| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K093650 |
11/25/2009 |
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM |
MEDTRONIC INC. |
JEFFREY KOLL |
| K093604 |
11/20/2009 |
ETEST MOXIFLOXACIN 0.002-32 UG/ML |
AB BIOMERIEUX |
ASA KARLSSON |
| K093318 |
11/03/2009 |
ACCELERATOR APS |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K092705 |
11/17/2009 |
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 |
ABBOTT MOLECULAR, INC. |
PAULA E MARTIN |
| K093600 |
11/20/2009 |
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM |
ACCELERATED CARE PLUS |
PATRICK PARKER |
| K093594 |
11/19/2009 |
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
COURTNEY KALOF |
| K093518 |
11/13/2009 |
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K093657 |
11/25/2009 |
ADAGIO RETRACTING ECG LEAD WIRES |
ACIST MEDICAL SYSTEMS, INC. |
AL SAALABI |
| K093649 |
11/25/2009 |
AESCULAP STERILCONTAINER S |
AESCULAP |
KATHY RACOSKY |
| K093493 |
11/10/2009 |
AESCULAP STERILCONTAINER S |
AESCULAP, INC. |
KATHY RACOSKY |
| K093476 |
11/09/2009 |
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
AGA MEDICAL CORP. |
AMANDA JOHNSON |
| K093488 |
11/10/2009 |
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K093495 |
11/10/2009 |
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS |
AMERICAN DIAGNOSTIC CORP. |
MICHAEL FALCO |
| K093588 |
11/19/2009 |
EXPLORER 4D TREATMENT PLANNING SYSTEM |
AMERICAN RADIOSURGERY, INC. |
DAN OLIVIER |
| K093571 |
11/24/2009 |
ZR DENTAL BLOCK |
AMS CO., LTD |
CLAUDE YANG |
| K093452 |
11/09/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093528 |
11/16/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093406 |
11/02/2009 |
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 |
ANGIODYNAMICS, INC. |
JODI LYNN FRASIER |
| K093567 |
11/18/2009 |
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM |
ANOVA IMPLANT SOLUTIONS, LLC |
WALTER SPIRES |
| K093523 |
11/13/2009 |
MICRO-TOUCH NITRILE |
ANSELL HEALTHCARE PRODUCTS LLC |
CYNTHIA A INGRAM |
| K093579 |
11/18/2009 |
PROSTATE MECHANICAL IMAGER |
ARTANN LABORATORIES, INC |
GERARD J PRUD'HOMME |
| K093483 |
11/09/2009 |
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT |
ASTRA TECH INC. |
BETSY A BROWN |
| K093679 |
11/27/2009 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 |
ATRICURE, INC. |
JAMES LUCKY |
| K093431 |
11/04/2009 |
CLEARWAY OTW MODEL 85912 |
ATRIUM MEDICAL CORP. |
RAYMOND KELLY |
| K093458 |
11/06/2009 |
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K093678 |
11/27/2009 |
PLATELIA ASPERGILLUS EIA MODEL 62793 |
BIO-RAD |
CHRISTOPHER BENTSEN |
| K093577 |
11/18/2009 |
LIQUICHEK OPIATE CONTROL |
BIO-RAD LABORATORIES |
ELIZABETH PLATT |
| K093630 |
11/27/2009 |
BIODENTA DENTAL IMPLANT SYSTEM |
BIODENTA SWISS AG |
DAVID EILER |
| K093549 |
11/17/2009 |
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K093629 |
11/23/2009 |
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K093455 |
11/05/2009 |
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES |
BIOSENSE WEBSTER, INC. |
BALAKA DAS |
| K093566 |
11/18/2009 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K093470 |
11/06/2009 |
CORE-FLO D/C |
BISCO, INC. |
MICHELLE SCHILTZ-TAING |
| K093691 |
11/30/2009 |
ACCUMAX |
BOSTON SCIENTIFIC CORP. |
NICHOLE RIEK |
| K093636 |
11/24/2009 |
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX |
BOSTON SCIENTIFIC CORP. |
SHANNON PETTIT |
| K093515 |
11/13/2009 |
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON |
BRIVANT, LTD. |
TOMAS FUREY |
| K093423 |
11/03/2009 |
