| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080466 |
10/21/2008 |
ALCOHOL PAD |
122 CORPORATION |
DONALD CANAL |
| K073645 |
10/21/2008 |
SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM |
659543 BC LTD. |
HAROLD BERGMAN |
| K082717 |
10/30/2008 |
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K082032 |
10/06/2008 |
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) |
ABBOTT SPINE, INC. |
DAVID PADGETT |
| K081127 |
10/17/2008 |
ACCIN TOTAL KNEE SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K082071 |
10/02/2008 |
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT |
ADPHARMA, INC. |
VIVEK RAMANA |
| K081545 |
10/02/2008 |
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 |
ADVANCED MEDICAL OPTICS, INC. |
KIM REGIS |
| K081681 |
10/08/2008 |
VITRECTOMY CUTTER AND ACCESSORIES |
ADVANCED MEDICAL OPTICS, INC. |
Evelyn De La Vega |
| K081650 |
10/23/2008 |
AERONEB GO NEBULIZER |
AEROGEN (IRELAND) LTD |
FRANK ENRIGHT |
| K082232 |
10/15/2008 |
EVIS MD PLANTIUM BLUE |
AGELESS BEAUTY CORPORATION |
JILL CREASY |
| K082247 |
10/08/2008 |
EVIS MD PLATINUM RED LIGHT THERAPY |
AGELESS BEAUTY CORPORATION |
JILL CREASY |
| K080348 |
10/09/2008 |
OXISCAN II DATA MANAGEMENT SYSTEM |
AIRSEP CORP. |
PETER WEISERBORN |
| K081935 |
10/07/2008 |
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 |
AKTINA MEDICAL PHYSICS CORP. |
TONY SPACCAROTELLA |
| K081710 |
10/15/2008 |
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE |
AMERICAN MEDICAL SYSTEMS |
DENISE THOMPSON |
| K082006 |
10/20/2008 |
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS |
AMERICAN MEDICAL SYSTEMS, INC. |
STEPHANIE GEORGE |
| K082831 |
10/23/2008 |
AMSELF CLOSED CATHETERIZATION SYSTEM |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K080851 |
10/10/2008 |
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY |
ANTICANCER INC |
YUYING TAN |
| K080254 |
10/31/2008 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
JEFF RYBERG |
| K081724 |
10/30/2008 |
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL |
APPLIED NUTRITIONALS |
ANITA PETITO |
| K082839 |
10/24/2008 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
BRYAN BABB |
| K081312 |
10/31/2008 |
ARAGON ONESHOT SYSTEM |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K082217 |
10/06/2008 |
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K082417 |
10/21/2008 |
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 |
ARKRAY Factory USA, Inc. |
TOM SPEIKERS |
| K082666 |
10/15/2008 |
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K081893 |
10/01/2008 |
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 |
ARTHROCARE CORP. |
LAURA KASPEROWICZ |
| K082515 |
10/03/2008 |
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX |
ASAHI KASEI MEDICAL CO., LTD. |
DAVID L WEST |
| K082174 |
10/20/2008 |
Y-ADAPTER |
ASTHMATX, INC. |
CARTER NAVARRO |
| K081666 |
10/07/2008 |
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS |
ASTRA TECH, INC. |
BETSY A BROWN |
| K081880 |
10/02/2008 |
ATLAS SPINE SPACER |
ATLAS SPINE INC. |
JEANNETTE G DAILEY |
| K081820 |
10/06/2008 |
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR |
AVALON LABORATORIES, LLC |
DAVID C FURR |
| K081933 |
10/03/2008 |
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR |
AVALON LABORATORIES, LLC |
LEE WIRTH |
| K082199 |
10/17/2008 |
SPIRALFUSE PERIPHERAL INFUSION SYSTEM |
BACCHUS VASCULAR, INC. |
BOB MCRAE |
| K082202 |
10/08/2008 |
HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K082944 |
10/16/2008 |
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM |
BAUSCH & LOMB, INC. |
DAVID THOMAS |
| K081717 |
10/10/2008 |
TRICOS A RESORBABLE BONE SUBSTITUTE |
