| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080513 |
01/30/2009 |
QLASER SYSTEM |
2035, INC. |
Kevin Walls |
| K093169 |
11/12/2009 |
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) |
A PLUS INTERNATIONAL, INC. |
SOLOMON CHEN |
| K092687 |
11/23/2009 |
VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER |
A PLUS MEDICAL |
THOMAS LOESCHER |
| K082716 |
01/15/2009 |
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 |
A-DEC, INC. |
THOMAS H LOUISELL |
| K082827 |
01/07/2009 |
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT |
A-DEC, INC. |
THOMAS H LOUISELL |
| K082534 |
11/02/2009 |
ETEST VORICONAZOLE 0.002-32 UG/ML |
AB BIOMERIEUX |
ANETTE ENGELHARDT |
| K083574 |
01/29/2009 |
RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
KERI YEN |
| K090730 |
11/13/2009 |
AKITA JET |
ACTIVAERO AMERICA, INC. |
PAUL DRYDEN |
| K082668 |
01/23/2009 |
BIO-SCREEN |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K082887 |
01/16/2009 |
PM-1000F+PATIENT MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLIAN |
| K083915 |
01/29/2009 |
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC |
ADVANCED TECHNOLOGY LASER CO., LTD. |
Diana Hong |
| K092503 |
11/19/2009 |
RADAR VASCULAR COMPRESSION DEVICES |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K092166 |
11/23/2009 |
S. AUREUS/CNS PNA FISH, MODEL KT005 |
ADVANDX, INC. |
PAULA E BULGER |
| K083495 |
01/15/2009 |
MODIFICATION TO: METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K083730 |
01/09/2009 |
ISOLAZ |
AESTHERA CORPORATION |
PAMELA M BUCKMAN |
| K083279 |
01/28/2009 |
CALTRIX RESORBABLE BONE VOID FILLER |
AG DIGITAL TECHNOLOGY CORP. |
JENNIFER REICH |
| K092669 |
11/06/2009 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
JEFFERY A JEDLICKA |
| K090061 |
01/23/2009 |
AIRSTRIP OB |
AIRSTRIP TECHNOLOGIES, LP |
|
| K083040 |
01/30/2009 |
S-TEST C-REACTIVE PROTEIN (CRP) |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DENNIS TASCHEK |
| K083826 |
01/22/2009 |
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K082622 |
01/12/2009 |
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE |
ALMA LASERS LTD. |
ANNE WORDEN |
| K093488 |
11/20/2009 |
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K082857 |
01/06/2009 |
RENEGADE WHEELCHAIR |
ALPHA ONE |
PATSY J TRISLER |
| K083496 |
01/30/2009 |
CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS |
ALTATEC GMBH |
LINDA K SCHULZ |
| K092568 |
11/17/2009 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
RICHARD JANSEN |
| K092826 |
11/12/2009 |
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL |
AMERICAN BIOTECH LABS |
MIRIAM PROVOST |
| K092735 |
11/09/2009 |
GREENLIGHT XPS LASER SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
DARLENE-CROCKET BILLIG |
| K081767 |
01/09/2009 |
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 |
AMNISURE INTERNATIONAL, LLC |
MICHAEL FRIEDMAN |
| K083246 |
01/29/2009 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083248 |
01/29/2009 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083247 |
01/29/2009 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093387 |
11/27/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083317 |
01/29/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083318 |
01/29/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083319 |
01/29/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083617 |
01/27/2009 |
APIERON INSIGHT ENO SYSTEM |
APIERON, INC. |
NINA PELED |
| K082968 |
01/02/2009 |
APNEICARE CONNECTION CENTER/INTERNET ANALYSIS |
APNEICARE, LLC |
PAUL DRYDEN |
| K082504 |
01/27/2009 |
APOLLO ANTERIOR CERVICAL PLATE SYSTEM |
APOLLO SPINE, INC. |
PAMELA PAPINEAU, RAC |
| K093296 |
11/05/2009 |
ALEXIS LAPAROSCOPIC SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K091653 |
11/02/2009 |
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 |
ARK DIAGNOSTICS,INC |
JOHNNY VALDEZ |
| K092104 |
11/24/2009 |
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
HAMID IDRISSI |
| K082810 |
01/23/2009 |
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW |
ARTHREX, INC. |
NANCY HOFT |
| K092133 |
11/05/2009 |
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K083240 |
01/12/2009 |
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K083145 |
01/12/2009 |
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K083904 |
01/29/2009 |
ASAHI SUOH PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K092440 |
11/05/2009 |
ASCENSION CANNULATED SCREW SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K082231 |
01/12/2009 |
ASCENSION SILICONE PIP |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K092597 |
11/12/2009 |
CENTROS CHRONIC HEMODIALYSIS CATHETER SET |
ASH ACCESS TECHNOLOGY, INC. |
ROLAND WINGER |
| K082748 |
01/14/2009 |
ATRIUM PROLITE S MESH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K093187 |
11/05/2009 |
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
ELAINE APLAON |
| K092959 |
11/27/2009 |
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 |
AVITA CORPORATION |
JENNIFER REICH |
| K092313 |
11/04/2009 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
SUSAN OLINGER |
| K082704 |
01/09/2009 |
BIRTHTRACK (A.K.A. CLM) |
BARNEV, LTD. |
AHAVA STEIN |
| K092487 |
11/10/2009 |
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K082473 |
01/05/2009 |
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
NED L LUCE |
| K083757 |
11/18/2009 |
BPZ02 MULTIPURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
