| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K083738 |
03/11/2009 |
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 |
Abbott Vascular |
NADINE SMITH |
| K090509 |
03/20/2009 |
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
NADINE SMITH |
| K090372 |
03/30/2009 |
THE WAND MICROACCESS SAFETY INTRODUCER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K090281 |
03/04/2009 |
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES |
ACCUTECH MEDICAL TECHNOLOGIES, INC. |
ANNE WORDEN |
| K083425 |
03/20/2009 |
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE |
ADAPTIVE SPECIALTY, LLC |
J.D. WEBB |
| K090478 |
03/26/2009 |
AOS PROXIMAL HUMERAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K090286 |
03/23/2009 |
PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE |
ADVANCED VASCULAR DYNAMICS |
HERBERT J SEMLER |
| K081433 |
03/26/2009 |
EK/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K083311 |
03/04/2009 |
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K083625 |
03/11/2009 |
AERO DV TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC |
TONY ALEXANDER |
| K083142 |
03/13/2009 |
PICASSO LASER SYSTEM |
AMD LASERS, LLC |
MAUREEN O'CONNELL |
| K090380 |
03/13/2009 |
MAGNUM M FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K082074 |
03/02/2009 |
ATRICURE CRYO1 CRYO-ABLATION PROBE |
ATRICURE, INC. |
JAMES LUCKY |
| K083780 |
03/23/2009 |
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 |
AUDIO TECHNOLOGIES S.R.L. |
FRANCO BEONI |
| K083858 |
03/17/2009 |
BOND BONE |
AUGMA BIOMATERIALS, LTD. |
DAVID J COLLETTE |
| K090141 |
03/17/2009 |
PRONTOSAN ANTIMICROBIAL WOUND GEL |
B. BRAUN MEDICAL, INC. |
LISA GIAQUINTO |
| K082487 |
03/04/2009 |
M-50 SERIES SPO2 SENSOR |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K090433 |
03/25/2009 |
I_OPEN 0.4T |
BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. |
|
| K090508 |
03/26/2009 |
THE BELMONT BUDDY LITE FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K083720 |
03/20/2009 |
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K |
BIEN-AIR SURGERY SA |
HUGUES FROIDEVAUX |
| K082190 |
03/11/2009 |
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K081835 |
03/19/2009 |
ACTICARE IC AND TSE |
BIOINDUCTION LIMITED |
KRISTA OAKES |
| K082346 |
03/16/2009 |
VITEK 2 GRAM NEGATIVE DORIPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K090473 |
03/25/2009 |
DISCOVERY ELBOW - X-SMALL |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K083490 |
03/18/2009 |
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 |
BIOPRO, INC. |
DAVID MRAK |
| K090501 |
03/05/2009 |
BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K090120 |
03/24/2009 |
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K082345 |
03/13/2009 |
OXYGEN DEMAND VALVE |
BPR MEDICAL, LTD. |
BEN JOHNSON |
| K081168 |
03/23/2009 |
BRIT PACS SYSTEMS |
BRIT SYSTEMS, INC. |
ROBERT MURRY |
| K090095 |
03/13/2009 |
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM |
BRONCUS TECHNOLOGIES, INC. |
MAHTAB FATEMI |
| K083869 |
03/27/2009 |
BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI |
BTLOCK SRL |
ESTHER BATTILANA |
| K082582 |
03/30/2009 |
SENTINEL, MODEL SP-001 |
C-RAD POSITIONING AB |
CRISTINA SVENSSON |
| K083675 |
03/19/2009 |
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER |
C.R. BARD, INC. |
JESSICA AGNELLO |
| K090512 |
03/27/2009 |
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER |
C.R. BARD, INC. |
ANGELA M BRADY |
| K090547 |
03/18/2009 |
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U |
C.R. BARD, INC. |
CINDY MOSS |
| K083185 |
03/11/2009 |
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1 |
CADI SCIENTIFIC PTE.LTD |
STEPHEN H GORSKI |
| K083722 |
03/31/2009 |
ASCEND |
CALDERA MEDICAL, INC. |
MARA KORSUNSKY |
| K090623 |
03/24/2009 |