BAXTER HEALTHCARE CORP. |
VALERIE FOLLOWELL |
| K082486 |
10/08/2008 |
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE |
BAYER HEALTHCARE, LLC |
ROGER SONNENBURG |
| K082271 |
10/06/2008 |
FLUCONAZOLE 25UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
JANINE MATLAK |
| K082272 |
10/02/2008 |
VORICONAZOLE 1UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
JANINE MATLAK |
| K083066 |
10/30/2008 |
CHROMOPHARE E 778 AND E 558 |
BERCHTOLD HOLDING GMBH |
SILKE GORAL |
| K073368 |
10/10/2008 |
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT |
BICON, LLC |
VINCENT J MORGAN |
| K080003 |
10/23/2008 |
BINAXNOW G6PD TEST |
BINAX, INC. |
Anne Jepson |
| K073307 |
10/29/2008 |
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM |
BIO-TECHNOLOGY USA, INC. |
IAN GORDON |
| K082263 |
10/24/2008 |
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K082564 |
10/20/2008 |
HYPERQ SYSTEM |
BIOLOGICAL SIGNAL PROCESSING, LTD. |
GEORGE J HATTUB |
| K080194 |
10/09/2008 |
VIDAS CEA (S) ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080979 |
10/31/2008 |
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT |
BIOMET MANUFACTURING CORP. |
GARY BAKER |
| K082826 |
10/24/2008 |
VANGUARD CR STEM HOUSINGS |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
| K081952 |
10/07/2008 |
SYNERGY SPINAL SYSTEM (6.35 POLARIS) |
BIOMET SPINE |
VIVIAN KELLY |
| K082446 |
10/15/2008 |
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS |
BIOMET, INC. |
BECKY EARL |
| K081478 |
10/06/2008 |
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K082757 |
10/01/2008 |
MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
| K082797 |
10/17/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K082906 |
10/30/2008 |
UNITY BETA ANCHOR SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK G BALSMANN |
| K081733 |
10/27/2008 |
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 |
BOSTON SCIENTIFIC CORP. |
WING NG |
| K082928 |
10/16/2008 |
STRAIGHT FIRE HOLMIUM LASER FIBER |
BOSTON SCIENTIFIC CORP. |
LAUREN B ANDERSON |
| K082109 |
10/02/2008 |
BOVIE ICON GENERAL PURPOSE RF GENERATOR |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K081187 |
10/08/2008 |
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 |
BRIDGEPOINT MEDICAL |
MICHAEL A DANIEL |
| K082687 |
10/17/2008 |
COLLAMEND FM IMPLANT |
C.R. BARD, INC. |
KEVIN G STEVENS |
| K082305 |
10/31/2008 |
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K082681 |
10/15/2008 |
VACORA VACUUM ASSISTED BIOPSY SYSTEM |
C.R. BARD, INC. |
CINDY MOSS |
| K080944 |
10/23/2008 |
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER |
C.R. BARD, INC. |
TERRI MORRIS |
| K082260 |
10/17/2008 |
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES |
CALVARY SPINE LLC |
J.D. WEBB |
| K081670 |
10/09/2008 |
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
CARDINAL HEALTH 207, INC. |
ANDRE VON MULLER |
| K082981 |
10/31/2008 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT |
CARDIOVASCULAR SYSTEMS, INC. |
DAVID D BROOKE |
| K080906 |
10/17/2008 |
CDB CLIP |
CDB CORPORATION |
JENS RUMSFELD |
| K073022 |
10/01/2008 |
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 |
CLAREBLEND, INC. |
JILL CREASY |
| K073000 |
10/01/2008 |
LUMAPROBE |
CLAREBLEND, INC. |
JILL CREASY |
| K080632 |
10/15/2008 |
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS |
CLEARLAB SG PTE LTD. |
MARTIN DALSING |
| K082599 |
10/17/2008 |
NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT |
CNSYSTEM MEDIZINTECHNIK AG |
SUMPER |
| K082640 |
10/17/2008 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM |
COLOPLAST MANUFACTURING US, LLC |
ANGELA BYLAND |
| K081178 |
