FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K060117 |
02/22/2006 |
BOVIE BUTTON REMOTE HAND SWITCH |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
K062770 |
12/14/2006 |
COPILOT HEALTH MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
MARY ROSE |
K062582 |
12/14/2006 |
SUPRACOR BALLOON CATHETER |
ABIOMED, INC. |
ROBERT T.V. KUNG |
K052732 |
02/24/2006 |
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P |
ABRACAIR, INC. |
DAVID CHANGARIS |
K062795 |
12/11/2006 |
MUGARD MUCOADHESIVE ORAL WOUND RINSE |
ACCESS PHARMACEUTICALS, INC |
DAVID NOWOTNIK, PH.D. |
K053032 |
02/09/2006 |
ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
K063460 |
12/07/2006 |
ACUMED CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
K053094 |
02/06/2006 |
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 |
ADVANCED BIO-SURFACES, INC. |
PHILLIP B JARVI |
K053473 |
02/03/2006 |
MAESTRO MDTL LASER SYSTEM |
ADVANCED MEDICAL TECHNOLOGIES, INC. |
M. JOYCE HEINRICH |
K063080 |
12/12/2006 |
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
AMY CLENDENING |
K063127 |
12/22/2006 |
ENTEROCOCCUS FAECALIS PNA FISH |
ADVANDX, INC. |
Amy Aulwes |
K063013 |
12/01/2006 |
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S |
AEARO COMPANY |
ANN L PHILLIPS |
K053389 |
02/15/2006 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP, INC. |
MATTHEW M HULL |
K063017 |
12/27/2006 |
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM |
AESCULAP, INC. |
MATTHEW M HULL |
K053390 |
02/06/2006 |
COLUMBUS (CR) TOTAL KNEE SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
K060152 |
02/03/2006 |
MODIFICATION TO S4 SPINAL SYSTEM |
AESCULAP, INC. |
Lisa Boyle |
K062217 |
12/13/2006 |
AESKULSKA BETA2-GLYCO-A |
AESKU, INC |
DAVID BELL |
K052439 |
02/07/2006 |
AESKULISA GLIA A AND AESKULISA GLIA G |
AESKU.DIAGNOSTICS |
STANLEY AMMONS |
K062951 |
12/12/2006 |
TAP III ANTI-SNORING DEVICE |
AIRWAY MANAGEMENT INC. |
DARREN HENDERSON |
K062971 |
12/18/2006 |
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
K060091 |
02/17/2006 |
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K053316 |
02/13/2006 |
REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K060049 |
02/24/2006 |
REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K062371 |
12/04/2006 |
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM |
ALPHASPINE, INC. |
MIKE ENSIGN |
K051636 |
02/17/2006 |
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES |
ALTATEC GMBH |
TINA STEFFANIE-OAK |
K053070 |
02/13/2006 |
CONTOUR II SPINAL SYSTEM |
ALTIVA CORP. |
JOHN KAPTIAN |
K063379 |
12/11/2006 |
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 |
AMEDICA BIOTECH, INC. |
Jeff Chen |
K051525 |
02/17/2006 |
ARX SPINAL SYSTEM |
AMEDICA CORP. |
ROBERT M WOLFARTH |
K063015 |
12/20/2006 |
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 |
AMEDITECH, INC. |
JOHN WU |
K062794 |
12/07/2006 |
PRN THERMALCARE, MODEL 3000 |
AMERICAN HEALTHCARE PRODUCTS, INC. |
KENT D ELLIS |
K053371 |
02/03/2006 |
AMS MALE TRANSOBTURATOR SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
FRANK B FREEDMAN |
K060150 |
02/23/2006 |
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM |
ANDANTE MEDICAL DEVICES LTD. |
DORIT WINITZ |
K063519 |
12/01/2006 |
DYNAMIC GAS SCAVENGING SYSTEM (DGSS) |
ANESTHETIC GAS RECLAMATION LLC |
JAMES M BERRY |
K053103 |
02/01/2006 |
INTERFACE |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
K062664 |
12/06/2006 |
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 |
APEX MEDICAL CORP. |
ALAN CHANG |
K063244 |
12/27/2006 |
ARC SURGICAL BONE REDUCTION SCREW |
ARC SURGICAL LLC. |
ED BOEHMER |
K052719 |
12/05/2006 |
URITEST 10 URINALYSIS REAGENT STRIPS |
ARJ MEDICAL, INC. |
AARON BEHAR |
K062100 |
12/05/2006 |
ARJOWRAP 47/100 AND 47/88 |
ARJO WIGGINS MEDICAL, INC. |
ARTHUR WARD |
K063068 |
12/20/2006 |
FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 |
ARKRAY USA, INC. |
TOM SPEIKERS |
K063424 |
12/21/2006 |
FILM DIGITZER, MODEL 2908 MAMMO PRO |
ARRAY CORP. |
TAKASHI INAMI |
K063479 |
12/13/2006 |
ARTHREX PUSHLOCK |
ARTHREX, INC. |
ANN WATERHOUSE |
K063538 |
12/01/2006 |
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K053461 |
02/03/2006 |
EZLOC FEMORAL FIXATION DEVICE |
ARTHROTEK, INC. |
SUSAN ALEXANDER |
K060019 |
02/17/2006 |
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) |
ARTRON LABORATORIES, INC. |
JERRY ZHENG |
K062692 |
12/13/2006 |
BIS BILATERAL SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
RENEE GOULD |
K062277 |
12/20/2006 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE |
ATLANTIS COMPONENTS, INC. |
FRANKLIN UYLEMAN |
K061680 |
12/15/2006 |
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER |
ATRIUM MEDICAL CORP. |
JOSEPH P DEPAOLO |
K062198 |
12/19/2006 |
SUNSPOTS PRE-GELLED SURFACE ELECTRODES |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
K063194 |
12/04/2006 |
TUFFLEX POLYESTER SUTURE |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
K062714 |
12/15/2006 |
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY A DOUCETTE |
K062905 |
12/29/2006 |
NIO FUSION 4MP; MDNC 4130 |
BARCOVIEW |
LIEVEN DE WANDEL |
K063331 |
12/19/2006 |
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
LISA C GRANEY |
K053512 |
02/16/2006 |
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
K063276 |
12/28/2006 |
CLINITEK ADVANTUS, MODEL 1420 |
BAYER HEALTHCARE, LLC |
NOOR MALKI |
K060130 |
02/13/2006 |
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K060256 |
02/27/2006 |
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K063301 |
12/08/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K060042 |
02/14/2006 |
LANDLEX, MODEL P100X |
BESTEAM TECHNOLOGY INC. |
JEFF CHANG |
K063643 |
12/27/2006 |
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
JACKIE BUCKLEY |
K062211 |
12/08/2006 |
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K062213 |
12/08/2006 |
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
BIO-RAD LABORATORIES, INC. |
DAVID BHEND |
K063400 |
12/01/2006 |
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
K053099 |