GLENN A DAVIES, O.D. |
| K090096 |
01/30/2009 |
ALL-IN-ONE CONTAINER |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
| K092877 |
11/17/2009 |
INDISCAL ASPIRATION DEVICE AND ACCESSORIES |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K083718 |
01/26/2009 |
BEAU RX SCAR CARE GEL |
BEAU RX SOLUTIONS, LLC. |
THOMAS L MCGRAW |
| K081822 |
01/21/2009 |
COULTER 6C CELL CONTROL, MODELS 628027 & A59925 |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K081641 |
01/16/2009 |
COULTER LIN-X LINEARITY CONTROL |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K091724 |
11/13/2009 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
BECTON DICKINSON & CO. |
SABA MODJARRAD |
| K082852 |
01/29/2009 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
| K091730 |
11/13/2009 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SABA MODJARRAD |
| K082787 |
01/12/2009 |
VITAL SIGNS MONITOR, MODEL: MD500B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K091272 |
11/10/2009 |
BESMED JET NEBULIZER BOTTLE SET |
BESMED HEALTH BUSINESS CORP. |
Ke-Min Jen |
| K083303 |
01/26/2009 |
LANDLEX, MODEL: 402X |
BESTEAM TECHNOLOGY INC. |
JUNNATA CHANG |
| K092549 |
11/16/2009 |
OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P |
BIO MEDICAL TECHNOLOGIES CO., LTD |
CATHRYN CAMBRIA |
| K091248 |
11/30/2009 |
MAXEMS, MODELS 1000 AND 2000 |
BIO PROTECH, INC. |
JUDY BURTON |
| K092732 |
11/25/2009 |
PROPENCIL ESU PENCIL |
BIO PROTECH, INC. |
KEVIN HAN |
| K092761 |
11/24/2009 |
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C |
BIO PROTECH, INC. |
JUDY BURTON |
| K081499 |
01/16/2009 |
HEALTH MANAGER, VERSION 1.1 |
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
MARION OTTO |
| K083274 |
01/08/2009 |
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER |
BIOCOMPATIBLES, INC. |
WAYNE RICHARDSON |
| K083681 |
01/16/2009 |
BIOLAND BLOOD PRESSURE MONITOR |
BIOLAND TECHNOLOGY LTD. |
DAVID LEE |
| K083682 |
01/09/2009 |
180W CERELAS D 980NM DIODE LASER, MODEL D180 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K093224 |
11/09/2009 |
DENSICHECK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K082941 |
01/07/2009 |
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
| K092341 |
11/30/2009 |
LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K082996 |
01/15/2009 |
BIOLOX DELTA OPTION CERAMIC HEADS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K091914 |
11/06/2009 |
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION |
BIONOSTICS, INC. |
MINNA RANNIKKO |
| K081787 |
01/27/2009 |
CAMLAB CRANIAL ORTHOSIS HELMET |
BIOSCULPTOR CORPORATION |
MARK MAZLOFF |
| K081258 |
01/06/2009 |
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
| K093032 |
11/13/2009 |
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET |
BIOSITE INCORPORATED |
MARA CALER |
| K091815 |
11/16/2009 |
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 |
Biotest Medical Corp. |
DIANE MANDELL HORWITZ |
| K093303 |
11/20/2009 |
SCOUTPRO 7F LONG CATHETERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K092009 |
11/06/2009 |
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 |
Boston Scientific Corporation |
JENNIFER KIMBALL |
| K093423 |
11/17/2009 |
LUNGPOINT PROCEDURE PLANNING |
BRONCUS TECHNOLOGIES, INC. |
NANCY ISAAC |
| K092191 |
11/25/2009 |
EXILIS, MODEL 5000 |
BTL INDUSTRIES LTD |
RICHARD VINCINS |
| K092090 |
11/30/2009 |
ERBELIFT HAND PUMP AND FLEXIBLE PROBE |
BYRNE MEDICAL INC. |
CHRIS HIERHOLZER |
| K092429 |
11/19/2009 |
ENDOGATOR |
BYRNE MEDICAL, INC. |
DON BYRNE |
| K083417 |
01/13/2009 |
INTRATEMP SOLUTION WARMER |
C CHANGE SURGICAL LLC |
PATRICK KAMMER |
| K092607 |
11/20/2009 |
AJUST ADJUSTABLE SINGLE INCISION SLING |
C.R. BARD, INC. |
JOHN C KNORPP |
| K083839 |
01/15/2009 |
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM |
C.R. BARD, INC. |
TERRI MORRIS |
| K090739 |
11/10/2009 |
BARD SACROCOLPOPEXY GRAFT |
C.R. BARD, INC. |
TERRI MORRIS |
| K082396 |
01/02/2009 |
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K093068 |
11/10/2009 |
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US |
C.R. BARD, INC. |
CINDY MOSS |
| K081924 |
01/07/2009 |
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE |
CALHEALTH INC |
Ke-Min Jen |
| K083273 |
11/19/2009 |
MICRODOT XTRA |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| K082521 |
01/16/2009 |
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K090915 |
11/18/2009 |
STERILE WATER FOR INHALATION FLEX BAG, USP |
CARDINAL HEALTH, INC. |
KIMBERLY SOUTHWELL |
| K093521 |
11/25/2009 |
GDXPRO |
CARL ZEISS MEDITEC INC |
JUDY A BRIMACOMBE |
| K090584 |
11/24/2009 |
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS |
CARL ZEISS SURGICAL GMBH |
MARK W SHEEHAN |
| K082518 |
01/16/2009 |
DUAL NEEDLE SUTURE PASSER SYSTEM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K092868 |
11/20/2009 |
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 |
CELLAVISION AB |
CONSTANCE G BUNDY |
| K092384 |
11/04/2009 |
LIQUICORD |
CENTRIX, INC. |
ROGER MASTRONY |
| K093134 |
11/27/2009 |
CERNER CAREAWARE IBUS |
CERNER CORP. |
SHELLEY S LOOBY |
| K080921 |
01/21/2009 |
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM |
CHEST M.I., INC. |
FUMIAKI KANAI |
| K091531 |
11/02/2009 |
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER |
CHOICE SPINE, LLP |
G.TODD HAWKINS |
| K080459 |
11/17/2009 |
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS |
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
CATHY CAMBRIA |
| K092362 |
11/02/2009 |
SLEEPWEAVER NASAL CPAP MASK |
CIRCADIANCE LLC |
DAVID GROLL |
| K092619 |
11/13/2009 |
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER |
CIVCO |
JAMES LEONG |
| K090326 |
11/25/2009 |
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
| K083771 |
01/30/2009 |
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
| K081908 |
01/16/2009 |
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K093184 |
11/06/2009 |
ENVOY GUIDING CATHETERS |
Codman & Shurtleff, Inc. |
KATHRYN LAROSE |
| K083770 |
11/23/2009 |
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
COLOPLAST A/S |
JANELL A COLLEY |
| K081537 |
01/22/2009 |
CFS FLEXIBLE |
COMFORT AND FLEXIBLE SYSTEMS |
JAY MANSOUR |
| K092160 |
11/27/2009 |
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES |
COMFORT RUBBER GLOVES IND. SDN. BHD. |
TAN KENG BENG |
| K093389 |
11/17/2009 |
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK |
COMPUTERIZED SCREENING, INC. |
SAM KUMAR |
| K092298 |
11/05/2009 |
MODIFICATION TO MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K083331 |
01/09/2009 |
CONFIDANT, MODEL 2.6 |
CONFIDANT INC. |
DANIEL R PLONSKI |
| K092954 |
11/06/2009 |
CADSTREAM VERSION 5 |
CONFIRMA, INC. |
BRENT LEWIS |
| K092359 |
11/02/2009 |
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A |
COOK IRELAND LTD |
TRACY MORIARTY |
| K083814 |
01/13/2009 |
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
KAREN WILK |
| K092730 |
11/20/2009 |
COSMEDENT BRUSHABLE COMPOSITE |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K092364 |
11/03/2009 |
MODEL 220 PATIENT MAGNET |
CYBERONICS, INC. |
KAREN STUEBER |
| K083795 |
01/21/2009 |
CYNOSURE SMARTLIPO MPX LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K081816 |
01/05/2009 |
VOCALIS AND VOCALIS SM |
CYTOPHIL INC |
Greg Johnson |
| K081815 |
01/05/2009 |
VOCALIS GEL |
CYTOPHIL INC |
Greg Johnson |
| K073593 |
01/29/2009 |
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 |
DELTEX MEDICAL LIMITED |
NEIL R ARMSTRONG |
| K083398 |
01/26/2009 |
CERCOM CEMENT |
DENALI R&D CORPORATION |
JAN G STANNARD |
| K083473 |
01/22/2009 |
CLEAR BRAVO |
DENALI R&D CORPORATION |
JAN STANNARD |
| K083201 |
01/26/2009 |
ZMATCH BLOCK |
DENTAIM CO., LTD. |
DAESUCK CHUN |
| K082973 |
01/29/2009 |
STER-MATE STERILE LAVAGE KIT |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K092473 |
11/25/2009 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE,INC |
LISA GILMAN |
| K092317 |
11/02/2009 |
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM |
DEROYAL INDUSTRIES, INC. |
GRACIE GREENWAY |
| K091309 |
11/05/2009 |
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX |
DGIMED ORTHO, INC |
SCOTT YOUNGSTROM |
| K092113 |
11/13/2009 |
STA - FREE PS CALIBRATOR |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K091382 |
11/16/2009 |
KRYPTONITE BONE CEMENT |
DOCTORS RESEARCH GROUP, INC. |
JUSTIN EGGLETON |
| K083258 |
01/30/2009 |
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K083059 |
01/30/2009 |
AIR SONIC SCALER |
DPM USA CORP. |
GEORGE ECHEVERRI |
| K092999 |
11/24/2009 |
NBP CUFF |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K081877 |
01/05/2009 |
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
GER VIJFVINKEL |
| K082863 |
01/09/2009 |
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) |
DYNAREX CORPORATION |
JAMES HURLMAN |
| K083769 |
01/14/2009 |
MODIFICATION TO URESTA PESSARY |
EASTMED INC. |
ROSHANA AHMED |
| K082406 |
01/14/2009 |
EXPANDABLE PEEK-OPTIMA IMPLANT |
EBI, L.P. |
VIVIAN KELLY |
| K092670 |
11/19/2009 |
BIODRIVE MICRO SCREW SYSTEM |
EBI,LLC D/B/A BIOMET TRAUMA |
SHIKHA GOLA |
| K092997 |
11/10/2009 |
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K090682 |
11/19/2009 |
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 |
EDWARDS LIFESCIENCES SERVICES GMBH |
NEIL R ARMSTRONG |
| K083470 |
01/23/2009 |
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 |
EDWARDS LIFESCIENCES, LLC. |
ERICA WALTERS |
| K092741 |
11/10/2009 |
COLOR LCD MONITOR, MODEL RADIFORCE MX241W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K090045 |
01/28/2009 |
COLOR LCD MONITOR, RADIFORCE RX320 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K083061 |
01/09/2009 |
ELLEX INNOVATIVE IMAGING EYE CUBED V4 |
ELLEX, INC. |
TOM DAVIS |
| K090796 |
11/25/2009 |
MULTI-BITE HOT BIOPSY FORCEPS |
ENDO-THERAPEUTICS, INC. |
MARK R WADDELL |
| K092400 |
11/06/2009 |
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 |
ENDOGASTRIC SOLUTIONS, INC. |
STEVE HOFFMAN |
| K082409 |
01/21/2009 |
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 |
ENDOPHOTONIX, INC |
KIRK S HONOUR |
| K081703 |
01/08/2009 |
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS |
ENTRA HEALTH SYSTEMS, LTD. |
CARLOS GONZALEZ |
| K082750 |
01/06/2009 |
ENTACT SEPTAL STAPLER, MODEL 610-00100 |
ENTRIGUE SURGICAL, INC. |
GABRIELE G NIEDERAUER |
| K083099 |
01/16/2009 |
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 |
EPS BIO TECHNOLOGY CORP. |
Y. C LEI |
| K081796 |
01/23/2009 |
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K083882 |
01/30/2009 |
MYLABFIVE |
ESAOTE EUROPE B.V. |
JAMIE AUSTIN |
| K091607 |
11/02/2009 |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K082955 |
01/15/2009 |
ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K091824 |
11/27/2009 |
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 |