10/09/2008 |
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
MARTIN DALSING |
| K082058 |
10/02/2008 |
DYNAMATRIX |
COOK BIOTECH, INC. |
DAVID J COLLETTE |
| K082536 |
10/27/2008 |
COOK WIRE GUIDES |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K082051 |
10/16/2008 |
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 |
COSMAN MEDICAL, INC. |
LOUIS FALCONE |
| K082012 |
10/14/2008 |
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN |
COSMAN MEDICAL, INC. |
LOUIS FALCONE |
| K082966 |
10/31/2008 |
PB 540 VENTILATOR |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
TINA O'BRIEN |
| K082258 |
10/16/2008 |
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR |
CROSSTEX INTERNATIONAL |
RICHARD M ORMSBEE |
| K081413 |
10/24/2008 |
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM |
DAILIAN LATEX COMPANY, LTD. |
|
| K082241 |
10/30/2008 |
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 |
DALE MEDICAL PRODUCTS, INC. |
ROSINA ROBINSON |
| K082784 |
10/07/2008 |
JUMAO MANUAL WHEELCHAIR |
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. |
QING WANG |
| K072752 |
10/31/2008 |
BP LIMBO XL, BPTANGO XL, BP SALSA XL |
DATADANCER MEDICAL SYSTEMS |
MICHAEL KOHUT |
| K081842 |
10/03/2008 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA, INC. |
ADRIENNE LENZ |
| K081010 |
10/07/2008 |
BARD 3DMAX MESH |
DAVOL INC., SUB. C.R. BARD, INC. |
STEPHANIE BAKER |
| K073582 |
10/15/2008 |
VRIICU SYSTEM |
DEEP BREEZE LTD. |
JEFF BAETZ |
| K082198 |
10/29/2008 |
DURASHIELD PLUS |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K082942 |
10/31/2008 |
MODFICATION TO: EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K082675 |
10/10/2008 |
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K081447 |
10/08/2008 |
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO |
DRAEGER MEDICAL AG & CO. KG |
KARIN LUEBBERS |
| K080559 |
10/09/2008 |
DIO SM IMPLANT SYSTEM |
DSI, INC. |
HYUNGICK KIM |
| K081382 |
10/23/2008 |
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K082410 |
10/31/2008 |
MASTER3DS |
E-WOO TECHNOLOGY |
CHARLIE MACK |
| K081385 |
10/09/2008 |
URESTA PESSARY |
EASTMED INC. |
SHIRLEY FURESZ |
| K082139 |
10/23/2008 |
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 |
EDWARDS LIFESCIENCES, LLC. |
DARYL RICHARDSON |
| K082663 |
10/06/2008 |
COLOR LCD MONITOR |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K082106 |
10/02/2008 |
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) |
ELCAM MEDICAL A.C.A.L. |
TALI HAZAN |
| K072603 |
10/23/2008 |
ABC SYRINGE INFUSION PUMP, MODEL 4100 |
ELIXIR CORPORATION |
WILLIAM M VONDERSMITH |
| K081408 |
10/17/2008 |
ELLIPSE MULTIFLEX |
ELLIPSE A/S |
OLE KOFOD |
| K082601 |
10/09/2008 |
UltraClot, UltraClot OTC |
EMERGENCY MEDICAL DEVICES, LLC |
JACK MENTKOW |
| K082398 |
10/15/2008 |
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K082420 |
10/08/2008 |
TRACHEOSCOPIC VENTILATION TUBE (TVT) |
ETVIEW |
YORAM LEVY |
| K082702 |
10/10/2008 |
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY |
EXACTECH, INC. |
SHING JEN TAI |
| K081741 |
10/31/2008 |
NEUROLINK IP, MODEL PK1113 |
EXCEL-TECH LTD. (XLTEK) |
GOLDY SINGH |
| K080793 |
10/16/2008 |
FIRMGRIP |
FLEXICATH LTD. |
TALI HAZAN |
| K082163 |
10/29/2008 |
FLOWMEDICA BENEPHIT INFUSION SYSTEMS |
FLOWMEDICA, INC. |
JEFF ELKINS |
| K082414 |
10/28/2008 |
OPTIFLUX F250NR, MODEL 0500325E |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K082092 |
10/15/2008 |
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE |
GALEMED CORP. |
THOMAS LOESCHER |
| K082171 |
10/30/2008 |
GRADIA CORE |
GC AMERICA, INC |
MARK HEISS |
| K082768 |
10/21/2008 |
G-BOND PLUS |
GC AMERICA, INC. |