02/14/2006 |
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
K053595 |
02/28/2006 |
CURAY CUSTOM SEED ARRAY |
BIOLUCENT, INC. |
SHERYL HIGGINS |
K063492 |
12/21/2006 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOHN TENLLADO |
K062997 |
12/08/2006 |
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K060694 |
12/11/2006 |
MODULAR HYBRID GLENOID |
BIOMET MANUFACTURING CORP. |
PATRICIA SANDBORN BERES |
K060131 |
02/15/2006 |
OSS-BODIES PROXIMAL TIBIAL SLEEVE |
BIOMET MANUFACTURING CORP. |
TRACY BICKEL JOHNSON |
K052089 |
02/17/2006 |
XR-SERIES BI-METRIC FEMORAL COMPONENTS |
BIOMET MANUFACTURING, INC. |
PATRICIA SANDBORN-BERES |
K053635 |
02/21/2006 |
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
K063398 |
12/05/2006 |
ESA LEADCARE II LEAD CONTROL |
BIONOSTICS, INC. |
RANDY BYRD |
K062819 |
12/04/2006 |
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOPLATE, INC. |
JESUS T FARINAS |
K063343 |
12/13/2006 |
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM |
BIOPTIGEN, INC. |
RUSSELL PAGANO |
K053329 |
02/15/2006 |
KORLEX-GR GINGIVAL RETRACTION PASTE |
BIOTECH ONE, INC. |
KAREN UYESUGI |
K063505 |
12/12/2006 |
VISUALASE ENVISION SOFTWARE SYSTEM |
BIOTEX, INC. |
MATHEW FOX |
K063237 |
12/08/2006 |
THERACAL LC |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
K052608 |
02/01/2006 |
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
K060350 |
02/24/2006 |
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TURNING |
K060283 |
02/22/2006 |
TRANSET SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
K063313 |
12/05/2006 |
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) |
BOSTON SCIENTIFIC CORP. |
DONNA PAGE |
K063493 |
12/21/2006 |
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 |
BOSTON SCIENTIFIC CORP. |
CHRISTINE DUNBAR |
K062750 |
12/04/2006 |
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 |
BOSTON SCIENTIFIC CORP. |
ALLYSON BARFORD |
K053500 |
02/03/2006 |
FRAMELESS RADIOSURGERY COMPONENTS |
BRAINLAB AG |
RAINER BIRKENBACH |
K052966 |
02/13/2006 |
CI KNEE, CI MI TKR |
BRAINLAB, AG |
RAINER BIRKENBACH |
K053127 |
02/09/2006 |
IPLAN |
BRAINLAB, AG |
RAINER BIRKENBACH |
K063028 |
12/12/2006 |
VECTORVISION HIP SR |
BRAINLAB, AG |
RAINER BIRKENBACH |
K050086 |
02/17/2006 |
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING |
BRENNEN MEDICAL, INC. |
KENNETH B HERLAND |
K063446 |
12/15/2006 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
PEGGY KEIFFER |
K060004 |
02/22/2006 |
CALDERA MESH |
CALDERA MEDICAL, INC. |
MARLA KENGEN |
K053424 |
02/22/2006 |
POPMESH |
CALDERA MEDICAL, INC. |
MARLA KENGEN |
K063074 |
12/27/2006 |
CANDELA 3630 LASER SYSTEM |
CANDELA CORP. |
JEFFREY ROBERTS |
K063073 |
12/20/2006 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS |
CANDELA CORP. |
JEFFERY ROBERTS |
K063072 |
12/20/2006 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES |
CANDELA CORP. |
JEFFERY ROBERTS |
K063308 |
12/04/2006 |
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 |
CARBYLAN BIOSURGERY |
ROXANNE DUBOIS |
K052125 |
02/08/2006 |
CARBONAID GAS DIFFUSER |
CARDIA INNOVATION AB |
JEFFREY R SHIDEMAN |
K051817 |
12/06/2006 |
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM |
CARDIVA MEDICAL, INC. |
KARIN GASTINEAU |
K062314 |
12/22/2006 |
HORUS LASER KERATOME |
CARL ZEISS MEDITEC AG |
KENT W JONES |
K063087 |
12/11/2006 |
MODIFICATION TO MODEL 750 SERIES MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K063070 |
12/14/2006 |
APERFIX TIBIAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
Floyd Larson |
K053301 |
02/03/2006 |
CEDARA I-RESPONSE CEDARA PET/CT |
CEDARA SOFTWARE CORP. |
CAROL NAKAGAWA |
K062897 |
12/14/2006 |
C-U2 |
CEFLA S.C.R.L. |
Claude Berthoin |
DEN060008 |
02/03/2006 |
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
K062948 |
12/08/2006 |
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B |
CEPHEID |
RUSSEL K ENNS |
K062280 |
12/11/2006 |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE |
CEREMED, INC. |
TADEUSZ WELLISZ |
K053223 |
02/24/2006 |
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION |
CHATTANOOGA GROUP |
MICHAEL TREAS |
K050757 |
02/23/2006 |
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE |
CHEMENCE MEDICAL INC. |
SCOTT LEAL |
K060008 |
02/02/2006 |
AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
K062922 |
12/13/2006 |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
K063579 |
12/14/2006 |
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
K053376 |
02/16/2006 |
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 |
CHUNG CHENG ELECTRIC HEATING CO., LTD. |
JENNIFER REICH |
K050828 |
02/28/2006 |
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
K051175 |
02/17/2006 |
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION |
CIVENT COMMUNICATIONS LTD |
RUDI LOKITS |
K062635 |
12/19/2006 |
MODEL 2200 |
CLARIMEDEX, INC. |
JOHN DUNNING |
K060268 |
02/24/2006 |
PEDIATRIC URINARY CATHETER |
CLAY KENNARD |
CLAY KENNARD |
K052591 |
02/09/2006 |
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT |
CLINICAL DATA, INC. |
ISRAEL M STEIN |
K053260 |
02/22/2006 |
OSSIX -PLUS |
COLBAR LIFESCIENCE LTD. |
JONATHAN S KAHAN |
K063030 |
12/04/2006 |
COMFORT SCOOTER MODEL LY-EW406 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
K053561 |
02/23/2006 |
BIO-MINI REVO SUTURE ANCHOR |
CONMED LINVATEC |
ELIZABETH PAUL |
K063457 |
12/05/2006 |
TRUEHD (1080P) DIGITAL CAMERA SYSTEM |
CONMED LINVATEC |
ELIZABETH PAUL |
K052448 |
02/23/2006 |
POCKET BREATHALYZER. CONNECTABLES |
CONNECTABLES, LLC |
PHILLIP H CORSE |
K061937 |
12/01/2006 |
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON |
COOK ENDOSCOPY |
MABEL L HUNTER |
K063619 |
12/20/2006 |
FLIPPER DETACHABLE EMBOLIZATION COILS |
COOK, INC. |
LISA WEBB |
K060174 |
02/17/2006 |
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM |
COOK, INC. |
EVANGELINE D LOH |
K063254 |
12/07/2006 |
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
K052696 |
02/03/2006 |
COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING |
COVALON TECHNOLOGIES LTD. |
JACQUES LEMMETTI |