ETHICON ENDO-SURGERY, INC. |
GLENDA MARSH |
| K093236 |
11/10/2009 |
ETHICON ENDO-SURGERYOPTICAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
RENEE ROWE |
| K080299 |
01/13/2009 |
RESPIFIT S, MODEL RS-LR1001004 |
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH |
DAVID LEVINE |
| K091657 |
11/19/2009 |
IMMUNOSCAN CCPLUS |
EURO-DIAGNOSTICA AB |
ANNIKA ANDERSSON |
| K093286 |
11/13/2009 |
POWERCROSS .018 OTW PTA DILATION CATHETER |
EV3 INC |
SARA BAKKER |
| K093301 |
11/06/2009 |
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K083151 |
01/22/2009 |
EXTREMITY MEDICAL SUTURE ANCHOR |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K082291 |
01/02/2009 |
A-LAP SET (A-LAP, EZAXESS, TROCAR) |
EZSURGICAL |
Kevin Walls |
| K083358 |
01/09/2009 |
LUBRICANO-ULTRASOUND |
FARCO PHARMA GMBH |
SETH A MAILHOT |
| K080964 |
01/14/2009 |
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
| K092271 |
11/17/2009 |
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 |
GE HEALTHCARE |
NICOLE LANDREVILLE |
| K093348 |
11/25/2009 |
3.0T 16 CHANNEL HEAD NECK SPINE COIL |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
ELIZABETH MATHEW |
| K072102 |
01/16/2009 |
EPIVISION SL SYSTEM |
GEBAUER MEDIZINTECHNIK GMBH |
KIMBERLEY DONEY |
| K092231 |
11/24/2009 |
GEBDI TRIBOS 501 |
GEBDI DENTAL-PRODUCTS GMBH |
THOMAS BISKUPSKI |
| K082488 |
01/13/2009 |
DIAZYME LP(A) ASSAY |
GENERAL ATOMICS |
Abhijit Datta |
| K082789 |
01/07/2009 |
G1B PULSE OXIMETER |
GENERAL MEDITECH, INC. |
Diana Hong |
| K080117 |
01/30/2009 |
PATIENT ISOLATION UNIT, MODEL G019-1000 |
GENTEX CORPORATION |
BARRY SHOPE |
| K081054 |
01/15/2009 |
GISH ARTERIAL FILTER WITH HA COATING |
GISH BIOMEDICAL, INC. |
HARVEY KNAUSS |
| K081881 |
01/23/2009 |
GISH TUBING AND CONNECTORS WITH HA COATING |
GISH BIOMEDICAL, INC. |
EDWARD F WADDELL |
| K081838 |
01/26/2009 |
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING |
GISH BIOMEDICAL, INC. |
MARTIN SELLERS |
| K083416 |
01/09/2009 |
REVOLVE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K092146 |
11/16/2009 |
XTEND ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K091367 |
11/05/2009 |
GDS-DCS |
GUIDED DELIVERY SYSTEMS |
BONNIE MCINERNEY |
| K091643 |
11/02/2009 |
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K092072 |
11/04/2009 |
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K083717 |
01/30/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K092163 |
11/16/2009 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K083652 |
01/21/2009 |
IBOND TOTAL ETCH |
HERAEUS KULZER GMBH |
CHERYL ZIMMERMAN |
| K093352 |
11/24/2009 |
HG III FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K092406 |
11/04/2009 |
ABG II MODULAR HIP STEM |
HOWMEDICA OSTEONICS CORP. |
ESTELA CELI |
| K092178 |
11/20/2009 |
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K081932 |
01/22/2009 |
ENDEARE BREAST PUMP |
HYGEIA MEDICAL, INC. |
JASPER BENKE |
| K081101 |
01/14/2009 |
SPECTRA-SYSTEM ABUTMENTS 2008 |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K081396 |
01/14/2009 |
SWISSPLANT DENTAL IMPLANT SYSTEM |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K091061 |
11/13/2009 |
IMPLICITGUIDE SURGICAL SUTURE SYSTEM |
IMPLICITCARE, LLC |
STEVE REITZLER |
| K091963 |
11/06/2009 |
VIGILANT EEG MONITOR, VIGILANT 2.0 |
INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
MANAN HATHI |
| K091157 |
11/17/2009 |
GLUCO LAB AUTO CODING, MODEL IGM-0022 |
INFOPIA CO., LTD |
Priscilla Chung |
| K090804 |
11/05/2009 |
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
LINDA MAGILL |
| K082943 |
01/06/2009 |
IROOT BP, MODEL IRBP 4609 |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K093564 |
11/25/2009 |
SVED WOUND TREATMENT SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
| K091743 |
11/02/2009 |
SEC VBR |
INNVOTEC SURGICAL, INC. |
JUSTIN EGGLETON |
| K091874 |
11/18/2009 |
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 |
INOMED MEDIZINTECHNIK GMBH |
YOLANDA SMITH |
| K093399 |
11/19/2009 |
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 |
INRAD |
MELISSA LALOMIA |
| K093256 |
11/17/2009 |
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 |
INRAD |
MELISSA LALOMIA |
| K082746 |
01/12/2009 |
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 |
INSIGHTRA MEDICAL, INC. |
TOM COLONNA |
| K092591 |
11/20/2009 |
ORTHOPANTOMOGRAPH OP30 |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
JOUNI ONNELA |
| K092395 |
11/19/2009 |
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM |
INTEGRA LIFESCIENCES CORP. |
DONNA MILLISKY |
| K081064 |
01/14/2009 |
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF |
IVD RESEARCH, INC. |
MICHAEL WIENHOLT |
| K091468 |
11/20/2009 |
IVD TECHNOLOGIES ACHRAB TEST KIT |
IVD TECHNOLOGIES |
Gary Lehnus |
| K090925 |
11/23/2009 |
MULTIPLE (APEX LOCATOR), MODEL RCM-7 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K082808 |
01/09/2009 |
IMAGESVR PACS |
JAGUAR TECHNOLOGY LIMITED |
Ke-Min Jen |
| K091686 |
11/13/2009 |
LEFORTE NEUROSYSTEM BONE SCREW |
JEIL MEDICAL CORPORATION |
SHIN KUK YOO |
| K082882 |
01/21/2009 |
A.V. FISTULA BLUNT NEEDLE SET |
JMS NORTH AMERICA CORP. |
MARIA F GRIFFIN |
| K092640 |
11/06/2009 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K092446 |
11/03/2009 |
INTRA LUX HEAD 3 LDSY |
KALTENBACH & VOIGT GMBH & CO. |
CLAUDIA ORTIZ |
| K071754 |
01/07/2009 |
NEO-VAGINA SURGERY SET AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K092797 |
