMITH |
| K090093 |
06/10/2009 |
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM |
STANBIO LABORATORY |
KIRK JOHNSON |
| K091136 |
06/29/2009 |
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 |
STERIS Corporation |
ROBERT F SULLIVAN |
| K091291 |
06/24/2009 |
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD |
STRYKER SPINE |
CURTIS TRUESDALE |
| K083917 |
06/02/2009 |
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL |
SUNI MEDICAL IMAGING, INC. |
AL BETTENCOURT |
| K082110 |
06/17/2009 |
DUAL SYRINGE HOLDER |
SURGIN SURGICAL INSTRUMENTATION, INC. |
GRACE HOLLAND |
| K090476 |
06/18/2009 |
SYNTEC ORTHODONTIC MINI SCREW |
SYNTEC SCIENTIFIC CORP. |
SUSAN CHENG |
| K090241 |
06/17/2009 |
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K090404 |
06/23/2009 |
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K090698 |
06/08/2009 |
CAPIOX BUBBLE TRAP WITH X-COATING |
TERUMO CARDIOVASCULAR SYSTEMS |
GARRY A COURTNEY |
| K091490 |
06/11/2009 |
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES |
THD SPA |
GUIDO BONAPACE |
| K091266 |
06/10/2009 |
THEKEN CORAL SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K090115 |
06/30/2009 |
RETINA CAMERA TRC-NW7SF MARK II |
TOPCON CORP. |
TAKAO SUGAWARA |
| K090968 |
06/04/2009 |
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
Cynthia Knapp |
| K090564 |
06/24/2009 |
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 |
TRULY INSTRUMENT LIMITED |
YANG JIAN-HAO |
| K081150 |
06/16/2009 |
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST |
TURKLAB MEDICAL DEVICES INC |
HILDA CIL |
| K090961 |
06/12/2009 |
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) |
TWIN STAR MEDICAL, INC. |
GREGORY W SACHS |
| K090629 |
06/04/2009 |
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K091391 |
06/30/2009 |
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K091132 |
06/17/2009 |
4D INTEGRATED TREATMENT CONSOLE |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K091492 |
06/18/2009 |
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K091209 |
06/23/2009 |
PORTALVISION ADVANCED IMAGING |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K091345 |
06/12/2009 |
GOPHER GOLD CATHETER, MODEL 5620 |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K090977 |
06/18/2009 |
PIGGYBACK WIRE CONVERTER |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K091551 |
06/19/2009 |
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K090987 |
06/19/2009 |
VASCUTEK BRANCHED GELWEAVE |
VASCUTEK LTD. |
KAREN KELSO |
| K090840 |
06/25/2009 |
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. |
VENTLAB CORP. |
JAMES A COCHIE |
| K090180 |
06/17/2009 |
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE |
VERMED, INC. |
MARC FILLION |
| K091505 |
06/10/2009 |
COR12+ |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K090399 |
06/10/2009 |
TRIOS SYSTEM |
VIORA LTD. |
JOSEF LUZON |
| K091498 |
06/05/2009 |
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE |
VITAL IMAGES, INC. |
DARIN BUSCH |
| K090843 |
06/17/2009 |
AMARIS GINGIVA OPAQUER |
VOCO GMBH |
M. TH. PLAUMANN |
| K090548 |
06/30/2009 |
CONTRA-ANGLE HANDPIECE KOMET OS30 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN GEORG SCHARL |
| K090976 |
06/25/2009 |
VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS |
WHIP-MIX CORP. |
ANGELA BLACKWELL |
| K091243 |
06/26/2009 |
ORTHOLOC ANKLE PLATING SYSTEM (APS) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K083305 |
06/18/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K090198 |
06/23/2009 |
JIAJIAN SELF-ADHESIVE ELECTRODE |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K091669 |
06/18/2009 |
OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III |
XIOAO MDT TECHNOLOGY CO LTD |
Diana Hong |
| K090417 |
06/23/2009 |
AXXENT FLEXISHIELD MINI |
XOFT, INC. |
STEVE LIN |
| K090596 |
06/30/2009 |
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K091262 |
06/29/2009 |
MR CARDIAC FUNCTION ANALYSIS |
ZIOSOFT, INC. |
RICHARD BALL |