DIGITAL RADIOGRAPHY CXDI-40G COMPACT |
CANON U.S.A., INC. |
SHEILA DRISCOLL |
| K090466 |
03/23/2009 |
DIGITAL RETINAL CAMERA, CR-1 MARK II |
CANON, INC. |
SHEILA DRISCOLL |
| K090272 |
03/18/2009 |
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) |
CARDINAL HEALTH, INC. |
GINA RAJTEROWSKI |
| K090521 |
03/20/2009 |
DIAMONDBACK 360 DBX |
CARDIOVASCULAR SYSTEMS, INC. |
David Brooke |
| K090439 |
03/25/2009 |
FORUM |
CARL ZEISS MEDITEC, INC. |
KENT W JONES |
| K090634 |
03/23/2009 |
PHASEAL PROTECTOR P14, P21, P28 AND P50 |
CARMEL PHARMA AB. |
KJELL ANDREASSON |
| K083892 |
03/19/2009 |
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K083612 |
03/04/2009 |
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K083607 |
03/04/2009 |
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K090229 |
03/13/2009 |
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV |
CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. |
BOB LEIKER |
| K083433 |
03/18/2009 |
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| K090100 |
03/11/2009 |
SOFTSEAL-STF |
CHITOGEN, INC. |
JANNA BEREUTER |
| K083596 |
03/02/2009 |
REEKROSS FAMILY OR OTW PTA CATHETERS |
CLEARSTREAM TECHNOLOGIES, LTD. |
FIONA N MHULLAIN |
| K090348 |
03/04/2009 |
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET |
Codman & Shurtleff, Inc. |
SHARON MCDERMOTT |
| K083024 |
03/27/2009 |
HYLATOPIC EMOLLIENT FOAM |
COLLEGIUM PHARMACEUTICAL INCORPORATED |
RONALD M GURGE |
| K083224 |
03/24/2009 |
CPI RAD VISION, MODEL VZW2944XX-YY |
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
NORM MORIKAWA |
| K083677 |
03/10/2009 |
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 |
COMMWELL LTD. |
JONATHAN KAHAN |
| K083161 |
03/27/2009 |
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) |
CONMED LINVATEC |
SUE DAUTERMAN |
| K090128 |
03/19/2009 |
TAC-TITE (TM) |
CORE ESSENCE ORTHOPAEDICS, INC. |
SHAWN T HUXEL |
| K083776 |
03/05/2009 |
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K083791 |
03/04/2009 |
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K083325 |
03/09/2009 |
N-600X WITH SPD, OXIMAX N-600X |
COVIDIEN |
SCOTT D DICKERHOFF |
| K090419 |
03/09/2009 |
SILS STITCH ENDOSCOPIC SUTURING DEVICE |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K081424 |
03/19/2009 |
AFFIRM CO2 AND AFFIRM CO2 HP |
CYNOSURE, INC. |
GEORGE CHO |
| K090235 |
03/17/2009 |
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE |
CYNOSURE, INC. |
GEORGE CHO |
| K090106 |
03/31/2009 |
PRELUDE ONE |
DANVILLE MATERIALS, INC. |
LINDSAY TILTON |
| K083182 |
03/04/2009 |
DATACOM DC PACS |
DATACOM TECHNOLOGY CORP. |
JEN KE-MIN |
| K090233 |
03/05/2009 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
JIM RASKOB |
| K090481 |
03/19/2009 |
DEMASQ IMAGING SPFTWARE DEVICE |
DEMASQ LIMITED |
STUART GALL |
| K083543 |
03/06/2009 |
DENOVISMED DENTAL IMPLANT SYSTEMS |
DENOVIS MEDICAL, LLC |
KEVIN A THOMAS |
| K090454 |
03/20/2009 |
ALLURE MB CERAMIC BRACKETS |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K090124 |
03/11/2009 |
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
ZHENG LIU |
| K090492 |
03/31/2009 |
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K083789 |
03/23/2009 |
ACE FISCHER EXTERNAL FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K083642 |
03/06/2009 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR |
| K083843 |
03/20/2009 |
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K090374 |
03/11/2009 |
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K090230 |
03/06/2009 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K090664 |
03/23/2009 |
DEVON ACCUBP CUFF |
DEVON MEDICAL INC. |
RUTH WU |
| K083532 |
03/10/2009 |
ADX4000-L, DX3000-L |
DEXCOWIN CO., LTD |
CLAUDE YANG |
| K090073 |
03/06/2009 |
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K083649 |