K051288 |
02/03/2006 |
VIELLE LUBRICANT |
CST MEDICAL LIMITED |
Christian Smith |
K053608 |
02/13/2006 |
CYNOSURE PHOTOGENICA V-STAR LASER |
CYNOSURE, INC. |
GEORGE CHO |
K053421 |
02/01/2006 |
YAG MIR FAMILY LASER |
CYNOSURE, INC. |
GEORGE CHO |
K053108 |
02/16/2006 |
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 |
DADE BEHRING, INC. |
YUK-TING LEWIS |
K063206 |
12/28/2006 |
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY- LYONS |
K053576 |
02/07/2006 |
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K060090 |
02/27/2006 |
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K053061 |
02/06/2006 |
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
DADE BEHRING, INC. |
YUK-TING LEWIS |
K060088 |
02/03/2006 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN |
DADE BEHRING, INC. |
ROBERT C EUSEBIO |
K063366 |
12/08/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K053504 |
02/24/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062924 |
12/26/2006 |
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK |
DADE BEHRING, INC. |
PAMELA A JURGA |
K063365 |
12/08/2006 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062710 |
12/08/2006 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
K052731 |
02/01/2006 |
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES |
DAXIN LI |
YINGCHAO XIAO |
K052823 |
02/21/2006 |
IMPLANTIUM ABUTMENTS |
DENTIUM, INC. |
KLAAS BESSELING |
K060293 |
02/17/2006 |
TEMPORARY CROWN AND BRIDGE MATERIAL |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K063478 |
12/15/2006 |
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FOSTADT |
K062426 |
12/15/2006 |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K052546 |
02/03/2006 |
AEGIS ANTERIOR LUMBAR PLATE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K062814 |
12/15/2006 |
PIPELINE II ACCESS SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K063045 |
12/05/2006 |
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN |
DIAGNOSTIC PRODUCTS CORP. |
DEBORAH L MORRIS |
K053533 |
02/03/2006 |
IMMULITE/IMMULITE 1000 TURBO INTACT PTH |
DIAGNOSTIC PRODUCTS CORPORATION |
DEBORAH L MORRIS |
K063057 |
12/22/2006 |
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP |
DIAGNOSTIC PRODUCTS CORPORATION |
DEBORAH L MORRIS |
K061805 |
12/06/2006 |
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM |
DIAGNOSTICA STAGO, INC. |
LAURA WORFOLK |
K062674 |
12/01/2006 |
MISSION TRINITY B |
DIAMOND DIAGNOSTICS, INC. |
RANDOLPH QUINN |
K052499 |
02/08/2006 |
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS |
DIASORIN S.P.A. |
MARI A MEYER |
K053566 |
02/15/2006 |
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A |
DIAZYME LABORATORIES |
HUAN TRAN |
K063482 |
12/14/2006 |
CROSSPLAN / ACCUSOFT-XL V.4.04 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K052705 |
02/21/2006 |
DART-12 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K061466 |
12/04/2006 |
INTIMOL |
DLC LABORATORIES, INC. |
JUAN MANZUR |
K062364 |
12/06/2006 |
I-SCOPE 200 |
DONGJIN MEDICAL CO., LTD |
MIN-KANG KIM |
K053204 |
02/03/2006 |
INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A |
DRAEGER MEDICAL AG & CO. KGAA |
MONICA FERRANTE |
K053484 |
02/22/2006 |
INFINITY GAMMA / GAMMAXL, INFINITY VISTA |
Draeger Medical Systems, Inc. |
KAREN A LORIO |
K060988 |
12/06/2006 |
TOTAL AND HEMI SHOULDER SYSTEM |
DVO EXTREMITY SOLUTIONS, LLC |
DINA WEISSMAN |
K063469 |
12/01/2006 |
MEDICAN ALPHA |
EASTERN MEDIKIT LTD. |
RAJEEV ASRI |
K060079 |
02/08/2006 |
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM |
EASTMAN KODAK COMPANY |
RAVI NABAR |
K060055 |
02/07/2006 |
KODAK PACS |
EASTMAN KODAK COMPANY |
CAROLYN L WAGNER |
K053609 |
02/28/2006 |
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
DIANE PETERSON |
K060084 |
02/07/2006 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K062508 |
12/05/2006 |
NEUROWAVE MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K052241 |
02/24/2006 |
DISC-FX SYSTEM |
ELLMAN INTERNATIONAL, INC. |
JOAN CARTER |
K063414 |
12/12/2006 |
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K060279 |
02/28/2006 |
CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
ALDEN KAY |
K063182 |
12/21/2006 |
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX |
ENPATH MEDICAL, INC. |
JAMES JENKINS |
K053429 |
02/08/2006 |
ADVANCED UROLOGICAL CATHETER |
ENTRACARE, LLC |
AL BOEDEKER |
K060046 |
02/27/2006 |
DERMASTREAM |
ENZYSURGE, LTD. |
GEORGE J HATTUB |
K053318 |
02/17/2006 |
RX EPIDURAL NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
K060183 |
02/16/2006 |
ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER |
ERBE USA, INC. |
JOHN TARTAL |
K060170 |
02/16/2006 |
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS |
ERBE USA, INC. |
JULIE STEPHENS |
K061533 |
12/11/2006 |
PROCEED VENTRAL PATCH |
ETHICON, INC. |
BRYAN A LISA |
K062045 |
12/04/2006 |
EDIA ANTI-CCP |
EURO-DIAGNOSTICA AB |
ANNIKA ANDERSSON |
K051489 |
02/16/2006 |
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM |
EUROIMMUN US LLC |
KATHRYN KOHL |
K052659 |
02/17/2006 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC |
GLEN D SMYTHE |
K053493 |
02/22/2006 |
BERRY FRUITY TEETHER |
EVENFLO COMPANY, INC. |
RUBEN D COLMENARES |
K063213 |
12/05/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K063214 |
12/08/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K063215 |
12/08/2006 |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K060107 |
02/06/2006 |
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS |
EXACTECH, INC. |
MARITZA ELIAS |
K050806 |
02/08/2006 |
OPTECURE |
EXACTECH, INC. |
REBECCA S ROBERTS |
K053058 |
02/07/2006 |
XLTEK NEUROPATH, MODEL PK1070 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K052192 |
02/02/2006 |
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I |
FEMSPEC L.L.C. |
CARL YOUNGMANN |
K063036 |
12/22/2006 |
OPUS HC482 DIRECT NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAYANTI KARANDIKAR |
K053139 |
02/16/2006 |
FOTONA QX ND:YAG/KTP LASER SYSTEM |
FOTONA D.D. |
STOJAN TROST |
K060144 |
02/13/2006 |