MARK HEISS |
| K082816 |
10/08/2008 |
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
STEVEN KACHELMEYER |
| K082761 |
10/08/2008 |
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
TRACEY ORTIZ |
| K082960 |
10/17/2008 |
GE XTREME INJECTOR OPTION |
GE MEDICAL SYSTEMS, LLC |
STEVEN KACHELMEYER |
| K082442 |
10/07/2008 |
MODIFICATION TO MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K082865 |
10/23/2008 |
MODIFICATION TO ZENIEVA |
GORBEC PHARMACEUTICAL SERVICES, INC. |
SANDRA R KIRCUS |
| K082298 |
10/23/2008 |
FLASH N' GO |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K073309 |
10/17/2008 |
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT |
HORIBA ABX |
OLIVIER DUCAMP |
| K083019 |
10/22/2008 |
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE |
HOSPIRA, INC. |
Yuliya Matlin |
| K082567 |
10/03/2008 |
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K082018 |
10/10/2008 |
T2 FLEXIBLE NAIL |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
| K081572 |
10/01/2008 |
SMARTSIGNS MINPULSE |
HUNTLEIGH HEALTHCARE LTD. |
ROBERT MCCARTHY |
| K080923 |
10/17/2008 |
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB |
i-SENS, Inc. |
HYUN JOON OH |
| K080275 |
10/09/2008 |
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
IASIS MEDICAL, INC. |
JOHN BUAN |
| K080909 |
10/17/2008 |
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 |
IKONISYS INC |
SYED ATAULLAH |
| K082402 |
10/16/2008 |
OSDX HIP BMD SYSTEM |
IMAGING THERAPEUTICS, INC. |
PATRICK HESS |
| K080825 |
10/03/2008 |
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 |
IMPEDIMED PTY LTD. |
PHILIP S AUCKLAND |
| K080908 |
10/17/2008 |
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM |
INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION |
JENNIFER SPINELLA |
| K081248 |
10/27/2008 |
QUANTA LITE OMP PLUS ELISA |
INOVA DIAGNOSTICS, INC. |
ZAKERA SHUMS |
| K082545 |
10/17/2008 |
STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K082764 |
10/01/2008 |
STRAUMANN WN CARES TITANIUM ABUTMENT |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K081401 |
10/08/2008 |
MAYFIELD MR/X-RAY SKULL CLAMP |
INTEGRA LIFESCIENCES CORP. |
HELDER A SOUSA |
| K082250 |
10/10/2008 |
AURAGEN CORTICAL SURFACE ELECTRODES |
INTEGRA NEUROSCIENCES |
JON CAPAROTTA |
| K081436 |
10/22/2008 |
INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES |
INVIRO MEDICAL DEVICES, INC. |
ROBERT N CLARK |
| K082916 |
10/15/2008 |
HRB-127-32 HIGH RESOLUTION BRAIN COIL |
INVIVO |
JEFF WILKINSON |
| K082530 |
10/30/2008 |
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY |
ISODOSE CONTROL B.V. |
HUB VAN DE BERGH |
| K081107 |
10/10/2008 |
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS |
K2M, INC. |
RICHARD W WOODS |
| K082046 |
10/10/2008 |
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MONIKA CAMPBELL |
| K082767 |
10/21/2008 |
KOWA NONMYD ALPHA-DIII |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K081587 |
10/24/2008 |
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 |
KRELL PRECISION (YANG ZHOU) CO., LTD. |
CHARLIE MACK |
| K082900 |
10/28/2008 |
KYMCO FORU, MODEL EQ10 |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K082901 |
10/28/2008 |
KYMCO FORU, MODEL EQ20 |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K082338 |
10/16/2008 |
POLYBONE GRANULE & BLOCK |
KYUNGWON MEDICAL CO., LTD. |
JUNG BAE BANG |
| K082774 |
10/21/2008 |
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
LANX, LLC |
Alan Burkholder |
| K082592 |
10/08/2008 |
LDR SPINE EASYSPINE SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K082802 |
10/09/2008 |
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B |