11/19/2009 |
ACUTE AND CHRONIC CATHETER REPAIR KIT |
KENDALL |
Daniel Campion |
| K091192 |
11/02/2009 |
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX |
KENSEY NASH CORP. |
Alyssa Schwartz |
| K083701 |
01/09/2009 |
PANASIL INITIAL CONTACT AND PANASIL TRAY |
KETTENBACH GMBH & CO KG |
KRISTI KISTNER |
| K092167 |
11/02/2009 |
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 |
KIMBERLY-CLARK CORP. |
THOMAS KOZMA |
| K081797 |
01/22/2009 |
IMAGE STORAGE SYSTEM, MODEL KSS-400 |
KONAN MEDICAL, INC. |
GEORGE MYERS |
| K082399 |
11/05/2009 |
PECTUS STRUT |
KOROS USA, INC. |
TIBOR KOROS |
| K083387 |
01/16/2009 |
MODIFICATION TO KOWA NONMYD ALPHA-DIII |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K083510 |
01/08/2009 |
KUBTEC XPERT 20 |
KUB TECHNOLOGIES, INC |
JOSEPH M AZARY |
| K092499 |
11/20/2009 |
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K092498 |
11/20/2009 |
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K092656 |
11/24/2009 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K092153 |
11/20/2009 |
SKYLINE 55, MODEL VER 1 |
LARSEN & TOUBRO LIMITED |
SHAILESH BHOSALE |
| K081878 |
01/27/2009 |
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM |
LEMAITRE VASCULAR, INC. |
ERIN DALY |
| K091568 |
11/05/2009 |
LH-75 PHOTOTHERAPY SYSTEM |
LERNER MEDICAL DEVICES, INC. |
ZAFIRIOS F GOURGOULIATOS |
| K082351 |
01/02/2009 |
NEPTUNE HYPERBARIC VENTILATOR |
LEVEL-5, INC. |
HOWARD M HOLSTEIN |
| K090004 |
01/15/2009 |
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K093499 |
11/23/2009 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CHERITA JAMES |
| K083865 |
01/28/2009 |
PILOT SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K091625 |
11/03/2009 |
EPICARE-DUO LASER SYSTEM |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
| K091754 |
11/13/2009 |
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 |
LUNE GROUP LTD. |
MORRIS WAXLER |
| K082035 |
01/29/2009 |
MAICO MB 11 WITH BERAPHONE PROBE |
MAICO DIAGNOSTICS |
DANIEL EGGAN |
| K082212 |
01/22/2009 |
SYRINGE WITH HANDI-FIL |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
DALE MOORE |
| K091241 |
11/06/2009 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K091263 |
11/19/2009 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) |
MATERIALISE N.V. |
KARL VON BERGE |
| K090098 |
01/30/2009 |
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON |
MAXIM HYGIENE PRODUCTS, INC. |
E.J. Smith |
| K083872 |
01/15/2009 |
IMNS MEDACTA NAVIGATION SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATLIE J KENNEL |
| K083123 |
11/24/2009 |
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES |
MEDART A/S |
OLAV BALLE-PETERSON |
| K093309 |
11/24/2009 |
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K092737 |
11/17/2009 |
EASYRA MG REAGENT, MODEL 10220 |
MEDICA CORP. |
Photios Makris |
| K082511 |
01/16/2009 |
MEDIGARD BLOOD COLLECTION DEVICE |
MEDIGARD LIMITED |
EJ Smith |
| K081956 |
01/09/2009 |
MEDINOL X-SUIT NIR BILIARY METALLIC STENT |
MEDINOL LTD. |
LEO L BASTA |
| K081536 |
01/23/2009 |
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED |
MEDISIZE BV |
|
| K082905 |
01/12/2009 |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC |
MEDRAD, INC. |
FORTUNATO ALDAPE |
| K092239 |
11/17/2009 |
ROSA SURGICAL DEVICE, MODEL ROSA 1.1 |
MEDTECH S.A. |
BERTIN NAHUM |
| K090780 |
11/20/2009 |
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K091795 |
11/20/2009 |
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K091813 |
11/17/2009 |
INTREPID SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K082917 |
01/09/2009 |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K082728 |
01/16/2009 |
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MELISA LANSKY |
| K083537 |
01/15/2009 |
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K081153 |
01/30/2009 |
NOVEL SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
JUNG BAE BANG |
| K083464 |
01/30/2009 |
PREMIER CAMPY, MODEL 618096 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN D ROLIH |
| K093160 |
11/05/2009 |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
MICROVENTION, INC. |
Naomi Gong |
| K092702 |
11/20/2009 |
MICRUS MICROCATHETER, MODEL COURIER 270 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K083646 |
01/02/2009 |
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K083754 |
11/20/2009 |
MINI LAP ELECTROCAUTERY INSTRUMENTS |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K081033 |
01/15/2009 |
MIROXI |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K083082 |
01/13/2009 |
MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS |
MOOR INSTRUMENTS LTD. |
XIABING HUANG |
| K082526 |
01/05/2009 |
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) |
MRI CARDIAC SERVICES, INCORPORATED |
SCOTT HUBER |
| K081811 |
01/21/2009 |
CARE3 PLUS |
NAKANISHI, INC. |
KEITH BARRITT |
| K083430 |
01/15/2009 |
REAL-TIME PCR INTERNAL CONTROL 2B SET |
NANOGEN, INC. |
E. JOSEPH MCMULLEN |
| K093337 |
11/17/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM |
NANOSPHERE, INC |
GREGORY SHIPP |
| K093366 |
11/24/2009 |
NMI PICC II |
NAVILYST MEDICAL, INC. |
LORRAINE HANLEY |
| K083916 |
01/14/2009 |
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K083907 |
01/13/2009 |
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K083332 |
01/09/2009 |
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K082710 |
01/23/2009 |
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET |
NEOCHILD, LLC |
RHETT BOLEN |
| K083818 |
01/21/2009 |
UNIVERSAL ELECTRODES |
NEUROMETRIX, INC. |
RAINER MAAS |
| K083877 |
01/13/2009 |
FLYING DIAGNOSTIC ULTRASOUND SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K090888 |
11/18/2009 |
NEWPORT HT70 FAMILY OF VENTILATORS |
NEWPORT MEDICAL INSTRUMENTS, INC. |
DANA RODRIGUEZ |
| K092899 |
11/10/2009 |
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 |
NINGBO XINGAOYI MAGNETISM CO., LTD. |
JIANG MOWEN |
| K092246 |
11/12/2009 |
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K083578 |
01/16/2009 |
NORAS CPC MULTIFUNCTIONAL COIL |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K092501 |
11/12/2009 |
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL |
NOVOCOL, INC. |
STEVE RUDOLPH |
| K081377 |
01/15/2009 |
NUVASIVE SURGICAL MESH SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K083323 |
01/28/2009 |
NUVO VERDE LED LIGHTING SYSTEM |
NUVO, INC. |
CURT V SCHAAFF |
| K083155 |
01/13/2009 |
HD CAMERA HEAD OTV-S7PROH-HD-L08E |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K093451 |
11/20/2009 |
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K090044 |
01/22/2009 |
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C |
ONCOLOG MEDICAL QA AB |
JAN TORNQVIST |
| K092522 |
11/20/2009 |
ACU007S |
ONCOLOGY SYSTEMS, INC. |
JENNIFER WILLIAMS |
| K092374 |
11/17/2009 |
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN |
OPHTHALMIC IMAGING SYSTEMS |
ANDREA AMBROSE |
| K083286 |
01/30/2009 |
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K072882 |
01/08/2009 |
PAIN VISION, MODEL PS-2100 |
OSACHI CO., LTD. |
JAMES R GREENWOOD |
| K083618 |
01/28/2009 |
PACS SCAN |
PACSGEAR, INC. |
IAN GORDON |
| K083494 |
01/06/2009 |
ULTIMA FIVE |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K090195 |
11/20/2009 |
PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K083231 |
01/26/2009 |
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT |
PANTHERA PRODUCTION AB |
STUART R GOLDMAN |
| K082799 |
01/27/2009 |
HDS HI 1.54 |
PARAGON VISION SCIENCES |
WILLIAM MEYERS |
| K083176 |
01/23/2009 |
PASTURE, MODELS: F550, A520 |
PASTURE PHARMA PTE LTD |
SARAH HASSAN |
| K083837 |
01/13/2009 |
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K083489 |
01/23/2009 |
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K082138 |
01/23/2009 |
AIRGENT, MODEL AG7000010 |
PERFACTION, INC. |
JONATHAN S KAHAN |
| K093307 |
11/06/2009 |
ASEPT PLEURAL DRAINAGE SYSTEM |
PFM MEDICAL, INC |
Salvadore Palomares, RAC |
| K092050 |
11/20/2009 |
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 |
PHADIA AB |
MARTIN MANN |
| K091862 |
11/20/2009 |
NESSI SPACER |
PHARMACARIBE |
PAUL DRYDEN |
| K091176 |
11/13/2009 |
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K083517 |
01/16/2009 |
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K091927 |
11/03/2009 |
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K081307 |
01/16/2009 |
OMNILUX CLEAR-U |
PHOTO THERAPEUTICS, INC. |
SUE DARCY |
| K091031 |
11/17/2009 |
PIONEER SURGICAL NANOSS BVF-E |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE |
| K091965 |
11/24/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
| K083453 |
01/21/2009 |
COSTORSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K091053 |
11/20/2009 |
PROPARAFLU+ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K082089 |
01/13/2009 |
PRUMYX CREAM |
PRUGEN, INC. |
ROBERT L KNECHTEL |
| K080431 |
01/08/2009 |
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 |
QUANTRX BIOMEDICAL CORPORATION |
NATALIE J KENNEL |
| K092040 |
11/18/2009 |
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K083264 |
01/22/2009 |
RAYAUTOPLAN 1.0 |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K083856 |
01/22/2009 |
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 |
RELIEVANT MEDSYSTEMS, INC. |
Mark Smutka |
| K082983 |
01/02/2009 |
RESSCAN-PRO |
RESMED LTD. |
DAVID D'CRUZ |
| K082979 |
01/02/2009 |
S8 ADVANCE |
RESMED LTD. |
DAVID D'CRUZ |
| K082605 |
01/13/2009 |
VPAP AUTO WITH HUMIDAIRE 3I |
RESMED LTD. |
DAVID D'CRUZ |
| K082660 |
01/09/2009 |
V60 VENTILATOR, MODEL V8000 |
RESPIRONICS CALIFORNIA, INC. |
MARA CALER |
| K083874 |
01/26/2009 |
GALAXY |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW P ZELTWANGER |
| K082866 |
01/30/2009 |
REVOLUTIONFULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW ZELTWANGER |
| K083721 |
01/08/2009 |
MODIFICATION TO ZENIEVA |
RIVER'S EDGE PHARMACEUTICALS, LLC |
SANDRA R KIRCUS |
| K093089 |
11/13/2009 |
MAGNUM NAIL |
ROBERT REID INC. |
KAREN WARDEN |
| K081193 |
01/16/2009 |
COBAS INTEGRA 400/800 BILIRUBIN TOTAL |
Roche Diagnostics |
JENNIFER TRIBBETT |
| K092168 |
11/16/2009 |
ELECSYS HCG+B CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K092320 |
11/03/2009 |
ELECSYS PRECICONTROL THYROAB |
Roche Diagnostics |
Sarah Baumann |
| K092888 |
11/10/2009 |
ELECSYS TOXO IGG CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
JANE E PHILLIPS |
| K083847 |
01/30/2009 |
MARVEL PEDIATRIC WHEELCHAIR |
ROGUE WHEELCHAIRS INC |
KATHRYN RONALDS |
| K082115 |
01/15/2009 |
PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K092858 |
11/10/2009 |
SAFERSONIC SONOGRAPHY COVER |
SAFERSONIC MEDIZINPRODUKTE GMBH |
Kevin Walls |
| K093253 |
11/12/2009 |
AMID STAPLER |
SAFESTITCH LLC |
STEWART DAVIS |
| K092685 |
11/24/2009 |
PNEUMOTHERML, MODEL: 5800 |
SALTER LABS |
TERRY NEWTON |
| K093453 |