03/09/2009 |
CARDIUS 3 X-ACT |
DIGIRAD CORP. |
Joel Tuckey |
| K083320 |
03/06/2009 |
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE |
DUKAL CORP. |
JIM VILARDI |
| K082899 |
03/10/2009 |
DYNAMIPEAK PEAK FLOW METER |
DYNAMITECH MEDICAL, INC |
KEITH LOWREY |
| K082465 |
03/25/2009 |
EVERON |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K082039 |
03/20/2009 |
SYNCHRO HP PLATFORM |
EL.EN. ELECTRONIC ENGINEERING SPA |
ANDREA TOZZI |
| K083478 |
03/17/2009 |
SMOOTHLIPO |
ELEME MEDICAL, INC. |
MICHAIL PANKRATOV, MD |
| K083651 |
03/13/2009 |
REVELATION STEM, MODEL 427-21/42-080/180 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K083788 |
03/03/2009 |
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR |
ENDO OPTIKS, INC. |
DONALD R WATSON |
| K090310 |
03/24/2009 |
EQUIVABONE |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K083615 |
03/16/2009 |
EUROIMMUN ANTI BP 180-4X ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K083342 |
03/12/2009 |
ORBITAL RECONSTRUCTIVE IMPLANT II |
EVERA MEDICAL, INC. |
RANDY KESTEN |
| K083825 |
03/19/2009 |
EOI SPINAL SYSTEM |
EXPANDING ORTHOPEDICS, INC. |
JANICE M HOGAN |
| K083122 |
03/04/2009 |
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 |
FISHER & PAYKEL HEALTHCARE, LTD. |
STEPHANIE COSTE |
| K083832 |
03/16/2009 |
ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K083697 |
03/19/2009 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K083750 |
03/23/2009 |
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ROBERT L CASARSA |
| K083471 |
03/03/2009 |
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 |
GENERIC MEDICAL DEVICE, INC. |
MONICA MONTANEZ |
| K083389 |
03/26/2009 |
COALITION SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K090026 |
03/31/2009 |
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K090495 |
03/27/2009 |
TRUEBALANCE BLOOD GLUCOSE SYSTEM |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K090610 |
03/13/2009 |
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM |
HOSPIRA, INC. |
Yuliya Matlin |
| K090108 |
03/19/2009 |
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR |
HOVEROUND CORP. |
TONY DIGIOVANNI |
| K081346 |
03/23/2009 |
HOYA IS INJECTOR SYSTEM |
HOYA SURGICAL OPTICS, INC. |
STEVEN L ZIEMBA |
| K090223 |
03/31/2009 |
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 |
ICAD, INC. |
JOHN A DELUCIA |
| K083192 |
03/04/2009 |
INCLUSIVE TITANIUM ABUTMENT BLANKS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
| K083511 |
03/03/2009 |
ENVIRO SHARP SOLUTIONS 3 |
INDUSTRIAL WATER SOLUTIONS, INC |
THOMAS P STEWART |
| K081740 |
03/12/2009 |
HEMOBAND, MODELS HB-NS AND HB-NSXL |
INNOVATIONS FOR ACCESS, INC. |
HAL J OIEN |
| K083908 |
03/06/2009 |
BLACK NITRILE EXAMINATION GLOVES |
INNOVATIVE GLOVES CO; LTD |
RAJEEV K SOOD |
| K082853 |
03/23/2009 |
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR |
INSPIRED TECHNOLOGIES, INC. |
PAUL DRYDEN |
| K083518 |
03/13/2009 |
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K083414 |
03/02/2009 |
RADIONICS XKNIFE HDRT SYSTEM |
INTEGRA RADIONICS, INC. |
KEVIN O'CONNELL |
| K082147 |
03/20/2009 |
BODYMETRIX BX2000 |
INTELAMETRIX, INC |
HEIDI STARK |
| K083081 |
03/04/2009 |
MODIFICATION TO SECURACATH, MODEL: SPK01 |
INTERRAD MEDICAL, INC. |
Sew-Wah Tay |
| K083919 |
03/13/2009 |
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEVE CAMP |
| K080611 |
03/04/2009 |
MESA SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K080852 |
03/30/2009 |
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K083357 |
03/04/2009 |
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
KCI USA, INC. |
CHRISTY H OVIATT |
| K083609 |
03/06/2009 |
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE |
KFX MEDICAL |
GAYLE HIROTA |
| K090067 |
03/24/2009 |
BACTRACK SELECT BREATHALYZER, MODEL S80 |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