LEARNING CURVE BRANDS INC. THE FIRST YEARS |
SUPRAVAN KHONGKRUAPHAN |
| K083017 |
10/24/2008 |
LEVO C3 |
LEVO AG |
THOMAS RABER |
| K082923 |
10/24/2008 |
PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C |
LIFE-TECH, INC. |
JEFF KASOFF |
| K082103 |
10/08/2008 |
LTM WOUND DRESSING |
LIFECELL CORP. |
MANAL MORCOS |
| K081438 |
10/17/2008 |
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT |
LifeNet Health |
ALYCE LINTHURST JONES |
| K082513 |
10/22/2008 |
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
Oyinkan Donaldson |
| K072926 |
10/15/2008 |
HELONTIX VENT |
LINDE GAS THERAPEUTICS |
ANN-CATHRIN JAREMAN |
| K080901 |
10/02/2008 |
LBI EMBOLECTOMY SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| K082096 |
10/08/2008 |
POWERLIPO LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K081884 |
10/08/2008 |
MAJOR.BASE 20 |
MAJOR PRODOTTI DENTARI S.P.A. |
MONICA FUNAI |
| K082088 |
10/22/2008 |
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K082081 |
10/15/2008 |
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K082237 |
10/09/2008 |
PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST |
MALLINCKRODT DEVELOPPEMENT FRANCE |
TINA DREILING |
| K082520 |
10/02/2008 |
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES |
MALLINCKRODT MEDICAL |
SCOTT D DICKERHOFF |
| K082544 |
10/03/2008 |
QUART ARTERIAL FILTER WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K082703 |
10/14/2008 |
MRDH BANDAGE |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K082052 |
10/10/2008 |
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K082856 |
10/15/2008 |
CARAPASTE ORAL WOUND DRESSING |
MCGRATH PHARMACEUTICALS, INC. |
PATRICK D MCGRATH |
| K081023 |
10/22/2008 |
EVOLIS TOTAL KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K082587 |
10/02/2008 |
AUTO-SAFETY INJECTOR-2 (ASI-2) |
MEDICAL HOUSE PRODUCTS LIMITED |
ROSE Y GUANG |
| K082969 |
10/23/2008 |
LUMINEX INFRARED LAMP SYSTEM |
MEDICAL LASER SYSTEMS INC |
MIKI KOLTON |
| K082798 |
10/28/2008 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 |
MEDICATECH USA |
DANIEL KAMM |
| K082069 |
10/03/2008 |
PASS 2 SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K082577 |
10/03/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J D WEBB |
| K082514 |
10/21/2008 |
TENS/EMS COMBO, EMS, TENS |
MEDIHIGHTEC MEDICAL CO., LTD. |
MU-SHENG HUNG |
| K082657 |
10/08/2008 |
RTX RESPIRATOR |
MEDIVENT LIMITED |
SHAHAR HAYEK |
| K081594 |
10/17/2008 |
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K082458 |
10/17/2008 |
P3T ABDOMEN |
MEDRAD, INC. |
FORTUNATO ALDAPE |
| K080339 |
10/27/2008 |
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) |
MEDSOURCE INTERNATIONAL, LLC. |
HOWARD T COOPER |
| K082464 |
10/27/2008 |
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 |
MEDTRONIC INC. |
JEANMARIE SALES |
| K082236 |
10/10/2008 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
BRAD SHEALS |
| K082732 |
10/16/2008 |
MODIFICATION TO: CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K081475 |
10/17/2008 |
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
| K082707 |
10/01/2008 |
MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K081791 |
10/21/2008 |
E-Z CLEAN ELECTROSURGICAL ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K082149 |
10/06/2008 |
LYMPHA PRESS OPTIMAL, MODEL# 1201AP |
MEGO AFEK AC LTD |
AHAVA STEIN |
| K082063 |
10/15/2008 |
PRELUDE SHORT SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
JERRIE HENDRICKSON |
| K082357 |
10/29/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K080786 |
10/03/2008 |
ML830TP |
MICROLIGHT CORPORATION OF AMERICA |
FRED A SIMPSON |
| K082461 |
10/02/2008 |
