| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K101249 |
05/04/2010 |
STERIGAGE MODEL 1243RA, 1243RB, 1243RE |
3M COMPANY |
SUZANNE LEUNG |
| K101468 |
05/27/2010 |
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE |
3M COMPANY CORP |
LINDA JOHNSON |
| K101427 |
05/21/2010 |
AUDIT MICROCV HS-CRP LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K101434 |
05/21/2010 |
AUDIT MICROCV PROCALCITONIN LINEARITY |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K101226 |
05/03/2010 |
AUDIT MICROCV RF/CRP LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K101374 |
05/17/2010 |
AAXTER A3 POSTERIOR SPINAL SYSTEM |
AAXTER CO., LTD |
JACK CHEN |
| K101422 |
05/20/2010 |
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K101371 |
05/17/2010 |
ON CALL PLUS DIABETES MONITORING SOFTWARE |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K101281 |
05/06/2010 |
VEGA KNEE SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
KATHY A RACOSKY |
| K101348 |
05/13/2010 |
AGACHAMBER SPACER |
AGAPLASTIC IND. COM. LTDA. |
MARIA F GRIFFIN |
| K101454 |
05/25/2010 |
MAMMAPRINT |
AGENDIA |
Guido Brink |
| K101289 |
05/07/2010 |
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB |
AIR TECHNIQUES, INC. |
PABLO MARTINEZ |
| K101285 |
05/07/2010 |
CONSTELLATION VISION SYSTEM |
ALCON MANUFACTURING, LTD. |
MARTIN KAUFMAN |
| K101255 |
05/04/2010 |
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM |
ALPHATEC SPINE, INC. |
KARLA SCHAFFNER |
| K101220 |
05/03/2010 |
EXPLORER 4D TREATMENT PLANNING SYSTEM |
AMERICAN RADIOSURGERY, INC. |
DAN OLIVER |
| K101307 |
05/10/2010 |
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K101291 |
05/07/2010 |
SCANVIEW HER2/NEU FISH SYSTEM |
APPLIED SPECTRAL IMAGING, LTD. |
DAN LAOR |
| K101305 |
05/10/2010 |
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL |
ARK DIAGNOSTICS,INC |
JOHNNY VALDEZ |
| DEN100016 |
05/21/2010 |
PROSTATE MECHANICAL IMAGER |
ARTANN LABORATORIES, INC |
GERARD J PRUD'HOMME |
| K101448 |
05/24/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K101437 |
05/24/2010 |
SPEEDFIX SUTURE SYSTEM |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K101351 |
05/14/2010 |
NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT |
ASCEND EAGLE, INC. |
JANNA P TUCKER |
| K101332 |
05/12/2010 |
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 |
ASEPTICO, INC. |
CHERIE A TREGONING |
| K101392 |
05/18/2010 |
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D |
ASTORIA-PACIFIC,INC. |
JASON C REYNOLDS |
| K101355 |
05/14/2010 |
AUGEASE VASCULAR AUGMENTATION DEVICE |
AUGDVT LLC |
E. J. SMITH |
| K101325 |
05/12/2010 |
STELLARIS PC VISION ENHANCEMENT SYSTEM |
BAUSCH & LOMB, INC. |
NED LUCE |
| K101385 |
05/18/2010 |
DUAL LUER LOCK CAP, MODEL 2C6250 |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K101372 |
05/17/2010 |
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K101461 |
05/26/2010 |
BD DIRECTIGEN EX FLU A+B |
Becton, Dickinson and Company |
GREGORY PAYNE |
| K101481 |
05/28/2010 |
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET |
BIOMERS PRODUCTS, LLC |
GEORGE ALIPHTIRAS |
| K101475 |
05/28/2010 |
COMPRESS ANTI-ROTATION SPINDLES |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
| K101336 |
05/12/2010 |
E1 AVANTAGE HEAD |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K101345 |
05/13/2010 |
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K101398 |
05/18/2010 |
STEREOS WORKSTATION |
BIOSPACE MED |
JOHN J SMITH |
| K101282 |
05/06/2010 |
SCOUTPRO HEMOSTATIC VALVE |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K101485 |
05/28/2010 |
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E |
BISCO, INC. |
MICHELLE SCHULTZ- TAING |
| K101314 |
05/11/2010 |
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
ELENA NIEVES |
| K101331 |
05/11/2010 |
LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
ANASTASIA C RANDALL |
| K101261 |