| K083801 |
03/19/2009 |
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
| K083234 |
03/25/2009 |
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
| K082177 |
03/27/2009 |
KIMGUARD ONE-STEP STERILIZATION WRAP |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
| K083432 |
03/31/2009 |
DRILL FREE MMF SCREW |
KLS MARTIN L.P. |
TOM FAUCET |
| K082614 |
03/06/2009 |
EVOX ELECTRO DIAGNOSTIC DEVICE |
LABORIE MEDICAL TECHNOLOGIES, INC. |
BARBARA MORNET |
| K090252 |
03/04/2009 |
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K083206 |
03/10/2009 |
LOUSEBUSTER |
LARADA SCIENCES |
PHIL TRIOLO |
| K083909 |
03/18/2009 |
SPINAL INJECTION SYSTEM |
LAURIMED LLC |
SEVRINA CIUCCI |
| K083891 |
03/23/2009 |
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K081269 |
03/20/2009 |
AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
| K083558 |
03/06/2009 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K081775 |
03/25/2009 |
THE MEDCOMP .010 VASCULAR GUIDEWIRES |
MEDCOMP |
LISA WEIKERT |
| K083802 |
03/20/2009 |
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K080404 |
03/13/2009 |
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR |
MEDICA CORP. |
Photios Makris |
| K082967 |
03/26/2009 |
MORTARA STRESS ECHO BED |
MEDICAL POSITIONING, INC. |
CAROL WHITE |
| K083792 |
03/25/2009 |
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 |
MEDSHAPE SOLUTIONS |
JACK GRIFFIS |
| K090659 |
03/26/2009 |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY |
MEDTRONIC INC. |
BRUCE BACKLUND |
| K090112 |
03/26/2009 |
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
JEFFERY HENDERSON |
| K081266 |
03/05/2009 |
MERCURY MEDICAL PEEP VALVE |
MERCURY ENTERPRIZES DBA MERCURY MEDICAL |
BRIAN L MORRISON |
| K083702 |
03/05/2009 |
TRACH-ASSIST |
MERGENET MEDICAL |
PAUL DRYDEN |
| K090084 |
03/06/2009 |
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN SCOTT |
| K090168 |
03/12/2009 |
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K090001 |
03/05/2009 |
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 |
MICROVENTION, INC. |
Naomi Gong |
| K090274 |
03/03/2009 |
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K090267 |
03/16/2009 |
SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 |
MIDWEST R.F. LLC. |
DAVID M PETERSON |
| K083796 |
03/09/2009 |
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT |
MILTEX, INC. |
JENNIFER J BOSLEY |
| K082819 |
03/20/2009 |
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 |
MIRAMAR LABS, INC. |
Kathy O'Shaughnessy |
| K083412 |
03/09/2009 |
PATHFAST HSCRP |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
| K090080 |
03/23/2009 |
CIRRUS OPEN |
MRI-TECH SP. ZO.O. |
ANITA CHAN |
| K083662 |
03/26/2009 |
CRITICOOL |
MTRE ADVANCED TECHNOLOGY LTD. |
IFAT OREN |
| K083493 |
03/20/2009 |
MYOSCIENCE CRYO-TOUCH |
MYOSCIENCE INC |
TRACEY HENRY |
| K062187 |
03/24/2009 |
BETACHEK GLUCOSE TEST |
NATIONAL DIAGNOSTIC PRODUCTS |
BRANDON BRANSGROVE |
| K090553 |
03/31/2009 |
NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER |
NAVISCAN, INC. |
HEATHER JALISI |
| K081851 |
03/02/2009 |
NEOSS ACCESS ABUTMENTS |
NEOSS, LTD. |
FREDRIK ENGMAN |
| K090552 |
03/16/2009 |
UROCARE |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K090410 |
03/27/2009 |
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K083456 |
03/02/2009 |
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K082719 |
03/30/2009 |
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P |
NIKKISO CO. LTD. |
FUMIAKI KANAI |
| K081970 |
03/11/2009 |
BIOCLEAN CHEMO SHIELD |
NITRITEX (M) SDN. BHD. |
DEREK WATTS |
| K082528 |
03/06/2009 |
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM |
NOBLE ANESTHESIA-AIR, INC. |
ALEXANDER B HENDERSON |
| K083341 |
03/20/2009 |