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K082739 |
10/17/2008 |
MICRUS MICROCOIL DELIVERY SYSTEM |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K081965 |
10/27/2008 |
MPOWRX SNORING SOLUTION |
MPOWRX HEALTH AND WELLNESS PRODUCTS INC. |
JEAN ASQUITH |
| K080399 |
10/10/2008 |
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY B JOY |
| K082493 |
10/23/2008 |
MEDICAL DISPLAY, MD205MG-1 |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
| K082238 |
10/01/2008 |
NEOMED POLYURETHANE FEEDING TUBE |
NEOMED, INC. |
PENNY NORTHCUTT |
| DEN070003 |
10/07/2008 |
NEUROSTAR TMS SYSTEM |
NEURONETICS |
JUDY P WAYS |
| K082336 |
10/15/2008 |
XR-EXPRESS |
NEW MEXICO SOFTWARE, INC. |
NEAL KOLBER |
| K071969 |
10/06/2008 |
SEN-4100 ELECTRIC STIMULATOR |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K081210 |
10/21/2008 |
NIPRO SAFETOUCH HUBER INFUSTION SET |
NIPRO MEDICAL CORP. |
JESSICA OSWALD |
| K080057 |
10/31/2008 |
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL |
NOVX SYSTEMS INC. |
THOMAS TSAKERIS |
| K082868 |
10/24/2008 |
MULLINS-X, MODEL 250X |
NUMED, INC. |
NICHELLE LAFLESH |
| K081611 |
10/02/2008 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K082332 |
10/10/2008 |
NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K080919 |
10/15/2008 |
NXSTAGE PUREFLOW SL |
NXSTAGE MEDICAL, INC. |
MICHAEL DOYLE |
| K080581 |
10/16/2008 |
VB IMAGE VIEWER |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K082576 |
10/21/2008 |
XCHF-T160 VIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K081654 |
10/10/2008 |
HEM-9000AI |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K082812 |
10/22/2008 |
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K081900 |
10/24/2008 |
TEMPORARY TOOTH REPLACEMENT |
ORMCO CORP. |
Wendy Garman |
| K082445 |
10/15/2008 |
CURATIVE980 DIODE LASER |
OROSCIENCE, INC. |
PHIL HOULE |
| K081543 |
10/23/2008 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
LEAH VAN DE WATER |
| K082945 |
10/31/2008 |
STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
ALAN T SANDIFER |
| K082375 |
10/17/2008 |
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K082213 |
10/14/2008 |
GS III FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K082615 |
10/16/2008 |
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES |
OSTEOTECH INC |
CHRIS TALBOT |
| K082242 |
10/08/2008 |
ICON, MODEL C3 |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
| K082314 |
10/28/2008 |
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR |
OTTO BOCK HEALTH CARE, LP |
WILLIAM JACKSON |
| K082722 |
10/28/2008 |
P & F POWER WHEELCHAIR, MODEL HC-500SB |
P&F BROTHER IND.,CORP |
Ke-Min Jen |
| K082164 |
10/27/2008 |
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
| K082183 |
10/28/2008 |
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G. H. QUASS |
| K082664 |
10/06/2008 |
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
KEN PERINO |
| K082290 |
10/31/2008 |
NEURON DELIVERY CATHETER 070 |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K082280 |
10/08/2008 |
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
MARY KRUITWAGEN |
| K081793 |
10/14/2008 |
PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K082633 |
10/03/2008 |
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K082721 |
10/28/2008 |
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS |
PHOTOMEDEX, INC. |
ALFRED INTINTOLI |
| K081053 |
10/09/2008 |
PIVOT ASSIST |
PIVOT ASSIST, LLC |
JOHN QUIGLEY |
| K082301 |
10/06/2008 |
GRIND NO MORE |
PLACONTROL INC. |
JONATHAN S KAHAN |
| K072348 |
10/27/2008 |
PRECISION OXYGEN CONCENTRATOR |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K082330 |