11/30/2009 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
HOWARD FIDEL |
| K083553 |
01/16/2009 |
NASO-LARYNGO-PHARYNGOSCOPE |
SCHOELLY IMAGING, INC. |
F. DAVID ROTHKOPF |
| K081548 |
01/29/2009 |
ANTERIOR BUTTRESS PLATE |
SCIENT'X USA, INC. |
JOHN SANDERS |
| K083089 |
01/13/2009 |
NEWPORT SPINAL SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K093512 |
11/20/2009 |
ENCOR BREAST BIOPSY SYSTEM |
SENORX, INC. |
EBEN GORDON |
| K093359 |
11/27/2009 |
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 |
SHANGHAI LITTLE DOCTOR CO. LIMITED |
JANUSUN WANG |
| K093100 |
11/24/2009 |
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) |
SHENZHEN COMFORT TECHNOLOGY CO., LTD. |
JEAN ASQUITH |
| K091664 |
11/16/2009 |
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C |
SHENZHEN GSD TECH. CO., LTD. |
Diana Hong |
| K090578 |
11/06/2009 |
SHIMADZU COLLIMATOR R-30H |
SHIMADZU CORP. |
DON KARLE |
| K081911 |
01/15/2009 |
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K092993 |
11/20/2009 |
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083159 |
01/26/2009 |
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 |
SIEMENS HEALTHCARE DIAGNOSTICS |
JANET M FOSE |
| K083175 |
01/26/2009 |
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 |
SIEMENS HEALTHCARE DIAGNOSTICS |
JANET M FOSE |
| K081895 |
01/08/2009 |
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
PHILIP LIU |
| K083149 |
01/14/2009 |
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
| K083166 |
01/13/2009 |
SPECIALTY COILS FOR THE MAGNETOM ESSENZA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELIZABETH LAZARO |
| K092401 |
11/17/2009 |
SINEXUS SINUS STENT GEN 2, MODEL 1999-25 |
SINEXUS, INC. |
AMY CONUEL |
| K091714 |
11/18/2009 |
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 |
SKYFINE INC. LIMITED |
MICHAEL LEE |
| K083635 |
01/30/2009 |
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
CHRISTINA FLORES |
| K083226 |
01/30/2009 |
SMITH & NEPHEW PEEK INTERFERENCE SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHY REDDIG |
| K083032 |
01/07/2009 |
PERI-LOC BONE PLATING AND SCREW SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K092386 |
11/03/2009 |
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K083528 |
01/28/2009 |
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K092657 |
11/04/2009 |
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E |
SMITHS MEDICAL ASD, INC. |
CINDY ENGELHARDT |
| K083522 |
01/09/2009 |
SONY UP-DF750 DIGITAL FILM IMAGER |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K092463 |
11/05/2009 |
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K093501 |
11/24/2009 |
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION |
SPACELABS MEDICAL INC. |
DAVID GERAGHTY |
| K083209 |
01/27/2009 |
ACRYLIC HERBST SPLINT APPLIANCE |
SPECIALTY APPLIANCE WORKS, INC. |
CAROLYN THOMAS |
| K092378 |
11/02/2009 |
SPECTRANETICS VISISHEATH DILATOR SHEATH |
SPECTRANETICS CORP. |
CHERYL HASTINGS |
| K083167 |
01/13/2009 |
PHENIX CERVICAL INTERBODY DEVICE |
SPINAL DEVICES, LLC |
RICHARD JANSEN |
| K082353 |
01/22/2009 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K092659 |
11/17/2009 |
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 |
SPINAL USA |
JEFFREY JOHNSON |
| K083743 |
01/13/2009 |
CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K093170 |
11/04/2009 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K092420 |
11/19/2009 |
KRD1 PEDICLE SCREW SYSTEM |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
| K092464 |
11/09/2009 |
SPINEOLOGY FACET SCREW |
SPINEOLOGY, INC. |
Karen Roche |
| K091865 |
11/13/2009 |
SPORT-ELEC BODY CONTROL SYSTEM |
SPORT-ELEC |
KIMBERLY JONES |
| K083835 |
01/23/2009 |
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR |
ST. JUDE MEDICAL |
WILLIAM MCKELVEY |
| K093130 |
11/04/2009 |
ENGAGE TR INTRODUCER |
ST. JUDE MEDICAL |
LINH PHAM |
| K080179 |
01/07/2009 |
REFLEXION HD HIGH-DENSITY MAPPING CATHETER |
ST. JUDE MEDICAL |
ANDREA HUDACK |
| K083060 |
01/09/2009 |
REPROCESSED HARMONIC SCALPEL |
STERILMED, INC. |
DENNIS TOUSSAINT |
| K092368 |
11/03/2009 |
REPROCESSED PULSE OXIMETER SENSORS |
STERILMED, INC. |
GARRETT AHLBORG |
| K092490 |
11/04/2009 |
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 |
STERIS Corporation |
ROBERT F SULLIVAN |
| K073618 |
01/07/2009 |
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK |
STERIS Corporation |
JOHN R SCOVILLE |
| K092434 |
11/10/2009 |
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM |
STERNGOLD |
LEE CLERMONT |
| K083162 |
01/12/2009 |
STINGRAY ELECTROSURGICAL FORCEPS |
STINGRAY SURGICAL PRODUCTS, INC |
DANIEL KAMM |
| K093408 |
11/12/2009 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
NISHITH DESAI |
| K093410 |
11/12/2009 |
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY |
SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE |
FRANK GIANELLI |
| K093402 |
11/12/2009 |
AUTOSUTURE EEA ORVIL |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO |
REBECCA RONNER |
| K092504 |
11/05/2009 |
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
| K091650 |
11/24/2009 |
AXS-590 SERIES |
SWR INTERNATIONAL, LTD |
MARTIN J LEIGHTON |
| K083297 |
01/28/2009 |
PITT-EASY DENTAL IMPLANT SYSTEM |
SYBRON IMPLANT SOLUTIONS GMBH |
Wendy Garman |
| K090605 |
11/06/2009 |
CLAMPFIX |
SYNTHES (USA) |
JASON LIPMAN |
| K092556 |
11/17/2009 |
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS |
SYNTHES (USA) |