NUVASIVE HELIX-T ACP SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K081330 |
03/06/2009 |
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) |
O-TWO MEDICAL TECHNOLOGIES, INC. |
PAUL DRYDEN |
| K090259 |
03/31/2009 |
OKAMOTO ULTRA THIN |
OKAMOTO U.S.A., INC. |
JEFFERY N GIBBS |
| K081615 |
03/18/2009 |
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN |
OLYMPUS AMERICA, INC. |
STEPHANIE G DONNELLY |
| K081709 |
03/16/2009 |
OLYMPUS AFP - ALPHA-FETOPROTEIN |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE G DONNELLY |
| K090349 |
03/09/2009 |
CLEARVUE PRONE BREAST TREATMENT TABLE |
ORBITAL THERAPY, LLC |
CHAS BURR |
| K083726 |
03/11/2009 |
PEDINAIL INTRAMEDULLARY NAILING SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083830 |
03/20/2009 |
OSCAR BONE RESECTOR |
ORTHOSONICS, LTD. |
MICHAEL J YOUNG |
| K090408 |
03/20/2009 |
MODIFICATION TO: DSS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
ADAM HERDER |
| K083619 |
03/06/2009 |
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K090075 |
03/06/2009 |
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K090597 |
03/16/2009 |
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH |
PASCAL CO., INC. |
VINCENT M TENTARELLI |
| K090325 |
03/11/2009 |
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K083873 |
03/19/2009 |
PICC (CT RATED AND NON-RATED) |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K081830 |
03/16/2009 |
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
PHADIA AB |
MARTIN MANN |
| K083188 |
03/13/2009 |
VARELISA RECOMBI ANA SCREEN, MODEL 12 596 |
PHADIA US INC. |
MARTIN R MANN |
| K090483 |
03/20/2009 |
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS |
PHILIPS MEDICAL SYSTEMS |
LARRY MILANA |
| K090590 |
03/16/2009 |
VERADIUS, MODEL 718-130 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K090625 |
03/24/2009 |
WIRELESS PORTABLE DETECTOR FD-W17 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K090403 |
03/31/2009 |
AUTOSPECT |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT Z PHILLIPS |
| K082937 |
03/11/2009 |
LIFEPAK 15 MONITOR/DEFIBRILLATOR |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
| K090524 |
03/19/2009 |
GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
| K082964 |
03/09/2009 |
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) |
PRISM CLINICAL IMAGING, INC. |
JAMES L REUSS |
| K083233 |
03/02/2009 |
THE PFT FILTER |
PULMONARY FILTRATION TECHNOLOGIES LLC |
PAUL DRYDEN |
| K083688 |
03/18/2009 |
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K083749 |
03/10/2009 |
CARDIOVIEW32 REVIEW MODULE |
QRS DIAGNOSTIC, LLC. |
MARY KAY JENSEN |
| K083079 |
03/05/2009 |
QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 |
QUANTA COMPUTER INC. |
JENNIFER REICH |
| K081946 |
03/25/2009 |
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR |
QUANTEL MEDICAL |
GEORGE MYERS |
| K083763 |
03/16/2009 |
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K081978 |
03/26/2009 |
RELIANCE SPINAL SCREW SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K082594 |
03/19/2009 |
REMESENSE |
REMEDENT NV |
WILLIAM GREENROSE |
| K083575 |
03/19/2009 |
APNEALINK PLUS, MODEL: 22328 |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K083816 |
03/20/2009 |
RES TRAXX ONLINE, MODEL: R14 |
RESMED LTD. |
DAVID D'CRUZ |
| K090248 |
03/04/2009 |
BIPAP AUTOSV |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K083526 |
03/13/2009 |
TRILOGY 100 VENTILATOR |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K082558 |
03/25/2009 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
ANDREW ZELTWANGER |
| K083444 |
03/18/2009 |
C-REACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KATHIE J GOODWIN |
| K083766 |
03/02/2009 |
PHOGLASS CEM |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K083062 |
03/12/2009 |