LUNGPOINT PROCEDURE PLANNING |
BRONCUS TECHNOLOGIES, INC. |
NANCY ISAAC |
| K093665 |
11/25/2009 |
ENDO SMARTCAP |
BYRNE MEDICAL INC. |
DON BYRNE |
| K093659 |
11/25/2009 |
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 |
C.R. BARD, INC. |
JONI CREAL |
| K093663 |
11/25/2009 |
RADIONUCLIDE BRACHYTHERAPY SOURCE |
C.R. BARD, INC. |
JULIE BASSETT |
| K093463 |
11/06/2009 |
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 |
CAREFUSION |
SHARON NICHOLS |
| K093616 |
11/19/2009 |
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART |
CAREFUSION 2200 |
GINA RAJTEROWSKI |
| K093521 |
11/13/2009 |
GDXPRO |
CARL ZEISS MEDITEC INC |
JUDY A BRIMACOMBE |
| K093696 |
11/30/2009 |
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K093565 |
11/18/2009 |
PLEURAFLOW CATHETER SYSTEM |
CLEAR CATHETER SYSTEMS |
MONICA DOUGHERTY |
| K093557 |
11/16/2009 |
SMARTWAND-DTX |
CLEARCOUNT MEDICAL SOLUTIONS |
JEFF WOLFGONG |
| K093610 |
11/20/2009 |
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K093513 |
11/17/2009 |
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
AMITA SHAH, RAC |
| K093556 |
11/17/2009 |
VCARE DX |
CONMED CORPORATION |
SARAH RIZK |
| K093619 |
11/23/2009 |
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E |
COOK IRELAND LTD |
JACINTA KILMARTIN |
| K093469 |
11/06/2009 |
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS |
COOK, INC. |
SUSANNE GALIN |
| K093472 |
11/06/2009 |
TRINITY ACETABULAR SYSTEM |
CORIN U.S.A. |
ASHLEA BOWEN |
| K093480 |
11/09/2009 |
CUATTRO UNOMD |
CUATTRO, LLC |
MARK SKEELS |
| K093474 |
11/06/2009 |
DEPUY FRACTURE AND FUSION PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K093646 |
11/25/2009 |
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MEYER |
| K093415 |
11/02/2009 |
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
RONALD H LOLLAR |
| K093492 |
11/11/2009 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K093498 |
11/12/2009 |
LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 |
DIASORIN, INC. |
CAROL A DEPOUW |
| K093680 |
11/27/2009 |
DIAZYME CYSTATIN C ASSAY |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K093587 |
11/19/2009 |
DENTAL MERCURY |
DMG USA, INC. |
PAMELA PAPINEAU |
| K093465 |
11/10/2009 |
FUSION SYSTEM |
ECLIPSEMED GLOBAL, INC |
IGOR GRADOV |
| K093554 |
11/21/2009 |
RETROFLEX DILATOR KIT |
EDWARDS LIFESCIENCES, LLC. |
JASON K LYON |
| K093622 |
11/23/2009 |
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 |
ENCISION, INC. |
JUDITH V KING |
| K093613 |
11/23/2009 |
VASCUVIEW TAP ULTRASOUND SYSTEM |
ESCALON MEDICAL CORP. |
ROGER EDENS |
| K093681 |
11/27/2009 |
MERIDIAN GUIDEWIRE |
EV3 NEUROVASCULAR |
DEBORAH BAKER-JANIS |
| K093430 |
11/03/2009 |
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. |
EXACTECH, INC. |
GRAHAM CUTHBERT |
| K093427 |
11/03/2009 |
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K093608 |
11/20/2009 |
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K093514 |
11/13/2009 |
DISCOVERY MODEL NM/CT 670 |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
| K093581 |
11/18/2009 |
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS |
GE MEDICAL SYSTEMS, LLC |
TRACEY ORTIZ |
| K093694 |
11/30/2009 |
GERATHERM UNIQUERESC |
GERATHERM MEDICAL AG |
ANDREA PECSI |
| K093575 |
11/18/2009 |
GLUMA DESENSITIZER POWER GEL |
HERAEUS KULZER, LLC |
CHERYL V ZIMMERMAN |
| K093466 |
11/06/2009 |
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGH THISTLETHWAITE |
| K093644 |
11/25/2009 |
RESTORATION ADM SYSTEM X3 ACETABULAR |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL MARGULIES |