05/05/2010 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
Mark Nelson |
| K101431 |
05/21/2010 |
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS |
C.R. BARD, INC. |
Joni Creal |
| K101231 |
05/03/2010 |
CABOCHON SYSTEM |
CABOCHON AESTHETICS, INC. |
BEN BRIAN |
| K101462 |
05/26/2010 |
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K101452 |
05/25/2010 |
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW |
CAPINTEC, INC. |
MARY ANNE DELL |
| K101301 |
05/10/2010 |
STALIF MIDLINE |
CENTINEL SPINE |
JUSTIN EGGLETON |
| K101429 |
05/21/2010 |
ECO SUPERGEL |
CERACARTA SPA |
ELAINE DUNCAN |
| K101400 |
05/18/2010 |
LOCKING COMPRESSION PLATE |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K101487 |
05/28/2010 |
CHEETAH NICOM SYSTEM |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K101276 |
05/06/2010 |
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 |
CHEMENCE MEDICAL PRODUCTS INC. |
PATRICIA LEHMAN |
| K101366 |
05/17/2010 |
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) |
CHROMOGENEX TECHNOLOGIES LTD |
PETER R BEVAN |
| K101411 |
05/19/2010 |
SAVI PREPARATION DEVICE |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K101361 |
05/14/2010 |
REEFLEX PTA CATHETER |
CLEARSTREAM TECHNOLOGIES, LTD. |
FIONA N MHULLAIN |
| K101439 |
05/24/2010 |
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P |
CODONICS, INC. |
GARY W ENOS |
| K101297 |
05/10/2010 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 |
COLOPLAST A/S |
ANGELA BYLAND |
| K101273 |
05/06/2010 |
DYNAMIC ECG SYSTEM MODEL TLC5000 |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K101450 |
05/24/2010 |
CANTATA MICROCATHETER |
COOK, INC. |
MIRONDA CARPENTER |
| K101484 |
05/28/2010 |
COMPRESSYN BAND |
DALLEN MEDICAL |
AL MEMMOLO |
| K101240 |
05/04/2010 |
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K101433 |
05/21/2010 |
DEPUY ATTUNE KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
KATHY BOGGS |
| K101421 |
05/20/2010 |
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K101368 |
05/17/2010 |
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES |
DRAGON HEART MEDICAL, INC. |
JINA YU |
| K101482 |
05/28/2010 |
EM-9000 |
ELITE MEDICAL INC |
STEVEN J DE BROCK |
| K101333 |
05/12/2010 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
DEVONNE PAVLAK |
| K101298 |
05/10/2010 |
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS |
ENDOCHOICE, INC. |
THERON GOBER |
| K101457 |
05/26/2010 |
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K101430 |
05/21/2010 |
MLS-AC DERMA SCANNER |
ERCHONIA CORPORATION |
Kevin Walls |
| K101272 |
05/06/2010 |
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 |
ESSEX INDUSTRIES, INC. |
KEN SEISE |
| K101413 |
05/20/2010 |
EUROMI EVA SP6 |
EUROMI SA |
CURTIS RAYMOND |
| K101270 |
05/06/2010 |
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 |
EXCELSIOR MEDICAL CORP. |
NANCY RUTH |
| K101309 |
05/10/2010 |
EXELINT ALUMINUM HUB BLUNT NEEDLES |
EXELINT INTERNATIONAL CO. |
ARMAND HAMID |
| K101306 |
05/10/2010 |
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A |
FOTONA D.D. |
STOJAN TROST |
| K101387 |
05/18/2010 |
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN |
FUDAKANG INDUSTRIES CO., LTD |
STEPHEN LING |
| K101277 |
05/06/2010 |
ORION II (HEAVY DUTY 350 LBS AND 500 LBS) |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K101420 |
05/20/2010 |
GC FUJI TEMP |
GC AMERICA, INC. |
MARK HEISS |
| K101346 |
05/13/2010 |
GC ORAL MOISTURIZING GEL |
GC AMERICA, INC. |
MARK HEISS |
| K101236 |
05/03/2010 |
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM |
GE HEALTHCARE |
BRYAN BEHN |
| K101324 |
05/11/2010 |
GE ECHOPAC MODEL BT10 |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
| K101440 |
05/24/2010 |
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 |
GENERIC MEDICAL DEVICES, INC. |
JEFF MORGAN |
| K101250 |
05/04/2010 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES |
GIVEN IMAGING LTD. |
Tim Thomas |
| K101477 |
05/28/2010 |
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
WENDY MCMANUS |
| K101344 |
05/13/2010 |
G+ SYSTEM |
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) |
WILLIAM MATTHEWS |
| K101224 |
05/03/2010 |
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS |
GRIFFITHS AND NIELSEN LTD |
EDWIN LINDSAY |
| K101329 |
05/12/2010 |
SYNERGY CT PICC |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K101358 |
05/14/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K101362 |
05/14/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K101223 |
05/03/2010 |
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA |
HEIDELBERG ENGINEERING |
DIANE MANDELL-HORWITZ |
| K101242 |
05/03/2010 |
GENESIS DM MODEL: 6053000A1 |
HONEYWELL HOMMED, LLC |
EMILY HEI |
| K101438 |
05/24/2010 |
T2 GREATER TROCHANTER NAIL |
HOWMEDICA OSTEONICS CORP |
MELISSA MATARESE |
| K101435 |
05/21/2010 |
IMIX PANORAD AND SOMARAD |
IMIX ADR FINLAND OY |
DANIEL KAMM, P.E. |
| K101319 |
05/11/2010 |
IMMULISA DSDNA ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K101407 |
05/19/2010 |
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 |
IMMUNO-MYCOLOGICS, INC. |
SEAN K BAUMAN, PH.D |
| K101386 |
05/18/2010 |
VIGILANT EEG MONITOR MODEL VIGILANT 2.0 |
INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
MANAN HATHI |
| K101465 |
05/26/2010 |
STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR |
INSTITUT STRAUMANN AG |
JANET KAY |
| K101381 |
05/17/2010 |
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS |
INTEGRA LIFESCIENCES CORPORATION |
DONNA MILLISKY |
| K101279 |
05/06/2010 |
CORRIDOR4DM V2010 MODEL: V2010 |
INVIA |
DAVID ROTHKOPF |
| K101359 |
05/14/2010 |
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
| K101373 |
05/17/2010 |
EMBRACE |
IZI MEDICAL PRODUCTS INC. |
HELEN SHAFER |
| K101232 |
05/03/2010 |
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 |
JOINSOON ELECTRONICS MFG CO LTD |
JIGAR SHAH |
| K101322 |
05/11/2010 |
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 |
JOINSOON ELECTRONICS MFG CO LTD |
JIGAR SHAH |
| K101302 |
05/10/2010 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K101423 |
05/20/2010 |
OPTIBOND XTR |
KERR CORPORATION |
Wendy Garman |
| K101364 |
05/14/2010 |
LANX FACET SCREW SYSTEM |
LANX, INC. |
MICHAEL FUNK |
| K101382 |
05/17/2010 |
DPL NUVE |
LED TECHNOLOGIES, LLC |
LEWIS WARD |
| K101320 |
05/11/2010 |
VASOVAPOR |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K101241 |
05/04/2010 |
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) |
LIL DRUG STORE PRODUCTS, INC. |
PATRICIA L MILLER |
| K101263 |
05/05/2010 |
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, |
LIMA-LTO S.P.A. |
CHERYL HASTINGS |
| K101458 |
05/26/2010 |
LINA XCISE MODEL MOR-1515 |
LINA MEDICAL APS |
WALT BRITTLE |
| K101286 |
05/07/2010 |
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 |
LINDE HEALTHCARE AB |
ANDERS PALM |
| K101274 |
05/06/2010 |
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM |
MAQUET CARDIOVASCULAR, LLC |
MARK H SMITH |
| K101399 |
05/18/2010 |
COAXIAL INTRODUCER SET |
MARTECH MEDICAL PRODUCTS |
Susan Pileggi |
| K101426 |
05/21/2010 |
CEROS TCP GRANULES |
MATHYS LTD |
LINDA SCHULZ |
| K101446 |
05/24/2010 |
EMERALD SPINAL SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
JUSTIN EGGLETON |
| K101417 |
05/20/2010 |
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 |
MEDIPURPOSE PTE. LTD. |
JULIE STEPHENS |
| K101455 |
05/25/2010 |
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K101406 |
05/19/2010 |
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 |
MEDRAD INTERVENTIONAL/POSSIS |
Doug Atkins |
| K101354 |
05/14/2010 |
FETCH 2 ASPIRATION CATHETER MODEL 109400-001 |
MEDRAD INTERVENTIONAL/POSSIS |
Doug Atkins |
| K101339 |
05/12/2010 |
ARCHER SUPER STIFF GUIDEWIRES |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K101271 |