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
K051217 |
02/03/2006 |
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) |
GE HEALTHCARE |
JOEL KENT |
K062324 |
12/06/2006 |
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN |
GE HEALTHCARE |
JOEL KENT |
K063628 |
12/26/2006 |
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
KAREN M LUNDE |
K060259 |
02/22/2006 |
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
K063224 |
12/22/2006 |
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL |
GENTRIS CORPORATION |
DEBORAH N KLOOS |
K051244 |
02/21/2006 |
GENZYME OSOM INFLUENZA A & B TEST |
GENZYME CORP. |
FRED D LASKY |
K062836 |
12/19/2006 |
CITADEL ANTERIOR LUMBAR PLATE SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
K052617 |
02/23/2006 |
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
K063374 |
12/06/2006 |
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE |
Grace Medical, Inc. |
JEFF COBB |
K043178 |
02/02/2006 |
GRANTALDER RHAPSODY ACCESS PORT AND CATHETER |
GRANTADLER CORPORTATION |
MICHAEL LOITERMAN |
K052665 |
02/27/2006 |
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES |
GRANTON MEDICAL LTD. |
CYNTHIA J.M. NOLTE |
K050668 |
02/03/2006 |
GRT LITE, MODEL 8-A |
GRT SOLUTIONS, INC. |
GEORGE GONZALEZ |
K052965 |
02/13/2006 |
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. |
GUIDANT CORPORATION |
Linda Kleinsasser |
K060290 |
02/27/2006 |
SHOULDER FIXATION SYSTEM |
HAND INNOVATIONS, LLC. |
ERNESTO HERNANDEZ |
K062950 |
12/21/2006 |
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN K HON |
K062383 |
12/21/2006 |
UNISYN HA PLASMA MODULAR HIP |
HAYES MEDICAL, INC. |
LUKE ROSE |
K063612 |
12/29/2006 |
MODIFICATION TO HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH |
K052465 |
12/12/2006 |
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 |
HEARTSINE TECHNOLOGIES, INC. |
GEORGE BRDLIK |
K053253 |
02/17/2006 |
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM |
HEMOCUE AB |
ALLAN WHITE |
K061879 |
12/15/2006 |
SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM |
HEMODIAGNOSTICA, LLC |
Bruno Borganti |
K063062 |
12/01/2006 |
HKBOND 2006 |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K050516 |
02/03/2006 |
T-SLING |
HERNIAMESH S.R.L. |
LORENA TRABUCCO |
K063034 |
12/14/2006 |
AIR-FLEX WITH AUTO-DISTRACTION |
HILL LABORATORIES CO. |
BRADY ALLER |
K053148 |
02/17/2006 |
CXR16 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K063513 |
12/12/2006 |
ECHELON MR-RCC-150 CARDIAC COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS J THISTLEWAITE |
K063518 |
12/21/2006 |
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K052446 |
02/02/2006 |
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
MATTHEW S GLEI |
K052671 |
02/03/2006 |
HOCA EZ-CARE BP108, TENDER-CARE BP109 |
HOCA MEDICAL MICROSYSTEM, INC. |
JEN KE-MIN |
K052828 |
02/17/2006 |
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) |
HOSPIRA, INC. |
THOMAS KOZMA |
K063180 |
12/11/2006 |
ISECURE SYRINGE CARTRIDGE HOLDER |
HOSPIRA, INC. |
DIANE RENNPFERD |
K063239 |
12/11/2006 |
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 |
HOSPIRA, INC. |
DIANE RENNPFERD |
K063616 |
12/20/2006 |
TRIDENT II ACETABULAR SYSTEM |
HOWMEDICA OSTEONICS CORP |
MANAL MORCOS |
K063225 |
12/27/2006 |
METAIZEAU NAILING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K062845 |
12/13/2006 |
MODULAR REPLACEMENT ELBOW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
K063112 |
12/01/2006 |
REVLITE Q-SWITCHED ND:YAG LASER |
HOYA CONBIO, INC |
DONNA K TEMPLEMAN |
K053178 |
02/01/2006 |
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS |
HU-FRIEDY MFG. CO.,INC. |
KEITH DUNN |
K053618 |
02/08/2006 |
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 |
HUTCHINSON TECHNOLOGY, INC. |
JOSEPH P ORTNER |
K053575 |
02/15/2006 |
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS |
HYGIA HEALTH SERVICES, INC. |
KYLE FERGUSON |
K063166 |
12/22/2006 |
I.T.S. PELVIC RECONSTRUCTION SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
K062626 |
12/20/2006 |
CORTISOL ELISA |
IBL-HAMBURG GMBH |
VICTOR HERBST |
K052594 |
02/10/2006 |
WILLCARE, MODEL GW-1020 |
ICU MEDICAL INC |
SCOTT NELSON |
K063474 |
12/22/2006 |
ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) |
IMC-HEARTWAY, LLC |
MICHAEL CHEN |
K063392 |
12/12/2006 |
IMCO-STAT |
IMCO TECHNOLOGIES |
MARK L SCHWARTZ |
K053170 |
02/01/2006 |
PREFORMANCE POSTS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K060291 |
02/27/2006 |
PREFORMANCE TEMPORARY CYLINDER |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K062891 |
12/14/2006 |
PROTON THERAPY SYSTEM |
INDIANA UNIVERSITY CYCLOTRON FACILITY |
JONATHAN S KAHAN |
K061902 |
12/08/2006 |
COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 |
INDITHERM MEDICAL |
M.W. (ANDY) ANDERSON |
K053367 |
02/21/2006 |
MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
GOH MIAH KIAT |
K062151 |
12/22/2006 |
BOX PEEK VBR SYSTEM |
INNOVASIS, INC. |
WARREN M DANSIE |
K062707 |
12/08/2006 |
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
GERALD GOIGITZER |
K061901 |
12/14/2006 |
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS |
FREDERICK MONTGOMERY |
K062708 |
12/13/2006 |
QUANTA LITE CELIAC DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
DONNA L GUSTAFSON |
K061841 |
12/22/2006 |
QUANTA LITE INTRINSIC FACTOR ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
K053088 |
02/27/2006 |
SLACTIVE IMPLANTS |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
K060062 |
02/03/2006 |
STRAUMANN ORTHOSYSTEM |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
K060162 |
02/21/2006 |
ACL ELITE; ACL ELITE PRO |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K063020 |
12/14/2006 |
INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM |
INTAI TECHNOLOGY INC. |
PIEWEN LIN |
K062353 |
12/20/2006 |
MOZAIK BONE REGENERATION MATRIX - PUTTY |
INTEGRA LIFESCIENCES CORPORATION |
DIANA M BORDON |
K053655 |
02/03/2006 |
TENDON WRAP TENDON PROTECTOR |
INTEGRA LIFESCIENCES CORPORATION |
DIANA M BORDON |
K063230 |
12/21/2006 |