| K093433 |
11/04/2009 |
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K093639 |
11/24/2009 |
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 |
HUVITZ CO., LTD. |
MATEW J WESS |
| K093475 |
11/06/2009 |
BASESENS BLOOD GLUCOSE MONITORING SYSTEM |
HYGEIA, INC. |
ROBERT J BARD |
| K093545 |
11/17/2009 |
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W |
INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) |
ANNE WORDEN |
| K093564 |
11/18/2009 |
SVED WOUND TREATMENT SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
| K093669 |
11/27/2009 |
SEC IBF CAGE |
INNVOTEC SURGICAL, INC. |
JUSTIN EGGLETON |
| K093399 |
11/02/2009 |
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 |
INRAD |
MELISSA LALOMIA |
| K093683 |
11/30/2009 |
ORTHOPANTOMOGRAPH OP300 |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
MATTI TULIKOURA |
| K093623 |
11/23/2009 |
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K093642 |
11/24/2009 |
NEUTRASAL |
INVADO PHARMACEUTICALS |
EDWARD D KOBUS |
| K093576 |
11/18/2009 |
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K093570 |
11/18/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR |
JIANGSU JAYSUN GLOVE CO., LTD. |
CHU XIAOAN |
| K093637 |
11/24/2009 |
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 |
JMS NORTH AMERICA CORP. |
E J SMITH |
| K093534 |
11/16/2009 |
MODIFICATION TO CASPIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K093471 |
11/06/2009 |
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K093603 |
11/30/2009 |
STORM-BASE 2.0 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
LEIGH SPOTTEN |
| K093526 |
11/16/2009 |
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
RANDALL WHEELAND |
| K093473 |
11/06/2009 |
KMD-MARK1 TISSUE MARKER |
KENT MEDICAL DEVICES, INC. |
JUSTIN EGGLETON |
| K093484 |
11/09/2009 |
PREMISE FLOWABLE MODIFIED |
KERR CORPORATION |
WENDY GARMAN |
| K093499 |
11/12/2009 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CHERITA JAMES |
| K093662 |
11/25/2009 |
ECHOBRIGHT |
LIFE-TECH, INC. |
JEFF KASOFF |
| K093485 |
11/10/2009 |
VESISCAN |
LIFE-TECH, INC. |
JEFF KASOFF |
| K093420 |
11/18/2009 |
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K093596 |
11/25/2009 |
LUMOS, MODEL R 72B |
LUMOS, INC |
DANIEL KAMM |
| K093537 |
11/16/2009 |
HANAROSTENT ESOPHAGUS (CCC) |
M.I. TECH CO., LTD. |
BRANDON CHOI |
| K093425 |
11/03/2009 |
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K093522 |
11/16/2009 |
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C |
MAQUET CARDIOPULMONARY AG |
FRANK MOEHRKE |
| K093533 |
11/19/2009 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 |
MATERIALISE N.V. |
KARL VOM BERGE |
| K093548 |
11/17/2009 |
AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
| K093409 |
11/04/2009 |
POWERPUMP ARTHROSCOPY SYSTEM |
MEDICAL VISION AB |
CONSTANCE G BUNDY |
| K093444 |
11/05/2009 |
EXAPACS |
MEDINCOM TECHNOLOGY CORP |
ANDREW LEE |
| K093593 |
11/19/2009 |
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO |
MEDTRADE PRODUCTS LIMITED |
JONATHAN RANFIELD |
| K093519 |
11/13/2009 |
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K093535 |
11/16/2009 |
AUTOLOG AUTOTRANSFUSION SYSTEM |
MEDTRONIC INC. |
CARALEE WALTON |
| K093434 |
11/04/2009 |
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA L WEISMAN |
| K093520 |
11/13/2009 |
VIVOSIGHT TOPICAL OCT SYSTEM |
MICHELSON DIAGNOSTICS LTD. |
MARTIN JOHNS |
| K093647 |
11/25/2009 |
TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
NAOMI GONG |
| K093544 |
11/17/2009 |