05/06/2010 |
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K101275 |
05/06/2010 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K101330 |
05/12/2010 |
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE |
MIDWEST REPROCESSING CENTER LLC |
JEROME JAMES |
| K101280 |
05/06/2010 |
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE |
MIDWEST REPROCESSING CENTER LLC |
JEROME JAMES |
| K101228 |
05/03/2010 |
MIRADA XD |
MIRADA MEDICAL LTD. |
GWILYM OWEN |
| K101403 |
05/19/2010 |
ELI 250 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHIEN HUI (AMY) YANG |
| K101363 |
05/14/2010 |
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE |
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS |
Glenn Stiegman |
| K101257 |
05/04/2010 |
ADVANCED TRAUMA DRESSING (ATD) |
NANOSYS, INC. |
HUGH DANIELS |
| K101326 |
05/11/2010 |
NMI IC |
NAVILYST MEDICAL, INC. |
NICHOLAS CONDAKES |
| K101235 |
05/03/2010 |
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM |
NEOS SURGERY S.L. |
MARCOS VELEZ-DURAN |
| K101252 |
05/04/2010 |
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
NEOTRACT, INC. |
KEVIN MACDONALD |
| K101278 |
05/06/2010 |
INERTIA PEDICLE SCREW SYSTEM |
NEXXT SPINE LLC |
KAREN WARDEN |
| K101380 |
05/17/2010 |
RXPEAKFLOW |
NOBLE MARKETING |
LAURA LYONS |
| K101312 |
05/11/2010 |
NUVUE COLORMARK9TM) NEEDLE |
NU VUE THERAPEUTICS, INC |
ROGER S KOLASINSKI |
| K101284 |
05/07/2010 |
FACET SCREW SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K101453 |
05/25/2010 |
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE |
OBI BIOLOGICS, INC. |
DUSTYN WEBB |
| K101451 |
05/25/2010 |
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K101472 |
05/27/2010 |
MULTIFIT TOTAL HIP SYSTEM |
OTIS BIOTECH CO., LTD |
SRINIVASAREDDY KROTHA |
| K101428 |
05/21/2010 |
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET |
OVESCO ENDOSCOPY AG |
ARNE BRIEST |
| K101295 |
05/10/2010 |
MROPEN |
PARAMED SRL |
RICHARD R GLASHEEN |
| K101334 |
05/12/2010 |
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
CYNDY ADAMS |
| K101221 |
05/03/2010 |
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K101474 |
05/28/2010 |
MD VISION SYSTEM |
PERKINS HEALTHCARE TECHNOLOGIES |
ANDREW C KYLE |
| K101251 |
05/04/2010 |
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
PHADIA AB |
MARTIN MANN |
| K101424 |
05/20/2010 |
PHARMACARIBE INHALED SALINE SOLUTIONS |
PHARMACARIBE |
PAUL DRYDEN |
| K101311 |
05/11/2010 |
EP NAVIGATOR R3 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K101449 |
05/24/2010 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K101342 |
05/13/2010 |
OSIRIX MD |
PIXMEO SARL |
CARL ALLETTO |
| K101262 |
05/05/2010 |
FLEXI-LITE |
PRESSURE-TECH, INC. |
MARIA GRIFFIN |
| K101225 |
05/03/2010 |
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 |
PROMIMIC AB |
KARIN BREDING |
| K101293 |
05/10/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
PT. SMART GLOVE INDONESIA |
CHO S FONG |
| K101388 |
05/17/2010 |
FASTPACK TESTO IMMUNOASSAY |
Qualigen, Inc. |
MICHAEL S POIRIER |
| K101390 |
05/17/2010 |
FASTPACK TSH IMMUNOASSAY |
Qualigen, Inc. |
MICHAEL S POIRIER |
| K101253 |
05/04/2010 |
RII INFRARED EAR THERMOMETER, MODEL: TH60N |
RADIANT INNOVATION INC. |
JAMES HUANG |
| K101350 |
05/14/2010 |
RADSCAN EQUIPMENT SLICKER |
RADSCAN MEDICAL EQUIPMENT, INC. |
ORAN R BROWN |
| K101479 |
05/28/2010 |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
REFLOW MEDICAL |
REBECCA PINE |
| K101264 |
05/05/2010 |
TEMPUS IC PROFESSIONAL PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K101233 |
05/03/2010 |
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM |
REXAM PHARMA |
JEFFREY BURRIS |
| K101299 |
05/10/2010 |
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
ANDRENE HERON |
| K101456 |
05/26/2010 |
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM |
Roche Diagnostics |
Susan Hollandbeck |