KARL J NITTINGER |
| K092609 |
11/17/2009 |
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K083025 |
01/14/2009 |
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K080782 |
01/30/2009 |
NITI-S ESOPHAGEAL STENT |
TAEWOONG MEDICAL CO., LTD |
CATHRYN N CAMBRIA |
| K091814 |
11/20/2009 |
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE |
TaiDoc Technology Corporation |
ERICA LI |
| K083664 |
01/09/2009 |
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K082482 |
01/30/2009 |
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 |
TaiDoc Technology Corporation |
SOPHIE LIN |
| K083046 |
01/16/2009 |
FORA TELEHEALTH SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K093270 |
11/04/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN EXCELLENCE GLOVE CO., LTD. |
CHU XIAOAN |
| K093277 |
11/30/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN GREEN HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093272 |
11/30/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HUAMEI HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093276 |
11/04/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K082598 |
01/07/2009 |
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE |
TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. |
CHU XIAOAN |
| K092773 |
11/24/2009 |
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST |
TECRES SPA |
CHRISTINE BRAUER |
| K083337 |
01/27/2009 |
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K083194 |
01/16/2009 |
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
JUNKO KUROSAWA |
| K090009 |
01/28/2009 |
THD SLIDE ONE |
THD SPA |
MAUREEN O'CONNELL |
| K082712 |
01/02/2009 |
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K081378 |
01/14/2009 |
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS |
Thermo Fisher Scientific |
JACK ROGERS |
| K092230 |
11/25/2009 |
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 |
TIME MEDICAL LIMITED |
Diana Hong |
| K072971 |
01/13/2009 |
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS |
TOPCON MEDICAL SYSTEMS, INC. |
JONATHAN S KAHAN |
| K082754 |
01/27/2009 |
AEQUALIS HUMERAL NAIL SYSTEM |
TORNIER |
BRIAN HODOREK |
| K081279 |
01/23/2009 |
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 |
TRANSFER TECHNOLOGY |
JOSEPH J ARBOUR |
| K082617 |
01/15/2009 |
TRAUSON GENERAL SPINAL SYSTEM (GSS) |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K081230 |
01/13/2009 |
TRAUSON INTRAMEDULLARY NAIL |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K091725 |
11/09/2009 |
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) |
U&I CORP. |
SUNG YOUN CHO |
| K083647 |
01/23/2009 |
VALO, MODEL 5919 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K093462 |
11/20/2009 |
SONIX ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K092567 |
11/25/2009 |
MODIFICATION TO UNIGRAFT |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K092461 |
11/05/2009 |
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 |
UNITED STATES ENDOSCOPY GROUP, INC. |
CRAIG MOORE |
| K092871 |
11/30/2009 |
TRILOGY MX |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K093291 |
11/17/2009 |
VARIAN INTERSTITIAL TITANIUM NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K092563 |
11/04/2009 |
GATOR CLIPSEAL PLUG |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K081846 |
01/28/2009 |
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K091750 |
11/04/2009 |
GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K082337 |
01/15/2009 |
MINNIE SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K091924 |
11/18/2009 |
VPS CATHETER |
VASONOVA INC. |
KIM TOMPKINS |
| K093146 |
11/30/2009 |
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 |
VERAN MEDICAL TECHNOLOGIES, INC. |
SCOTT WRIGHTSTONE |
| K092135 |
11/23/2009 |
MODIFICATION TO IVENT 101 |
VERSAMED MEDICAL SYSTEMS LTD. |
ADRIANNE LENZ |
| K082466 |
01/09/2009 |
XYCOR SPINAL IMPLANT |
VERTEBRATION,INC |
BARBARA FANT |
| K092693 |
11/25/2009 |
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS |
VIRAMED BIOTECH AG |
BARRY MENEFEE |
| K092439 |
11/30/2009 |
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K083725 |
01/22/2009 |
RADPRO ION |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K090532 |
11/13/2009 |
T.E.A.R. TECH3 |
VISION QUEST INDUSTRIES, INC. |
WALLACE FISCHER |
| K092822 |
11/03/2009 |
CAPRI APPLICATOR |
VIVARAY, INC. |
GEORGE HERMANN |
| K091752 |
11/12/2009 |
VIZTEK WL |
VIZTEK, INC. |
DANIEL KAMM |
| K083036 |
01/12/2009 |
VOCO PROFLUORID L |
VOCO GMBH |
M. PLAUMANN |
| K090023 |
01/30/2009 |
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K082626 |
01/16/2009 |
PAM 3000 |
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD. |
EFRAIM GAVRILOVICH |
| K080134 |
01/23/2009 |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) |
WONJIN MULSAN CO., LTD. |
BRANDON CHOI |
| K083150 |
01/15/2009 |
G-FORCE TENODESIS SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K092790 |
11/02/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO BOXIANG PLASTIC & RUBBER CO., LTD. |
JOHN ZHAO |
| K082936 |
01/12/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO LITONG PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
| K092377 |
11/03/2009 |
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K091973 |
11/17/2009 |
METASUL TAPER LINERS, METASUL FEMORAL HEADS |
ZIMMER GMBH |
BENJAMIN C CURSON |
| K091003 |
11/24/2009 |
ZIMMER MMC CUP |
ZIMMER GMBH |
BENJAMIN C CURSON |