TROPAZONE CR |
MIDLOTHIAN LABORATORIES |
BRYCE HARVEY |
| K093449 |
11/11/2009 |
MINI LAP RETRACTORS |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K093479 |
11/18/2009 |
DISPOSABLE SUCTION AND IRRIGATION SYSTEM |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
EUGENE YEUNG |
| K093689 |
11/30/2009 |
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS |
MR MEDICAL SOLUTIONS LLC |
FAHAD ALRADADY |
| K093584 |
11/19/2009 |
EZ-MISTER |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K093329 |
11/30/2009 |
SCOPE INTRODUCER MODEL 7400 |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K093661 |
11/25/2009 |
COLONRING |
NITI SURGICAL SOLUTIONS LTD |
JONATHAN KAHAN |
| K093693 |
11/30/2009 |
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K093585 |
11/20/2009 |
MICROCYN SKIN AND WOUND HYDROGEL |
OCULUS INNOVATIVE SCIENCES, INC. |
ANTOINETTE DOUGLAS |
| K093507 |
11/13/2009 |
OLYMPUS CHF TYPE Y0003 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K093395 |
11/04/2009 |
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K093572 |
11/18/2009 |
R650 QDASM COLLIMATOR |
OMEGA MEDICAL IMAGING, INC. |
JAMES PRINCEHORN |
| K093451 |
11/05/2009 |
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K093496 |
11/10/2009 |
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT |
OON CORP. RESOURCES |
JANNA P TUCKER |
| K092837 |
11/30/2009 |
OTI-SCAN 3000 |
OPKO INSTRUMENTATION, INC |
MARIO ARBESU |
| K093624 |
11/23/2009 |
OPTISCAN MODEL OPTISCAN CEIS |
OPTISCAN PTY LTD. |
PETER PAVLICEK |
| K093595 |
11/23/2009 |
CERAROOT IMPLANT SYSTEM |
ORAL ICEBERG S.L. |
STUART R GOLDMAN |
| K093611 |
11/23/2009 |
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
MARLENE A HANNA |
| K093442 |
11/05/2009 |
GUIDED GROWTH SYSTEM |
ORTHOFIX INC. |
MARY BIGGERS |
| K093438 |
11/04/2009 |
PARADIGM INTERSPINOUS FUSION PLATE |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K093494 |
11/10/2009 |
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM |
PATHFINDER THERAPEUTICS, INC. |
CRAIG HENDERSON |
| K093456 |
11/05/2009 |
JETSTREAM G3 SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
CYNDY ADAMS |
| K093695 |
11/30/2009 |
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K093553 |
11/17/2009 |
POSTURETEK |
PERSEUS ALTHETICS,LLC |
KEITH BARRITT |
| K093459 |
11/06/2009 |
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
PHADIA US INC. |
MARTIN ROBERT MANN |
| K093426 |
11/03/2009 |
BACT-TRAP HEPA MIDI |
PHARMA SYSTEMS AB |
PAUL DRYDEN |
| K093563 |
11/18/2009 |
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS |
PHILIPS ULTRASOUND, INC. |
NANCY BURKE |
| K093618 |
11/23/2009 |
BILI-MIRROR MODEL BLM-1 |
PHYSICIAN ENGINEERED PRODUCTS, INC. |
ROB ROSE, MD |
| K093547 |
11/17/2009 |
PINPOINTE FOOTLASER |
PINPOINTE USA, INC. |
ANNE WORDEN |
| K093692 |
11/30/2009 |
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES |
PIONEER SURGICAL TECHNOLOGY |
EMILY M DOWNS |
| K093590 |
11/19/2009 |
PLANMECA PROMAX 3D MAX |
PLANMECA OY |
LARS MORING |
| K093620 |
11/24/2009 |
PULPDENT FLUORIDE VARNISH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K093697 |
11/30/2009 |
VASHE WOUND THERAPY SOLUTION |
PURICORE INC. |
DENNIS MAHONRY |
| K093667 |
11/27/2009 |
SHOULDER SPEEDER COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K093658 |
11/25/2009 |
RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS |
RENU MEDICAL, INC. |
L. BRUCE PIERSON |
| K093684 |
11/30/2009 |
EASYCARE ONLINE |
RESMED LTD. |
DAVID D'CRUZ |
| K093416 |
11/02/2009 |
TRILOGY 200 VENTILATOR |
RESPIRONICS, INC. |