| K101365 |
05/17/2010 |
ELECSYS CA 19-9 CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
KELLY O'MAINE ADAMS |
| K101391 |
05/18/2010 |
SCANDIA-45 GAMMA CAMERA SYSTEM |
SCANDIA CORPORATION |
DAVID ASKEW |
| K101267 |
05/05/2010 |
PREMIO 10 MOXA |
SEDATELEC |
Kevin Walls |
| K101436 |
05/24/2010 |
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
SHEN WEI (USA), INC. |
ABLERT LI |
| K101343 |
05/12/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
CHU XIAOAN |
| K101341 |
05/12/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD |
CHU XIAOAN |
| K101460 |
05/26/2010 |
LOCI 8 CALIBRATOR, MODEL KC 646 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE ENNIS |
| K101425 |
05/20/2010 |
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES |
SIEMENS HEALTHCARE DIAGNOSTICS |
Elisabeth Warriner |
| K101347 |
05/13/2010 |
MAGNETOM AERA; MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
KIM RENDON |
| K101459 |
05/26/2010 |
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 |
SMITH & NEPHEW, INC. |
JULIE ACKER |
| K101377 |
05/17/2010 |
SMITH & NEWPHEW ULTRABRAID II SUTURE |
SMITH & NEWPHEW, INC |
CHRISTINA FLORES |
| K101337 |
05/12/2010 |
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K101288 |
05/07/2010 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K101328 |
05/11/2010 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K101419 |
05/20/2010 |
ENSITE VELOCITY SYSTEM, MODEL EE3000 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K101239 |
05/03/2010 |
VIEWFLEX PLUS ICE CATHETER |
ST. JUDE MEDICAL |
LOUCINDA BJORKLUND |
| K101409 |
05/19/2010 |
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K101335 |
05/12/2010 |
CELL-CHEX |
Streck |
KERRIE OETTER |
| K101444 |
05/24/2010 |
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO |
FRANK GIANELLI |
| K101378 |
05/17/2010 |
FRANKENMAN SURGICAL STAPLERS |
SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. |
JEAN ASQUITH |
| K101321 |
05/11/2010 |
EMATRIX CO2 |
SYNERON MEDICAL LTD. |
AVI HIRSHNZON |
| K101259 |
05/04/2010 |
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K101338 |
05/12/2010 |
NEWFIX EXTERNAL FIXATION SYSTEM |
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
ROBERT BARD |
| K101401 |
05/18/2010 |
NEUMOVENT GRAPHNET MODEL 3179L1V |
TECME S.A. |
RAYMOND KELLY |
| K101254 |
05/04/2010 |
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
ROBERT J BARD, JD |
| K101356 |
05/14/2010 |
SPACER-K, SPACER-G, SPACER-S |
TECRES SPA |
CHRISTINE BRAUER |
| K101287 |
05/07/2010 |
TEPHAFLEX COMPOSITE MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K101310 |
05/11/2010 |
VU APOD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
Glenn Stiegman |
| K101415 |
05/20/2010 |
THERACLEAR |
THERAVANT CORPORATION |
Marcy Moore |
| K101375 |
05/17/2010 |
TRIMED X-FIX |
TRIMED, INC. |
KELLI ANDERSON |
| K101244 |
05/04/2010 |
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE |
TRUER MEDICAL INC. |
TIM TRUITT |
| K101353 |
05/14/2010 |
GOLDEN GATE ANTERIOR PLATE SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K101245 |
05/04/2010 |
ULTRASEAL ID |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K101412 |
05/20/2010 |
EVA TPN BAG |
VALMED S.R.L. |
WALTER SVANOSIO |
| K101294 |
05/10/2010 |
PT2 VARIAN PROTON THERAPY SYSTEM |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K101234 |
05/03/2010 |
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
Judy Howe |
| K101445 |
05/24/2010 |
VITAL SIGNS MONITOR-VSM 6000 SERIES |
WELCH ALLYN, INC. |
HY DOAN |
| K101471 |
05/27/2010 |
AXLE INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K101227 |
05/03/2010 |
BACK-TEK |
YORK BIOMEDICAL INC |
Calley Herzog |
| K101229 |
05/03/2010 |
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER |
ZIMMER, INC. |
REBECCA BROOKS |
| K101296 |
05/10/2010 |
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS |
ZIMMER, INC. |
CHRISTINA FORNEY |