INTEGRA RADIONICS IMAGEFUSION 3 |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
K050783 |
02/22/2006 |
ISSYS DRUG FLOW MONITOR |
INTEGRATED SENSING SYSTEMS, INC. |
STEPHEN GOLDNER, JD, RAC |
K063402 |
12/11/2006 |
WICK ELECTRODE, MODEL M019260 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
K063484 |
12/22/2006 |
PATIENT DATA HANDLER & DEVICES (PDH&D) |
INTERMED ADVISORS, INC. |
CHRISTINA VULLO |
K063220 |
12/01/2006 |
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K060133 |
02/16/2006 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET |
INVERNESS MEDICAL INNOVATIONS, INC. |
JAMES M DELANEY |
K061889 |
12/12/2006 |
BIOSTAR OIA SHIGATOX |
INVERNESS MEDICAL-BIOSTAR INC. |
ROBIN C HART |
K062880 |
12/22/2006 |
SUBDERMAL WIRE ELECTRODE, MODEL SWE |
IVES EEG SOLUTIONS, INC. |
JOHN R IVES |
K062602 |
12/11/2006 |
BAND-AID(R) BRAND LIQUID BANDAGE |
JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
MICHELLE R TURK |
K053403 |
02/01/2006 |
LUCAS |
JOLIFE AB |
HOWARD HOLSTEIN |
K060080 |
02/08/2006 |
DIAGNODENT 2190 WITH PERIODONTAL PROBE |
KAVO DENTAL CORPORATION |
DANIEL KAMM |
K053627 |
02/06/2006 |
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
KCI USA, INC. |
CHRISTY H OVIATT |
K063426 |
12/13/2006 |
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 |
KCI USA, INC. |
VERONIQUE SMITH |
K060097 |
02/27/2006 |
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K052676 |
02/17/2006 |
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
K052450 |
02/28/2006 |
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
K062965 |
12/22/2006 |
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
JAMES F LOGAN |
K063640 |
12/18/2006 |
KOWA SL-15 |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
K063228 |
12/08/2006 |
SURFACE COAT |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K052347 |
02/17/2006 |
TITAN STEERABLE (PTCA) GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
K061656 |
12/15/2006 |
LASER-D68 |
LASER PAIN CLINICS LP |
HOLLY WRIGHT |
K062719 |
12/01/2006 |
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES |
LASERSCOPE |
PAUL HARDIMAN |
K061462 |
12/15/2006 |
BF+ (PH) |
LDR SPINE USA |
EDWARD E NEWTON |
K050586 |
02/27/2006 |
LEONE IMPLANT SYSTEM |
LEONE SPA |
GREG HOLLAND |
K051020 |
02/24/2006 |
ES-160 |
LHASA OMS, INC. |
MARK W SHEEHAN |
K062811 |
12/20/2006 |
DPILOG, MODEL DPC-512 |
LIFE OUTCOMES, INC. |
CHARLES M HART |
K052954 |
02/15/2006 |
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET |
LIFE-TECH, INC. |
JEFF KASOFF |
K061726 |
12/04/2006 |
LSC, MODEL 3 |
LIFESTAND |
STEFANIE D BANKSTON |
K063025 |
12/01/2006 |
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, |
LINA MEDICAL APS |
WALT BRITTLE |
K060017 |
02/23/2006 |
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
K060194 |
02/13/2006 |
MARCH HEALTHCARE HEALTH MONITORING KIT |
MARCH HEALTHCARE CORPORATION |
TIMON LEDAIN |
K063140 |
12/29/2006 |
RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
K053592 |
02/08/2006 |
SIMPLANT DR. JAMES |
MATERIALISE N.V. |
CARL VAN LIERDE |
K060210 |
02/10/2006 |
MEDIPORT |
MAXANT TECHNOLOGIES, INC. |
DONALD P DEVALE |
K053397 |
02/17/2006 |
K-Y BRAND SENSUAL MIST |
MCNEIL-PPC, INC. |
NADER FOTOUHI |
K061484 |
12/07/2006 |
MODIFICATION TO: SMITHWICK CAROTID SHUNT |
MCPHERSON ENTERPRISES, INC. |
WILLIAM MCPHERSON |
K063580 |
12/14/2006 |
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
K052833 |
02/15/2006 |
GORE-TEX NON-STERILE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
K052168 |
02/16/2006 |
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K062969 |
12/14/2006 |
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K052797 |
02/13/2006 |
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM |
MEDTEK DEVICES, INC. |
ROBERT O DEAN |
K063119 |
12/22/2006 |
LIFEPAK 20 DEFIBRILLATOR/ MONITOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
MICHELLE ACKERMANN |
K052057 |
02/17/2006 |
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
SHERRI POCOCK |
K060400 |
02/28/2006 |
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT |
MEDTRONIC INC. |
DAVID D COX |
K062821 |
12/19/2006 |
U-CLIP DEVICE |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
K060081 |
02/13/2006 |
BASIS SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K060203 |
02/13/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K060794 |
12/18/2006 |
PROGENIX DBM PUTTY AND PASTE |
MEDTRONIC SOFAMOR DANEK |
EDWARD S CHIN |
K062986 |
12/08/2006 |
MEDTRONIC GRAFT DELIVERY SYRINGE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
EDWARD S CHIN |
K062879 |
12/22/2006 |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
ED CHIN |
K060220 |
02/09/2006 |
PBS MODEL 701A COMPRESSION THERAPY DEVICE |
MEGO AFEK |
AHAVA M STEIN |
K062752 |
12/07/2006 |
MERCATOR MICROSYRINGE II INFUSION CATHETER |
MERCATOR MEDSYSTEMS, INC. |
KIRK SEWARD |
K062355 |
12/27/2006 |
ENA CEM |
MICERIUM S.P.A. |
EUGENIO MICELI |
K062367 |
12/08/2006 |
MINISCREWS ANCHORING SYSTEM, M.A.S. |
MICERIUM S.P.A. |
EUGENIO MICELI |
K063381 |
12/22/2006 |
CT COMPATIBLE F/S/D APPLICATORS |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FLEIX MICK |
K063382 |
12/26/2006 |
HDR CT COMPATIBLE SPLIT RING APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
K061283 |
12/14/2006 |
PULMOLIFE |
MICRO MEDICAL, LTD. |
GLEN HILLSLEY |
K053411 |
02/03/2006 |
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS |
MICROGENICS CORP. |
TONY C LAM |
K062867 |
12/06/2006 |
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
K061615 |
12/22/2006 |
INTERDRY TEXTILE WITH SILVER |
MILLIKEN CHEMICAL |
MARY MCNAMARA-CULLINANE |
K061033 |
12/12/2006 |
MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) |
MILTEX, INC. |
CHARLES WEAVER |
K053216 |
02/10/2006 |
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
K062524 |
12/15/2006 |
OCTAX LASER SHOT SYSTEM |
MINITUBE OF AMERICA, INC |
FREDERICK KIKKERS |
K061875 |
12/11/2006 |
MINISPIR; SPIROLAB III |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K061712 |
12/01/2006 |
SPIROBANK II |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