ROOT CANAL XR |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K082227 |
03/26/2009 |
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 |
SEBIA |
KAREN ANDERSON |
| K090322 |
03/17/2009 |
EASY MOVING PLUS, SM-XXHF-YY |
SEDECAL S.A. |
DANIEL KAMM |
| K090279 |
03/11/2009 |
SEDECAL, MILLENNIUM PLUS |
SEDECAL S.A. |
DANIEL KAMM |
| K083295 |
03/16/2009 |
SERIM DISINTEK GTA 2.1%, MODEL: 5164 |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K082439 |
03/23/2009 |
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT |
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD |
Diana Hong |
| K090722 |
03/31/2009 |
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM |
SHAPE MEDICAL SYSTEMS, INC |
CLARENCE JOHNSON |
| K082735 |
03/13/2009 |
STONE GRASPING BASKET, MODEL PD-T1 2115 |
SIALO TECHNOLOGY, LTD. |
AHAVA STEIN |
| K083755 |
03/05/2009 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K083906 |
03/11/2009 |
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K083463 |
03/13/2009 |
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA M KATHLEEN ENNIS |
| K083487 |
03/30/2009 |
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K083853 |
03/24/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083314 |
03/11/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083445 |
03/24/2009 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC |
SIEMENS HEALTHCARE DIAGNOSTICS |
HELEN M LEE |
| K083339 |
03/09/2009 |
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) |
Siemens Healthcare Diagnostics Inc. |
Lubomyr Shchur |
| K083114 |
03/31/2009 |
ACUSON P50 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
| K083852 |
03/23/2009 |
BIOGRAPH 16 TRUE POINT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K083886 |
03/23/2009 |
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 |
SIMPLER ONE STOP |
HAROLD BERGMAN |
| K090503 |
03/10/2009 |
ZQUIET MOUTHPIECE |
SLEEPING WELL, LLC |
YOLANDA SMITH |
| K083762 |
03/11/2009 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
MANDY COE |
| K090313 |
03/11/2009 |
PIGALILEO TKR BASE V2.3 AND CAS V4.1 |
SMITH & NEPHEW, INC. |
MANDY COE |
| K083566 |
03/03/2009 |
R3 CONSTRAINED LINER, CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K090562 |
03/18/2009 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW, INC. |
JULIE ACKER |
| K083451 |
03/04/2009 |
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
| K082689 |
03/20/2009 |
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
DAVID L ROSEN |
| K083636 |
03/02/2009 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILMED, INC. |
GARRETT AHLBORG |
| K090136 |
03/20/2009 |
STERIS CMAX XLT SURGICAL TABLE |
STERIS Corporation |
JOHN ROBERT SCOVILLE |
| K090514 |
03/16/2009 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES |
STERIS Corporation |
JOHN R SCOVILLE |
| K083650 |
03/05/2009 |
EMU-GRAPH 4 EMULATOR, MODEL CI 144 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K090137 |
03/18/2009 |
STAK-CHEX PLUS RETICS |
Streck |
KERRIE OETTER |
| K090201 |
03/27/2009 |
UA-CELLULAR FOR IQ |
Streck |
KERRIE OETTER |
| K083562 |
03/25/2009 |
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
KIMBERLY LANE |
| K083020 |
03/26/2009 |
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
KIMBERLY LANE |
| K090499 |
03/31/2009 |
LIFEDOP MODEL, L350R |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K082662 |
03/26/2009 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP |
RENEE BORGESANO |
| K083263 |
03/13/2009 |
SYMCARE DIABETES MANAGEMENT PROGRAM |
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC |
RAE ANN DELAY |
| K083307 |
03/27/2009 |
SYNTHASOME X-REPAIR |
SYNTHASOME, INC. |
ANTHONY RATCLIFFE |
| K083694 |
03/06/2009 |
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES |
SYNTHES (USA) |
SHERI L MUSGUNG |
| K083573 |
03/04/2009 |