ZITA YURKO |
| K093460 |
11/06/2009 |
COAGUCHEK XS PRO SYSTEM |
ROCHE DIAGNOSTICS |
JENNIFER TRIBBETT |
| K093555 |
11/19/2009 |
COBAS U411 TEST SYSTEM |
ROCHE DIAGNOSTICS |
JENNIFER TRIBBETT |
| K093582 |
11/19/2009 |
ELECSYS CK-MB CALCHECK 5 |
ROCHE DIAGNOSTICS |
JACK ROGERS |
| K093664 |
11/27/2009 |
AMPHETAMINES II ASSAY |
ROCHE DIAGNOSTICS CORP. |
MICHELLE L NEFF |
| K093421 |
11/09/2009 |
ELECSYS TESTOSTERONE II IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
SARAH BAUMANN |
| K093489 |
11/10/2009 |
IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY |
RYMED TECHNOLOGIES, INC. |
JOSEPH AZARY |
| K093453 |
11/05/2009 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
HOWARD FIDEL |
| K093512 |
11/13/2009 |
ENCOR BREAST BIOPSY SYSTEM |
SENORX, INC. |
EBEN GORDON |
| K093672 |
11/27/2009 |
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION |
SENTINELLE MEDICAL, INC. |
JOAN MEDLEY |
| K093560 |
11/21/2009 |
UPCERA ZIRCONIA BLANKS |
SHENYANG UPCERA CO., LTD. |
STUART R GOLDMAN |
| K093559 |
11/18/2009 |
VINTAGE MP |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K093612 |
11/23/2009 |
SYNGO.PLAZA |
SIEMENS AG, MEDICAL SOLUTIONS |
|
| K093631 |
11/24/2009 |
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE KATHLEEN ENNIS |
| K093441 |
11/05/2009 |
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 |
SIEMENS HEALTHCARE DIAGNOSTICS |
FRANCES A DILLON |
| K093645 |
11/25/2009 |
EXL ANEM CAL, MODEL RC640 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA M KATHLEEN ENNIS |
| K093621 |
11/23/2009 |
SYNGO.PET&CT ONCOLOGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K093531 |
11/16/2009 |
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
SHELLY PEARCE |
| K093648 |
11/25/2009 |
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION |
SIMPLISSE INC. |
GLEN FEYE |
| K093407 |
11/09/2009 |
ZQUIET MOUTHPIECE |
SLEEPING WELL, LLC |
YOLANDA SMITH |
| K093550 |
11/17/2009 |
MINI RAIL EXTERNAL FIXATOR SYSTEM |
SMALL BONE INNOVATIONS, INC. |
JOHN MINIER |
| K093428 |
11/03/2009 |
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHY REDDIG |
| K093414 |
11/04/2009 |
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS |
SMITHS MEDICAL ASD, INC. |
RACHELLE PARSONS |
| K093422 |
11/03/2009 |
VITAL SYNC MODEL 5000 SERIES |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K093510 |
11/12/2009 |
LUMENVU CATHETER GUIDANCE SYSTEM |
SONOSITE,INC. |
JANICE HOGAN |
| K093601 |
11/20/2009 |
AF 840 PH.I.S.I.O. ARTERIAL FILTER |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K093511 |
11/13/2009 |
SORING MBC200/BCC140 |
SORING GMBH MEDIZINTECHNIK |
JAN SCHUELLER-IWERSEN |
| K093477 |
11/09/2009 |
SHIELD KYPHOPLASTY SYSTEM |
SOTEIRA, INC. |
PAMELA PAPINEAU |
| K093562 |
11/18/2009 |
ENDOSSEOUS DENTAL IMPLANT |
SOUTHERN IMPLANTS, INC. |
MICHAEL KEHOE |
| K093501 |
11/12/2009 |
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION |
SPACELABS MEDICAL INC. |
DAVID GERAGHTY |
| K093551 |
11/17/2009 |
PARADIS VASO SHIELD |
SPINEMEDICA, LLC |
SALLY THORSEN |
| K093583 |
11/19/2009 |
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE |
ST. JUDE MEDICAL |
TIM KAPPERS |
| K093677 |
11/27/2009 |
STRYKER ARTHROSCOPE |
STRYKER ENDOSCOPY |
SHIBIR DESAI |
| K093419 |
11/02/2009 |
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
BECKY E DITTY |
| K093670 |
11/27/2009 |
MODIFICATION TO: OASYS SYSTEM |
STRYKER SPINE |
PAULINE SHAND |
| K093516 |
11/13/2009 |
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES |
SUMMIT GLOVE, INC. |
JAMES MOORE |
| K093517 |
11/13/2009 |