K062847 |
12/20/2006 |
BIOGEL ECLIPSE INDICATOR UNDERGLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
STEVEN DOWDLEY |
K060852 |
12/26/2006 |
MOONCUP |
MOONCUP LIMITED |
SU HARDY |
K053361 |
02/06/2006 |
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
K053218 |
12/28/2006 |
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
K061774 |
12/13/2006 |
NFIX II PEDICLE SCREW SYSTEM |
N SPINE, INC. |
R. STEPHEN REITZLER |
K062539 |
12/01/2006 |
NCONTACT COAGULATION SYSTEM KIT |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K063012 |
12/01/2006 |
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K062533 |
12/22/2006 |
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 |
NEUROVIRTUAL USA, INC. |
EDUARDO FARIA |
K063095 |
12/22/2006 |
HUMERUS LOCKING PLATING SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
K063221 |
12/12/2006 |
MEDWEB ADVANCED 3D WEB PACS |
NEXSYS ELECTRONICS, INC. |
GARY J ALLSEBROOK |
K062551 |
12/15/2006 |
NEXUS IRRIGATION TUBING SET |
NEXUS MEDICAL, LLC |
ANITA SMITH |
K062115 |
12/27/2006 |
CARBON DIOXIDE MONITOR, MODEL OLG-2800A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K060034 |
02/28/2006 |
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE |
NIPRO MEDICAL CORPORATION |
KAELYN B HADLEY |
K062936 |
12/19/2006 |
NOBELPERFECT CONICAL CONNECTION |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K053050 |
02/22/2006 |
PROCERA BRIDGE ALUMINA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K053068 |
02/22/2006 |
PROCERA BRIDGE LAMINATE, MODEL 40-4002 |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K053125 |
02/22/2006 |
PROCERA BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K053602 |
02/10/2006 |
PROCERA SOFTWARE, MODEL 33145 |
NOBEL BIOCARE AB |
HERBERT CRANE |
K062566 |
12/06/2006 |
NOBELREPLACE TAPERED CONICAL CONNECTION |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
K063274 |
12/12/2006 |
ACCULOC BREAST LOCALIZATION SYSTEM |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
LEE MYERS |
K053387 |
02/14/2006 |
PERIOGLAS BONE GRAFT PARTICULATE |
NovaBone Products, LLC |
DAVID M GAISSER |
K063153 |
12/07/2006 |
NOVAPACS |
NOVARAD CORP. |
PAUL SHUMWAY |
K053581 |
02/17/2006 |
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K060113 |
02/22/2006 |
DERMACYN WOUND CARE |
OCULUS INNOVATIVE SCIENCES, INC. |
TAMMY ATWOOD |
K062517 |
12/22/2006 |
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K062760 |
12/11/2006 |
ORI F6T DRY ECG MONITORING ELECTRODE |
ORBITAL RESEARCH INC. |
AARON ROOD |
K062856 |
12/13/2006 |
TF ROTARY NICKEL TITANIUM FILE |
ORMCO CORP. |
COLLEEN BOSWELL |
K053293 |
02/16/2006 |
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
K062838 |
12/19/2006 |
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 |
ORTHO-CLINICAL DIAGNOSTICS |
CHARLOTTE BAKER |
K062285 |
12/22/2006 |
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
K063591 |
12/15/2006 |
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K062460 |
12/15/2006 |
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K063164 |
12/28/2006 |
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K063143 |
12/26/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
CHARLOTTE BAKER |
K053182 |
02/27/2006 |
DRLOCK DISTAL RADIUS VOLAR SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
EDWARD A KROLL |
K063395 |
12/22/2006 |
O&P BIVALVE CRANIAL MOLDING HELMET |
ORTHOTIC & PROSTHETIC LAB, INC. |
THOMAS L MALONE |
K062502 |
12/15/2006 |
OSSPRAY CLEANING COMPOUND |
OSPRAY, LTD. |
CARMELINA G ALLIS |
K053374 |
02/21/2006 |
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) |
OSSACUR AG |
KRISTI KISTNER |
K060839 |
12/07/2006 |
ABC HAIR REMOVAL SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
K061436 |
12/06/2006 |
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
SHARON L TIMBERLAKE |
K052983 |
02/10/2006 |
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K062518 |
12/04/2006 |
CELERITY |
PARKELL, INC. |
NELSON J GENDUSA |
K043587 |
02/03/2006 |
SUCRALFATE AND CARAFATE PASTE KITS |
PATRICK D. MCGRATH PH.D |
PATRICK D MCGRATH |
K061350 |
12/22/2006 |
LITHODIAMOND ULTRA |
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
JONATHAN KAHAN |
K062947 |
12/14/2006 |
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES |
PENG LIM ENTERPRISE CO., LTD. |
Ke-Min Jen |
K052298 |
12/12/2006 |
CYSTOGLIDE INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
K062796 |
12/08/2006 |
K-Y BRAND INTRIGUE |
PERSONAL PRODUCTS CO. |
NADER FOTOUHI |
K062787 |
12/29/2006 |
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
MARTIN R MANN |
K062583 |
12/26/2006 |
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
MARTIN R MANN |
K052793 |
02/07/2006 |
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 |
PHARMACIA DIAGNOSTICS AB |
MARTIN R MANN |
K060221 |
02/17/2006 |
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HERBERT VAN DYK |
K060792 |
12/01/2006 |
ILLUMIMED |
PHOTOACTIF, LLC |
JEREMY SHELLMAN |
K063009 |
12/27/2006 |
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) |
PRAESIDIA S.R.L. |
GEORGE HAAR |
K053657 |
02/13/2006 |
POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE |
PT. MAHAKARYA INTI BUANA |
P. SASITHARAN NAIR |
K062709 |
12/06/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, BLACK |
PT. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
K052281 |
02/08/2006 |
EMBRACE WETBOND CLEAR SEALANT |
PULPDENT CORPORATION |
KENNETH J BERK |
K052858 |
02/09/2006 |
SOOTHIES GEL PADS |
PURONXY, INC. |
LESLIE SEBASTAIN |
K062929 |
12/18/2006 |
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA |
QUEST DIAGNOSTICS, INC. |
LIUMING YU |
K062769 |
12/04/2006 |
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K052991 |
02/01/2006 |
RADIANCY FACIAL SKINCARE DEVICE |
RADIANCY (ISRAEL) LTD. |
MARGARET FOURTE |
K063229 |
12/19/2006 |
REST ASSURED NITE PROTECTOR |
RANIR LLC |
CHRISTOPHER PREDKO |
K053212 |
02/15/2006 |
RAVEN PROPACT |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
K062612 |
12/13/2006 |
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 |