10/09/2008 |
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
PRIMARY CARE SOLUTIONS, INC. |
RON MADDIX |
| K082661 |
10/06/2008 |
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K080629 |
10/20/2008 |
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS |
PROMEDICAL PRODUCTS CO., LTD. |
LEO WEI |
| K082221 |
10/22/2008 |
RAYDOSE |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K082718 |
10/10/2008 |
TEMPUSIC PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K081321 |
10/09/2008 |
MODIFICATION TO MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K082447 |
10/14/2008 |
DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082595 |
10/28/2008 |
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
Roche Diagnostics |
Scott Thiel |
| K073522 |
10/10/2008 |
VITRIFICATION KIT & VITRIFICATION WARMING KIT |
SAGE IN-VITRO FERTILIZATION INC. |
GRACE HOLLAND |
| K081352 |
10/23/2008 |
PROFILE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K083043 |
10/27/2008 |
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
DACHENG GONG |
| K083001 |
10/22/2008 |
M5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TAN CHUANBIN |
| K081732 |
10/24/2008 |
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN A DRAY-LYONS |
| K082680 |
10/10/2008 |
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K081857 |
10/30/2008 |
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 |
Siemens Healthcare Diagnostics Inc. |
GEORGE M PLUMMER |
| K082220 |
10/10/2008 |
SOMATOM FLASH DS |
SIEMENS MEDICAL SOLUTIONS USA INC. |
CORRINE MCLEOD |
| K082331 |
10/01/2008 |
MAGNETOM C! |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K082370 |
10/17/2008 |
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K082095 |
10/21/2008 |
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHY REDDIG |
| K082267 |
10/29/2008 |
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K082543 |
10/14/2008 |
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 |
SONOCINE, INC. |
ROBERT J CHIN |
| K081832 |
10/10/2008 |
ENSPLINTCMX CLAVICLE PIN |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CHARLES NELSON |
| K083021 |
10/29/2008 |
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K081404 |
10/21/2008 |
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT |
SPINAL INTEGRATION LLC |
TRUDIE L SEEGER |
| K081196 |
10/16/2008 |
SPINAL USA VBR SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K082821 |
10/31/2008 |
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM |
SPINE SMITH PARTNERS L.P. |
ROBERT JONES |
| K073700 |
10/02/2008 |
6F PROXIS SYSTEM |
ST. JUDE MEDICAL, INC. |
LINH PHAM |
| K082017 |
10/10/2008 |
STARR FRAME STEINMANN PIN |
STARR FRAME LLC |
FRANK GEROME |
| K082532 |
10/21/2008 |
STRAUMANN GUIDED INSTRUMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K080052 |
10/02/2008 |
STRYKER ESSX WITH NAVIGATION MOUNT |
STRYKER CORP. |
VALERIE FRANCK |
| K081995 |
10/02/2008 |
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) |
Stryker Endoscopy |
MONICA BARRETT |
| K082608 |
10/07/2008 |
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 |
STRYKER SPINE |
CURTIS TRUESDALE |
| K082209 |
10/28/2008 |
DEVILBISS DV5M SMARTLINK SYSTEM |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K080854 |
10/20/2008 |
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 |
SUNTECH MEDICAL, INC. |
DAVID GALLIK |
| K082828 |
10/14/2008 |
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE |
SUTURTEK INCORPORATED |
ART RANKIS |
| K081890 |
10/10/2008 |
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER |
SYSMEX AMERICA, INC. |
CARRIE PINEDA |
| K082618 |
10/07/2008 |
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080347 |