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE |
SUMMIT GLOVE, INC. |
JAMES MOORE |
| K093408 |
11/02/2009 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
NISHITH DESAI |
| K093410 |
11/02/2009 |
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY |
SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE |
FRANK GIANELLI |
| K093402 |
11/02/2009 |
AUTOSUTURE EEA ORVIL |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO |
REBECCA RONNER |
| K093491 |
11/18/2009 |
HIP SEXTANT INSTRUMENT SYSTEM |
SURGICAL PLANNING ASSOCIATES |
JOSEPH AZARY |
| K093464 |
11/06/2009 |
RAPIDSORB PLUS SCREW SYSTEM |
SYNTHES (USA) |
JEFFREY DOW |
| K093668 |
11/27/2009 |
SYNTHES MATRIX MIS RODS |
SYNTHES (USA) |
HEATHER GUERIN |
| K093592 |
11/19/2009 |
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 |
TAIDOC TECHNOLOGY CORPORATION |
DEBRA LIANG |
| K093506 |
11/12/2009 |
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 |
TAIDOC TECHNOLOGY CORPORATION |
TELING HSU |
| K093635 |
11/23/2009 |
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS |
TAIDOC TECHNOLOGY CORPORATION |
DEBRA LIANG |
| K093641 |
11/24/2009 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
LORI HOLDER |
| K093439 |
11/04/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN PUFA PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
| K093497 |
11/12/2009 |
THD BANDY |
THD SPA |
GUIDO BONAPACE |
| K093615 |
11/23/2009 |
SPI DENTAL IMPLANT, ELEMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K093546 |
11/17/2009 |
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX |
TOGO MEDIKIT CO., LTD. |
FUMIAKI KANAI, PH.D |
| K093676 |
11/27/2009 |
OMNITECH LARGE, TRIMED COMPRESSION SCREW |
TRIMED, INC. |
KELLI ANDERSON |
| K093478 |
11/10/2009 |
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K093524 |
11/16/2009 |
PIVIT A/B ST AND PIVIT A/B ST-R |
TYRX ,INC |
MARK CITRON |
| K093462 |
11/06/2009 |
SONIX ULTRASOUND SCANNER |
ULTRASONIX MEDICAL CORPORATION |
CHAS YU |
| K093400 |
11/02/2009 |
1ML UNITRACT INSULIN SYRINGE 27G X 1/2" AND 29G X 1/2" |
UNILIFE MEDICAL SOLUTIONS LIMITED |
MELISSA L DEHASS |
| K093653 |
11/25/2009 |
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
URESIL, LLC |
LEV MELINYSHYN |
| K093527 |
11/16/2009 |
ARIA RADIATION ONCOLOGY WITH MIRS |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K093502 |
11/12/2009 |
VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K093503 |
11/12/2009 |
INTRAX FILM PROCESSOR |
VELOPEX INTERNATIONAL, INC. |
ANTHONY URELLA |
| K093525 |
11/18/2009 |
ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE |
VENTLAB CORP. |
JAMES A COCHIE |
| K093617 |
11/23/2009 |
VENTLAB 6000 SERIES HUMIDIFIER |
VENTLAB CORP. |
JAMES A COCHIE |
| K093675 |
11/27/2009 |
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 |
VERTEBRAL TECHNOLOGIES, INC. |
SURESH GHAI |
| K093446 |
11/06/2009 |
VITA VMK MASTER |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. |
ELIZABETH WOLFSEN |
| K093500 |
11/12/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
S.H. TAN |
| K093508 |
11/12/2009 |
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) |
WOMANCARE GLOBAL |
SUSANNE PARKS |
| K093552 |
11/17/2009 |
EVOLUTION MP TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K093405 |
11/02/2009 |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K093591 |
11/19/2009 |
STIMPOD MODEL NMS-400 NERVE STIMULATOR |
XAVANT TECHNOLOGY (PTY), LTD. |
BRIAN ROTHMAN |
| K093561 |
11/18/2009 |
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM |
ZIMMER, INC. |
BENJAMIN CURSON, CQE RAC |