RAYNER SURGICAL INC |
MARK MULLANEY |
K060253 |
02/23/2006 |
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. |
REGENERATION TECHNOLOGIES, INC. |
Lisa Simpson |
K053443 |
02/01/2006 |
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
K063750 |
12/20/2006 |
XCEL 255 SLIT LAMP |
REICHERT INC. |
SANDRA BROWN |
K053205 |
02/03/2006 |
RES TRAXX DATA CENTER |
RESMED LTD. |
DAVID D'CRUZ |
K053352 |
02/15/2006 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
ZITA A YURKO |
K051097 |
02/24/2006 |
GERATHERM SOS-RESCUE BLANKET |
RG ENT., INC. |
RONALD G LETOURNEAU |
K061737 |
12/18/2006 |
LOSS OF RESISTANCE SYRINGE |
ROBERT BUSSE & CO., INC. |
MUHAMAD ANSARI |
K053603 |
02/09/2006 |
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K063543 |
12/22/2006 |
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K060108 |
02/16/2006 |
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
K053426 |
02/07/2006 |
ROCHE ELECSYS ANTI-TG |
ROCHE DIAGNOSTICS CORP. |
RANDY JOHNSON |
K053006 |
02/03/2006 |
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II |
ROSSMAX INTERNATIONL LTD. |
YOLANDA LIN |
K062001 |
12/07/2006 |
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K063497 |
12/19/2006 |
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
RALPH ZIMMERMAN |
K063499 |
12/19/2006 |
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
RALPH ZIMMERMAN |
K060348 |
02/27/2006 |
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
K053558 |
02/17/2006 |
CEPH, MODEL 4900 |
SCHICK TECHNOLOGIES, INC. |
DANIEL MICHAELI |
K053412 |
02/23/2006 |
FLEXISCOPE, MODELS 50MH AND 50 MHC |
SCHOELLY IMAGING, INC. |
PAMELA PAPINEAU |
K052509 |
12/11/2006 |
M-BOLUS EMBOLIC MICROSPHERES |
SCION CARDIO-VASCULAR, INC. |
SUZANA OTANO-LATA |
K060033 |
02/28/2006 |
PROFILE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
K051699 |
02/06/2006 |
SEJOY, MODEL MT-403 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
JIANYAO WU |
K063334 |
12/08/2006 |
SHANGHAI GANGHAI MODEL GIKO 1400 |
SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. |
JOSEPH Z ZDROK |
K062676 |
12/14/2006 |
RUIKE, MODEL 3331 |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
K062645 |
12/19/2006 |
RUIKE, MODEL 3431 |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
K052162 |
02/06/2006 |
SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT |
SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC |
KATHLEEN HACKU |
K063500 |
12/06/2006 |
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN GOLDSTEIN-FALK |
K063055 |
12/21/2006 |
VS-800 VITAL SIGNS MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K053523 |
02/14/2006 |
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
MICKY LIN |
K060060 |
02/03/2006 |
BIOGRAPH 6 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
M. ALAINE MEDIO |
K060179 |
02/08/2006 |
BIO-RAY SDX DIGITAL X-RAY SYSTEM |
SIGMA BIOMEDICS, INC. |
KIM ANTOL |
K061082 |
12/18/2006 |
MOBIS SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K063160 |
12/22/2006 |
ALLERGEAZE PATCH TEST CHAMBERS |
SMART PRACTICE |
KIM SULLIVAN |
K053344 |
02/23/2006 |
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
K060123 |
02/14/2006 |
LEVELERT II FLUID LEVEL SENSOR |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K063253 |
12/12/2006 |
RCHIVE PACS |
SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD |
CARL ALLETTO |
K063459 |
12/26/2006 |
CRANEX NOVUS |
SOREDEX PALODEX GROUP OY |
KAI LANER |
K063136 |
12/19/2006 |
NEEDLELESS SLING |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
K061578 |
12/26/2006 |
SSP VERTEBRAL BODY REPLACEMENT |
SPECIALTY SPINE PRODUCTS, LLC |
FLOYD G LARSON |
K062513 |
12/22/2006 |
APEX SPINE SYSTEM |
SPINECRAFT, INC. |
AMI AKALLAL-ASAAD |
K062435 |
12/05/2006 |
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS |
SPIRE BIOMEDICAL, INC. |
SHEKHAR NIMKAR |
K053277 |
02/24/2006 |
CPS DIRECT SL OUTER CATHETER |
ST. JUDE MEDICAL |
DEANNA HUGHES |
K062333 |
12/14/2006 |
LAIMAD |
STEVEN LAMBERG, D.D.S |
JONATHAN S KAHAN |
K060795 |
12/18/2006 |
SOMNOFIT |
STRATEGIC COUNSEL SARL |
JOHN DENNIS |
K063218 |
12/14/2006 |
E-CHECK (XE) |
Streck |
KERRIE OETTER |
K060083 |
02/09/2006 |
NRBC-CHEX FOR LH |
Streck |
KERRIE OETTER |
K062640 |
12/14/2006 |
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 |
STRYKER INSTRUMENTS |
BECKEY DITTY |
K063428 |
12/11/2006 |
XIA STAINLESS STEEL SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K050956 |
02/16/2006 |
TBR IDEA CONIC/CONIC |
SUDIMPLANT SA |
DIDIER SAILHAN |
K063600 |
12/19/2006 |
VISTA AVS |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
K060149 |
02/03/2006 |
SUNIPAN IMAGING SYSTEM & ACCESSORIES |
SUNI MEDICAL IMAGING, INC. |
F. A BETTENCOURT |
K053240 |
02/03/2006 |
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
K063485 |
12/01/2006 |
LOGIC LAPAROSCOPIC SCISSORS |
SURGICAL INNOVATIONS PLC |
STUART MORAN |
K062265 |
12/26/2006 |
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM |
SWISS MEDICAL CARE S.A. |
ROBERT AROMANDO |
K063116 |
12/05/2006 |
DEMETRON A.2 |
SYBRON DENTAL SPECIALTIES |
COLLEEN BOSWELL |
K053565 |
02/03/2006 |
TEMPBOND CLEAR WITH TRICLOSAN |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K062915 |
12/06/2006 |
VERITAS COLLAGEN MATRIX |
SYNOVIS SURGICAL INNOVATIONS |
CYNTHIA LAMARUCCIOLA |
K063049 |
12/18/2006 |
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM |
SYNTHES (USA) |
DEBORAH L JACKSON |
K053508 |
02/13/2006 |
SYNFIX-LR |
SYNTHES SPINE CO.LP |
ANGELA MIKROULIS |
K062652 |
12/28/2006 |
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR |
TANITA CORPORATION OF AMERICA |
BETH MACKEY |
K051137 |
02/24/2006 |
TECHDEVICE OCCLUSION BALLOON CATHETER |
TECHDEVICE CORPORATION |
LEIGH HAYWARD |
K063613 |
12/26/2006 |
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K061227 |
12/20/2006 |
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
THE HYMED GROUP CORP. |
ANITA PETITO |
K060851 |
12/22/2006 |
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER |
THE SMITHWORKS COMPANY |
PATRICIA A MILBANK |
K060176 |
02/07/2006 |