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K083388 |
03/12/2009 |
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K090395 |
03/10/2009 |
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E |
TaiDoc Technology Corporation |
Yuhua Chen |
| K090536 |
03/26/2009 |
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 |
TaiDoc Technology Corporation |
SOPHIE LIN |
| K083570 |
03/11/2009 |
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
SOPHIE LIN |
| K090020 |
03/13/2009 |
BEL-CYPHER, MODEL Y977 |
TAKARA-BELMONT CO., LTD. |
KUNIHIKO SOBUE |
| K090537 |
03/19/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K083169 |
03/30/2009 |
EPTFE SLFTM SPIRAL VASCULAR GRAFT |
TAYSIDE FLOW TECHNOLOGIES LIMITED |
EDWIN LINDSAY |
| K082499 |
03/26/2009 |
C. DIFF QUIK CHEK COMPLETE |
TECHLAB, INC. |
CHARLES PENNINGTON |
| K083005 |
03/04/2009 |
NANGEL |
TEKNIMED SA |
J.D. WEBB |
| K083620 |
03/06/2009 |
SOMNOLYZER 24X7 |
THE SIESTA GROUP NORTH AMERICA |
ZVI LADIN |
| K083073 |
03/13/2009 |
THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K083863 |
03/27/2009 |
THEKEN ATOLL OCT SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K090153 |
03/27/2009 |
SPI VARIOMULTI ANGLED ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K081953 |
03/12/2009 |
SUPERCATH 5 |
TOGO MEDIKIT CO., LTD. |
FUMIAKI KANAI |
| K081554 |
03/18/2009 |
TOKUYAMA TISSUECARE |
TOKUYAMA DENTAL CORPORATION |
KEITH BARRITT |
| K083316 |
03/13/2009 |
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
TOPCON MEDICAL SYSTEMS, INC. |
BARBARA S FANT |
| K090076 |
03/17/2009 |
SALTO TALARIS TOTAL ANKLE PROSTHESIS |
TORNIER |
SEVERINE BONNETON |
| K090504 |
03/05/2009 |
CSBP-001A BODY PERFUSION SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K083218 |
03/06/2009 |
TC ENDO PORT |
TRANSCARDIAC THERAPEUTICS, INC. |
DAVID SMITH |
| K083606 |
03/24/2009 |
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K081063 |
03/06/2009 |
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K081984 |
03/04/2009 |
LABORPRO SYSTEM |
TRIG MEDICAL LTD |
KEREN SHTIEGMAN |
| K081813 |
03/12/2009 |
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM |
U.S. IMPLANT SOLUTIONS, LLC |
SCOTT GARRETT |
| K090502 |
03/10/2009 |
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINA SMITH |
| K090083 |
03/23/2009 |
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K083784 |
03/30/2009 |
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K090214 |
03/13/2009 |
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND |
VERATHON INCORPORATED |
KRISTIAN NIELSEN |
| K081845 |
03/16/2009 |
IVENT101 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K090649 |
03/27/2009 |
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE |
VIRTUAL RADIOLOGIC CORPORATION |
KIMBERLY TOKACH |
| K090295 |
03/04/2009 |
BODYVIZ, MODEL 100 |
VISUAL MEDICAL SOLUTIONS, LLC |
J. HARVEY KNAUSS |
| K090644 |
03/31/2009 |
VITABLOCS, MODEL VX55-**** |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
ELIZABETH WOLFSEN |
| K083266 |
03/27/2009 |
GORE BIO-A FISTULA PLUG |
W.L. GORE & ASSOCIATES,INC |
BARBARA L SMITH |
| K081748 |
03/27/2009 |
ONEPLANT DENTAL IMPLANT SYSTEM |
WARANTEC CO., LTD. |
DANIEL KAMM |
| K082478 |
03/09/2009 |
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K082924 |
03/06/2009 |
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K083823 |
03/18/2009 |
SECURIAN TISSUE REINFORCEMENT MATRIX |
XYLOS CORPORATION |
JOYCE ELKINS |
| K083739 |
03/26/2009 |
HYDRORISE AND HYDROSYSTEM |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K083015 |
03/10/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD |
JOHN ZHAO |
| K083446 |
03/31/2009 |
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING |
ZIOSOFT, INC. |
RICHARD BALL |
| K081081 |
03/09/2009 |
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