10/09/2008 |
UNISCAN -DOA SYSTEM |
TAIWAN UNISON BIOTECH, INC. |
KUANG-PIN HSIUNG |
| K082597 |
10/24/2008 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K082178 |
10/30/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
MARY P LEGRAW |
| K082820 |
10/23/2008 |
K-PACK II NEEDLE - 29G THIN WALL |
TERUMO EUROPE N.V. |
M J AERTS |
| K082847 |
10/29/2008 |
PINNACLE ROII INTRODUCER SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K081674 |
10/15/2008 |
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K082311 |
10/08/2008 |
EXSUDEX WOUND DRAINAGE PUMP |
THE MEDICAL COMPANY |
HARM JAAP SMIT |
| K083135 |
10/31/2008 |
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 |
THERMOGEAR, INC. |
WAYNE FIELDS, PHD |
| K082510 |
10/01/2008 |
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K082120 |
10/24/2008 |
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS |
TORNIER |
DAMIEN GUILLAUD |
| K082684 |
10/14/2008 |
4D VIEWER RADIOLOGY, MODEL USWP-100A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083014 |
10/17/2008 |
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082830 |
10/10/2008 |
INFX-8000H, INFINIX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
| K080527 |
10/31/2008 |
TWINGUARD WITH CAPNOGRAPH ACCESSORY |
TRAWAX PTY LIMITED |
CINDY MARTIN |
| K081520 |
10/24/2008 |
SENSITITRE VIZION |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K082135 |
10/21/2008 |
SHOWCASE |
TRILLIUM TECHNOLOGY, INC |
GARY J ALLSEBROOK |
| K081348 |
10/17/2008 |
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD |
TRIMED, INC. |
KELLI ANDERSON |
| K082954 |
10/17/2008 |
ENCAGE BIPOLAR RF PROBE |
TROD MEDICAL SA |
CELINE GARCIA |
| K082919 |
10/27/2008 |
UC-CARE POSITIONING SYSTEM |
UC-CARE MEDICAL SYSTEMS LTD |
JONATHAN S KAHAN |
| K083095 |
10/31/2008 |
SONIXTOUCH ULTRASOUND SYSTEM |
UltraSonix Medical Corporation |
CHAS YU |
| K080877 |
10/21/2008 |
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 |
UNILIFE MEDICAL SOLUTIONS LIMITED |
MICHELLE GOW |
| K082959 |
10/10/2008 |
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS |
UNIMED MEDICAL SUPPLIES INC. |
LIMING XUE |
| K082653 |
10/10/2008 |
CENTERING INTRALUMINAL APPLICATOR |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K082870 |
10/28/2008 |
VTI INTRAOPERATIVE DOPPLER SYSTEMS |
VASCULAR TECHNOLOGY INCORPORATED |
DAVID L REGAN |
| K081626 |
10/15/2008 |
FLOWPICC CONSOLE |
VASONOVA INC. |
SORIN GRUNWALD |
| K082350 |
10/10/2008 |
PAX-500 |
VATECH CO., LTD. |
DAVE KIM |
| K082667 |
10/30/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K081997 |
10/09/2008 |
PERFADEX WITH THAM |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K082890 |
10/15/2008 |
VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2 |
VNUS MEDICAL TECHNOLOGIES, INC. |
ELIZABETH TRUJILLO |
| K082285 |
10/24/2008 |
EASY GLAZE |
VOCO GMBH |
THORSTEN GERKENSMEIER |
| K082229 |
10/08/2008 |
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM |
VOLCANO CORPORATION |
MAMTA VATS |
| K081799 |
10/03/2008 |
GORE TRI-LOBE BALLOON CATHETER |
W. L. GORE & ASSOCIATES, INC. |
KANU H VADODARIA |
| K082815 |
10/08/2008 |
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS |
WELL LEAD MEDICAL INSTRUMENTS |
HAN GUANG YUAN |
| K082158 |
10/15/2008 |
DENSEO FAIRY |
XPDENT CORP |
CARMEN PEREZ |
| K082822 |
10/22/2008 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO ZHUANGYUAN PLASTIC PRODUCTS COMPANY |
CHU XIAOAN |
| K081759 |
10/16/2008 |
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V |
ZIMMER GMBH |
ERIC S PITTMAN |
| K082326 |
10/08/2008 |
ZONARE ULTRA ULTRASOUND SYSTEM |
ZONARE MEDICAL SYSTEMS, INC. |
LINDA J MOORE |