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
K052882 |
02/15/2006 |
FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERLIE |
K053378 |
02/23/2006 |
LOOP RECORDER VITAPHONE, 3100 SERIES |
TMS TELEMEDIZINISCHE SYSTEME GMBH |
TILO BORCHARDT |
K063551 |
12/22/2006 |
AEQUALIS HUMERAL PLATE |
TORNIER |
Mireille Lemery |
K062661 |
12/22/2006 |
AEQUALIS RESURFACING HEAD |
TORNIER |
Mireille Lemery |
K063200 |
12/07/2006 |
20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K063199 |
12/04/2006 |
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K062841 |
12/20/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K051931 |
02/17/2006 |
AXCEL |
TRI DENTAL INNOVATORS |
LINDA NGUYEN |
K060041 |
02/07/2006 |
TRIMED BONE PLATES |
TRIMED, INC. |
KELLI ANDERSON |
K053605 |
02/27/2006 |
AEROECLIPSE II BREATH ACTUATED NEBULIZER |
TRUDELL MEDICAL INTL. |
JOHN STRAATMAN |
K053625 |
02/22/2006 |
NASALGUARD |
TRUTEK CORP |
ASHOK WAHL |
K062577 |
12/15/2006 |
V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC |
TZ MEDICAL, INC. |
MADALYN DUNCAN |
K052204 |
02/15/2006 |
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER |
TZORA ACTIVE SYSTEMS LTD. |
ALEX GONOROVSKY |
K063416 |
12/07/2006 |
LUXVISION SLIT LAMP |
U.S. OPHTHALMIC LLC |
AL WEISENBORN |
K060416 |
12/26/2006 |
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE |
ULRICH GMBH & CO. KG |
IAN P GORDON |
K063703 |
12/21/2006 |
CITRIC ACID 20% SOLUTION, MODEL 329 |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
K060335 |
02/24/2006 |
FILE-EZE |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
K060334 |
02/23/2006 |
GI DENTSTAT |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
K063557 |
12/12/2006 |
PEAK BOND, MODEL 5133 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K063558 |
12/14/2006 |
PEAK SE, MODEL 5135 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K062791 |
12/11/2006 |
USI DENTAL SCALER, 25XXX SERIES |
ULTRASONIC SERVICES INC. |
JAMES FEINE |
K060346 |
12/22/2006 |
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM |
ULTRAZONIX DNT AB |
JEFFREY R SHIDEMAN |
K062788 |
12/28/2006 |
COLLIMATOR, MODEL M-38 |
UMI INTERNATIONAL |
KWANG C JUNG |
K061676 |
12/27/2006 |
RIGIDOMETER, MODEL DIR-4U |
UROAN 21 |
ANABEL ROSSELLO |
K062785 |
12/26/2006 |
LTD POLYAXIAL FIXATION SYSTEM |
US SPINE |
RICHARD JANSEN |
K061276 |
12/06/2006 |
G-PROX ENDOSCOPIC GRASPER |
USGI MEDICAL |
MARY LOU MOONEY |
K052796 |
02/03/2006 |
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES |
VALLEYLAB |
ROBERT C MOORE |
K063270 |
12/14/2006 |
RPM RESPIRATORY GATING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K063371 |
12/14/2006 |
PRONTO V3 EXTRACTION CATHETER, MODEL 5003 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K053644 |
02/09/2006 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
K060142 |
02/07/2006 |
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS |
VASCUTEK LTD. |
KAREN KELSO |
K062013 |
12/14/2006 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
K062956 |
12/05/2006 |
EZ-MIO, EZ-IO DISTAL TIBIA |
VIDACARE CORPORATION |
GRACE HOLLAND |
K063142 |
12/08/2006 |
MANUAL PD-IO; POWERED PD-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
K063262 |
12/26/2006 |
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
VIRTUAL IMAGING |
DANIEL KAMM |
K062555 |
12/27/2006 |
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G |
VISGENEER, INC. |
Ke-Min Jen |
K042114 |
02/03/2006 |
MDL SERIES DIODE LASERS, MODEL MDL-10/15 |
VISION LASERTECHNIK, GMBH |
ROBERT S HEAD |
K053183 |
02/16/2006 |
JIVE X SOFTWARE |
VISUS TECHNOLOGY TRANSFER GMBH |
STEPHEN NEUSHUL |
K063337 |
12/12/2006 |
OPAL-RAD |
VIZTEK, INC. |
CARL ALLETTO |
K062345 |
12/15/2006 |
CERAMIC BOND |
VOCO GMBH |
MICHAEL SUES |
K053391 |
02/15/2006 |
X-TRA FIL |
VOCO GMBH |
MICHAEL SUS |
K062380 |
12/14/2006 |
FLOSIMPLE ARTHROSCOPY PUMP A120 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
K062940 |
12/22/2006 |
BONE INJECTION GUN (B.I.G.) |
WAISMED LTD. |
JONATHAN S KAHAN |
K053364 |
02/23/2006 |
HALUX IRIS EXAMINATION AND SURGICAL LAMP |
WALDMANN LIGHTING |
DANIEL KAMM |
K063506 |
12/18/2006 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K062842 |
12/04/2006 |
TWIST DRILL |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K053604 |
02/22/2006 |
WAVELIGHT IDAS |
WAVELIGHT LASER TECHNOLOGIE AG |
THORSTEN CRETER |
K063419 |
12/04/2006 |
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) |
WELCH ALLYN PROTOCOL, INC. |
JEFFREY WAGNER |
K060211 |
02/10/2006 |
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE |
WENZHOU WUZHOU GROUP CO. LTD. |
GEORGE SU |
K051295 |
02/15/2006 |
I-D GLIDE |
WESTRIDGE LABORATORIES INC. |
YOLANDA SMITH |
K063547 |
12/21/2006 |
CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM |
WITT BIOMEDICAL CORP |
JAMES LUKER |
K051961 |
02/10/2006 |
WWMED, MODEL 401 |
WONG WAY CORPORATION |
RICHARD KEEN |
K062960 |
12/01/2006 |
CONSERVE FEMORAL RESURFACING COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K061844 |
12/06/2006 |
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K060011 |
02/27/2006 |
MIIG SR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRIAN J YOUNG |
K060095 |
02/10/2006 |
MODIFICATION TO: VACLOK SYRINGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K062038 |
12/19/2006 |
X-STEN MILD TOOL KIT, MODEL MTK-0001 |
X-STEN CORP. |
TIMOTHY M REEVES |
K063657 |
12/12/2006 |
VASCUTRAK PTA DILATION CATHETER |
YMED INC. |
THOMAS SCHROEDER |
K060395 |
02/24/2006 |
CRYO, MODEL V6.0 |
ZIMMER ELEKTROMEDIZIN GMBH |
ARMIN PETRASCHKA |
K053340 |
02/27/2006 |
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS |
ZIMMER TRABECULAR |
MARCI HALEVI |
K061461 |
12/20/2006 |
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 |
ZIMMER, INC. |
PATRICIA JENKS |
K052321 |
02/15/2006 |
VERSYS EPOCH FULLCOAT HIP PROSTHESIS |
ZIMMER, INC. |
BRANDON HIPSHER |
K063602 |
12/21/2006 |
AUTOPULSE RESUSCITATION SYSTEM MODEL100 |
ZOLL CIRCULATION |
MARK PERKINS |
K062177 |
12/13/2006 |
ZOLL E SERIES WITH REAL CPR HELP |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |