| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K073523 |
12/14/2007 |
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K073395 |
12/05/2007 |
GILB-2, GLASS IONOMER PROTECTIVE COATING |
3M ESPE DENTAL PRODUCTS |
KAREN O'MALLEY |
| K073645 |
12/26/2007 |
SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM |
659543 BC LTD. |
HAROLD BERGMAN |
| K070428 |
02/16/2007 |
MEDICOM SELF-SEALING STERILIZATION POUCH |
A.R. MEDICOM, INC. |
JASON LUDVIG |
| K073530 |
12/19/2007 |
ACCIN ANTERIOR CERVICAL PLATE SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K073531 |
12/17/2007 |
ACCIN PEDICLE SCREW SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K070296 |
02/06/2007 |
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM |
ACE VISION GROUP |
IAN GORDON |
| K070333 |
02/07/2007 |
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL |
ACRYMED, INC. |
BRUCE GIBBONS |
| K070396 |
02/14/2007 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 |
ACUMEN MEDICAL, INC. |
MARYBETH GAMBER |
| K070490 |
02/20/2007 |
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) |
ADVANCED CIRCULATORY SYSTEMS, INC. |
PAUL DRYDEN |
| K070444 |
02/15/2007 |
AOS TIBIAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K073719 |
12/31/2007 |
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
MARY MCNAMARA-CULLINANE |
| K073471 |
12/11/2007 |
VANTAGECATH INTRAVASCULAR CATHETER |
ADVANTAGE MEDICAL DEVICE |
JAMES SMITH |
| K070178 |
02/07/2007 |
AESCULAP RESORBABLE PIN, MODEL FR735 |
AESCULAP IMPLANT SYSTEM, INC. |
MATTHEW M HULL |
| K073573 |
12/20/2007 |
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM |
AGAMATRIX |
CONNIE HERTEL |
| K070460 |
02/16/2007 |
ALLEZ SPINE CROSS CONNECTORS |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K070476 |
02/20/2007 |
REVOLIX 120 |
ALLMED SYSTEMS INC. |
PETER ALLEN |
| K070466 |
02/16/2007 |
REVOLIX DUO LASER SYSTEM |
ALLMED SYSTEMS INC. |
PETER ALLEN |
| K070514 |
02/22/2007 |
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO |
ALN IMPLANTS CHIRURGICAUX |
DAVE PARENTE |
| K073553 |
12/18/2007 |
CAMLOG IMPLANT SYSTEM ABUTMENTS |
ALTATEC GMBH |
LINDA K SCHULZ |
| K073716 |
12/31/2007 |
LIFE+CEL OR LIFECEL BATTERY |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEX HENDERSON |
| K073505 |
12/13/2007 |
MODIFICATION TO VALEO VBR |
AMEDICA CORP. |
ADAM HERDER |
| K073430 |
12/06/2007 |
VALEO PEDICLE SCREW SPINAL SYSTEM |
AMEDICA CORP. |
JUSTIN EGGLETON |
| K070342 |
02/06/2007 |
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 |
AMERICAN I.V. PRODUCTS, INC. |
JOHN TAYLOR |
| K073703 |
12/31/2007 |
AMS MINIARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
BRAD ONSTAD |
| K073526 |
12/17/2007 |
AMICAS VISION SERIES PACS, MODEL 5.5 |
AMICAS, INC. |
PATRICE NEDELEC |
| K070411 |
02/14/2007 |
AMSURE NEBULIZER |
AMSINO INTERNATIONAL, INC. |
CHING C SEAH |
| K073547 |
12/18/2007 |
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL |
ANACAPA TECHNOLOGIES, INC. |
ILA DOSHI |
| K070378 |
02/08/2007 |
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K073464 |
12/10/2007 |
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K073672 |
12/27/2007 |
SKATER BILIARY CATHETER |
ANGIOTECH |
TRUDY ESTRIDGE |
| K073520 |
12/14/2007 |
ANGIOTECH CVC |
ANGIOTECH PHARMACEUTICALS, INC. |
TRUDY D ESTRIDGE |
| K073677 |
12/28/2007 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
JEFF RYBERG |
| K073648 |
12/26/2007 |
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEN |
| K070373 |
02/08/2007 |
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W |
APOZA ENTERPRISE CO. LTD. |
JENNIFER REICH |
| K073452 |
12/14/2007 |
MODIFICATION TO: ARAGON SURGICAL LAPCAP |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K070426 |
02/13/2007 |
SILHOUETTE, MODEL 1000.01 |
ARANZ MEDICAL LIMITED |
SHANE GOODWIN |
| K073446 |
12/11/2007 |
GRIND GUARD |
ARCHTEK, INC. |
IAN P GORDON |
| K073632 |
12/26/2007 |
INTUITION, MODEL 0170 |
ARCOMA AB |
BENGT-HUGO JOHANSSON |
| K070384 |
02/09/2007 |
ARGON CONTINUOUS FLUSH DEVICE |
ARGON MEDICAL DEVICES INC. |
AMY WINDHAM |
| K073416 |
12/03/2007 |
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM |
ARKRAY FACTORY USA, INC. |
TOM SPEIKERS |
| K073451 |
12/11/2007 |
PRESSURE INJECTABLE PICC |
ARROW INTERNATIONAL, INC. |
KEVIN LENTZ |
| K070374 |
02/08/2007 |
ARTHROCARE ENT PLASMA WAND |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K073410 |
12/04/2007 |
SAVE RESUSCITATOR |
ARTIVENT CORPORATION |
GRACE HOLLAND |
| K070572 |
02/28/2007 |
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM |
ASH ACCESS TECHNOLOGY, INC. |
ROLAND WINGER |
| K073540 |
12/18/2007 |
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K073605 |
12/21/2007 |
ATRICURE COOLRAIL LINEAR PEN |
ATRICURE, INC. |
ALISON GRIMALDI |
| K073425 |
12/03/2007 |
MODIFICATION TO AURORA MRI SYSTEM |
AURORA IMAGING TECHNOLOGY, INC. |
MICHAEL A DOUGLAS |
| K070330 |
02/06/2007 |
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
SCOTT RUTHERFORD |
| K073640 |
12/26/2007 |
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
CLAIRE DORA |
| K073396 |
12/03/2007 |
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG |
B. BRAUN MEDICAL, INC. |
REBECCA STOLARICK |
| K073538 |
12/17/2007 |
DUAL CHAMBER TPN CONTAINER |
B. BRAUN MEDICAL, INC. |
TRACY MADDOCK |
| K070533 |
02/26/2007 |
BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
;EYRE Z HERNANDO |
| K070509 |
02/22/2007 |
FISSO HOLDING SYSTEM |
BAITELLA AG |
ANGELIKA SCHERP |
| K073184 |
12/20/2007 |
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K073571 |
12/20/2007 |
TRICOS T RESORBABLE BONE SUBSTITUTE |
BAXTER HEALTHCARE CORPORATION |
BARBARA K BARBEAU |
| K070440 |
02/16/2007 |
BD HYPOINT NEEDLE |
BECTON DICKINSON & CO. |
AILEEN C GILBERT |
| K073589 |
12/20/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS |
BECTON, DICKINSON & CO. |
MONICA GIGUERE |
| K073433 |
12/06/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K073262 |
12/04/2007 |
BELLA |
BEEKLEY CORP. |
MARTINE M BOUTTE |
| K070371 |
02/08/2007 |
FINGERTIP PULSE OXIMETER MD300C |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
DIANA HONG |
| K070293 |
02/07/2007 |
BENVENUE VCF OSTEO COIL SYSTEM |
BENVENUE MEDICAL, INC. |
LAURENT SCHALLER |
| K073438 |
12/07/2007 |
PROSTIM 1000/2000 |
BIO PROTECH, INC. |
E.J. SMITH |
| K070361 |
02/07/2007 |
MRSASELECT |
BIO-RAD |
FRAN WHITE |
| K070546 |
02/26/2007 |
LYPHOCHEK DIABETES CONTROL |
BIO-RAD LABORATORIES |
ELIZABETH PLATT |
| K070452 |
02/16/2007 |
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU |
BIO-RAD LABORATORIES, INC. |
JACKIE H BUCKLEY |
| K073663 |
12/26/2007 |
GELSPRAY WOUND DRESSING |
BIOCURE, INC. |
JOHN GREENBAUM |
| K070520 |
02/23/2007 |
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) |
BIOLIFE, LLC |
KAREN O'TOOLE |
| K073406 |
12/04/2007 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
NANCY WEAVER |
| K073637 |
12/26/2007 |
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
| K070399 |
02/12/2007 |
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES |
BIOMET MANUFACTURING, INC. |
TRACY B JOHNSON |
| K070389 |
02/09/2007 |
PEEK KNOTLESS ANCHORS |
BIOMET SPORTS MEDICINE, INC. |
SUSAN ALEXANDER |
| K070364 |
02/07/2007 |
100KGY E-POLY MAXROM ACETABULAR LINERS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K070369 |
02/08/2007 |
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS |
BIOMET, INC. |
ROBERT FRIDDLE |
| K070242 |
02/09/2007 |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 |
BIOSENSE WEBSTER, INC. |
NEELU MEDHEKAR |
| K073434 |
12/06/2007 |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
BIPORE, INC. |
KEITH PALUCH |
| K073420 |
12/11/2007 |
BLACKSTONE ASCENT MULTIAXIAL SCREWS |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K073654 |
12/26/2007 |
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K073713 |
12/31/2007 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
MICHELE VOVOLKA |
| K073623 |
12/26/2007 |
ATLANTIS 018 PERIPHERAL IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
EMILLY TOJIMA |
| K070310 |
02/01/2007 |
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM |
BRAHMS AKTIENGESELLSCHAFT |
JONAS LEICHTNER |
| K073615 |
12/26/2007 |
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED |
BRAINLAB AG |
PER PERSSON |
| K070106 |
02/05/2007 |
VV FLUORO 3D |
BRAINLAB AG |
RAINER BIRKENBACH |
| K070402 |
02/27/2007 |
MODIFICATION TO POLAR CARE 500 |
BREG, INC. |
KATHLEEN BARBER |
| K073458 |
12/28/2007 |
BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) |
BTLOCK SRL |
ESTER BATTILANA |
| K070465 |
02/16/2007 |
BUSSE EPIDURAL CATHETER |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K070324 |
02/05/2007 |
IPC-BOOT |
C-BOOT LTD. |
AVI ABRAHAM |
| K073598 |
12/21/2007 |
BARD DIGNICARE STOOL MANAGEMENT SYSTEM |
C.R. BARD, INC. |
MICHELLE GUDITH |
| K070508 |
02/22/2007 |
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR |
C.R. BARD, INC. |
MICHELLE GUDITH |
| K070558 |
02/27/2007 |
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS |
C.R. BARD, INC. |
SKIP RIMER |
| K073423 |
12/05/2007 |
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER |
C.R. BARD, INC. |
SUSAN D SCOTT |
| K073472 |
12/11/2007 |
VACCESS PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
JENNIFER LOGVIN |
| K073686 |
12/28/2007 |
C.T.M. POWER CHAIR, MODEL HS-1500 |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA J BOVARD |
| K070524 |
02/23/2007 |
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| K073534 |
12/17/2007 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS |
CANDELA CORP. |
LISA LACROIX |
| K070413 |
02/13/2007 |
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K070436 |
02/15/2007 |
BIOMARC GOLD TISSUE MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K070496 |
02/26/2007 |
ADVACOAT SINUS GEL AND STENT |
CARBYLAN BIOSURGERY |
ROXANNE DUBOIS |
| K070548 |
02/27/2007 |
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
TIFFINI LALUDE |
| K070380 |
02/08/2007 |
PORTACLAMP FLEX |
CARDIO LIFE RESEARCH, S.A. |
WILLIAM GREENROSE |
| K070448 |
02/15/2007 |
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 |
CARDIOMEMS INC |
GRACE POWERS |
| K070485 |
02/20/2007 |
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L |
CARDIVA MEDICAL, INC. |
MICHAEL J BILLIG |
| K073539 |
12/17/2007 |
PROVISA CEM |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K073426 |
12/05/2007 |
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K073417 |
12/04/2007 |
EMBOZENE MICROSPHERES |
CELONOVA BIOSCIENCES, INC. |
THOMAS A GORDY |
| K070462 |
02/16/2007 |
XPERT MRSA |
CEPHEID |
RUSSEL K ENNS |
| K070394 |
02/09/2007 |
CERNER PROVISION WORKSTATION |
CERNER CORP. |
SHELLEY S LOOBY |
| K070425 |
02/13/2007 |
VITALSTIM EXPERIA |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| K070512 |
02/22/2007 |
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
| K073669 |
12/26/2007 |
ORIA NATURA SPACER |
CHOICE SPINE, LP |
KAREN E WARDEN |
| K073459 |
12/10/2007 |
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K070339 |
02/07/2007 |
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES |
CINCINNATI SUB-ZERO PRODUCTS, INC |
DAN WITTMER |
| K070521 |
02/23/2007 |
MODIFIED MERCY RETRIEVER, MODEL 90070 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K070376 |
02/08/2007 |
CONMED LINVATEC 300W XENON LIGHT SOURCE |
CONMED LINVATEC |
ELIZABETH M PAUL |
| K073481 |
12/11/2007 |
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES |
CONMED LINVATEC |
JOY LOVETT |
| K073454 |
12/10/2007 |
FINGERTIP PULSE OXIMETER, MODEL CMS-50C |
CONTEC MEDICAL SYSTEM CO., LTD. |
DIANA HONG |
| K073475 |
12/18/2007 |
SYSTEM PLUS |
CONTINENTAL DENTAL LABORATORY |
KAREEN CHAMBERLAIN |
| K070405 |
02/12/2007 |
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT |
COOK BIOTECH, INC. |
DANIEL J DILLON |
| K073391 |
12/04/2007 |
SURGISIS BIODESIGN TISSUE GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN |
| K073528 |
12/17/2007 |
VENA CAVA FILTER |
COOK INCORPORATED |
MOLLY BUSENBANK |
| K073496 |
12/12/2007 |
OPTILITE HOLMIUM LASER FIBERS |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K073378 |
12/03/2007 |
ADVANCE 18LP PTA DILATATION CATHETER |
COOK, INC. |
NATHAN SIMON |
| K070410 |
02/13/2007 |
COOK MICROWIRE WIRE GUIDE |
COOK, INC. |
KAREN BRADBURN |
| K073627 |
12/26/2007 |
FLEXOR EVAC ASPIRATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K070515 |
02/22/2007 |
A-VIEW BASIC AND PLUS |
CORDATEC N.V. |
BARBARA DEBIASE |
| K073440 |
12/07/2007 |
FOUNDATION CAGE |
CORELINK LLC |
J.D. WEBB |
| K073557 |
12/19/2007 |
EEG NEUROAMP, MODEL CS10137 |
CORSCIENCE GMBH & CO. KG |
CHRISTINE BAUMANN |
| K070357 |
02/07/2007 |
FLEXCATH STEERABLE SHEATH & DILATOR |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
| K070464 |
02/16/2007 |
ONDEMAND3D |
CYBERMED, INC. |
SONG N CHOI |
| K073394 |
12/03/2007 |
SMARTLIPO LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K070346 |
02/06/2007 |
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K073604 |
12/21/2007 |
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD |
DADE BEHRING, INC. |
YUK-TING LEWIS |
| K070552 |
02/27/2007 |
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K073561 |
12/19/2007 |
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR |
DADE BEHRING, INC. |
HELEN M LEE |
| K073701 |
12/31/2007 |
DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 |
DANE TECHNOLOGIES |
OLIVER PITTENGER |
| K073707 |
12/31/2007 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K073582 |
12/20/2007 |
VRIICU SYSTEM |
DEEP BREEZE LTD. |
JEFF BAETZ |
| K070529 |
02/23/2007 |
AFF (MARK I) VOLUMETRIC INFUSION PUMP |
DEFINITIVE MEDICAL TECHNOLOGIES, LTD. |
BOAZ BARTOV |
| K073593 |
12/21/2007 |
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 |
| K073486 |
12/18/2007 |
DENTIS DENTAL IMPLANT SYSTEM |
DENTIS CO. LTD. |
CHANG DAE KYU |
| K070306 |
02/09/2007 |
PAINT- ON POLISH AGENT |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K070307 |
02/01/2007 |
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K070538 |
02/26/2007 |
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE |
DENTSPLY INTL. |
HELEN LEWIS |
| K073412 |
12/04/2007 |
GRYPHON BR AND HEALIX BR ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH FORSTADT |
| K070359 |
02/07/2007 |
DEPUY ASR TAPER SLEEVE ADAPTER |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K073529 |
12/26/2007 |
DEPUY SIGMA PS FEMORAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K073570 |
12/20/2007 |
DEPUY TRI-LOCK BONE PRESERVATION STEM |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K073649 |
12/26/2007 |
BENGAL STACKABLE CAGE SYSTEM |
DEPUY SPINE, INC. |
SHARON SLAROWICZ |
| K070387 |
02/09/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073562 |
12/19/2007 |
MODIFICATION TO VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073565 |
12/19/2007 |
STANDARD WHEELCHAIR PLATFORM |
DESIGN SPECIFIC LTD |
DAWN EDWARDS |
| K070351 |
02/06/2007 |
SPACE 360 DELIVERY SYSTEM |
DFINE, INC. |
ROBERT POSER |
| K070383 |
02/09/2007 |
ENZYMATIC CREATININE ASSAY (265 SERIES) |
DIAGNOSTIC CHEMICALS LTD. |
DEBBIE M MURRAY |
| K073390 |
12/03/2007 |
DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS |
DIASORIN, INC. |
MARI MEYER |
| K070542 |
02/26/2007 |
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS |
DIGIRAD CORP. |
JOEL TUCKEY |
| K073503 |
12/19/2007 |
VERSA LITE |
DIOMEDICS, INC. |
GARY MOCNIK |
| K073518 |
12/14/2007 |
FLASHLITE REBEL* |
DISCUS DENTAL, INC. |
VIVIAN LAI |
| K070536 |
02/27/2007 |
MEDILAS D FAMILY LASERS |
DORNIER MEDTECH AMERICA, INC. |
TIM THOMAS |
| K073427 |
12/07/2007 |
MEDILAS D FAMILY LASERS |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K070566 |
02/28/2007 |
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL |
DRAEGER MEDICAL SYSTEMS, INC. |
MARK KIERAS |
| K070407 |
02/12/2007 |
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE |
DUKAL CORP. |
PATRICK J LAMB |
| K073331 |
12/11/2007 |
DVO EXTENDED ARTICULATION HUMERAL HEADS |
DVO EXTREMITY SOLUTIONS, LLC |
JEFF ONDRLA |
| K070375 |
02/08/2007 |
EARLYSENSE ES-16 SYSTEM |
EARLYSENSE LTD. |
DORIT WINITZ |
| K073415 |
12/06/2007 |
NEMUS SYSTEM; NEMUS PC PERIPHERAL |
EB NEURO, S.P.A. |
ALLISON SCOTT |
| K073711 |
12/31/2007 |
MUCOGRAFT COLLAGEN MATRIX |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K073221 |
12/05/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K073559 |
12/19/2007 |
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
JOHN W NICHOLSON |
| K070320 |
02/02/2007 |
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 |
EDWARDS LIFESCIENCES SERVICES GMBH |
NEIL R ARMSTRONG |
| K070358 |
02/07/2007 |
MAXINSIGHT |
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
DANIEL KAMM |
| K073687 |
12/28/2007 |
HABIB LAPAROSCOPIC HEXABLATE |
EMCISION, LTD. |
NAGY HABIB |
| K070427 |
02/13/2007 |
DUPEL TRANSPORT IONTOPHORESIS SYSTEM |
EMPI |
SANDRA WALROD |
| K073510 |
12/26/2007 |
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K070367 |
02/15/2007 |
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K073644 |
12/26/2007 |
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES |
ENDOGASTRIC SOLUTIONS, INC. |
KEN PERINO |
| K073399 |
12/04/2007 |
TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE |
ENVISIONEERING, LLC. |
DAVID KENNEDY |
| K073709 |
12/31/2007 |
MODIFICATION TO VIEWMATE SYSTEM |
EP MEDSYSTEMS |
LARRY PICCIANO |
| K073507 |
12/14/2007 |
ANCHORAGE ACCESS KIT |
EPITEK, INC. |
WERNER HAMPL |
| K070494 |
02/20/2007 |
EPI-C PLUS |
ESPANSIONE MARKETING SPA |
GUIDO BONAPACE |
| K070401 |
02/12/2007 |
ENDO-CHX |
ESSENTIAL DENTAL SYSTEMS, INC. |
SUSAN GOLDSTEIN-FALK |
| K070084 |
02/06/2007 |
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL |
EST. ANTHOGYR |
ERIC GENEVE |
| K073484 |
12/11/2007 |
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 |
ETHICON ENDO-SURGERY, INC. |
RENEE L ROWE |
| K073688 |
12/28/2007 |
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW |
EXACTECH, INC. |
GRAHAM CUTHBERT |
| K070479 |
02/20/2007 |
EXACTECH NOVATION CROWN CUP AND LINERS |
EXACTECH, INC. |
MARITZA ELIAS |
| K073579 |
12/20/2007 |
DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN |
FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL |
NEIL R ARMSTRONG |
| K073706 |
12/31/2007 |
RESPIRATORY HUMIDIFIER, MODEL MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
ADELE BINDON |
| K073382 |
12/03/2007 |
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G |
FOCUS DIAGNOSTICS, INC. |
CONSTANCE BRIDGES |
| K073381 |
12/03/2007 |
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M |
FOCUS DIAGNOSTICS, INC. |
CONSTANCE BRIDGES |
| K073614 |
12/26/2007 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
DIANA HONG |
| K070355 |
02/06/2007 |
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY |
FOTONA D.D. |
STOJAN TROST |
| K073650 |
12/26/2007 |
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
DANIEL KAMM |
| K070393 |
02/09/2007 |
LAGWIRE SYSTEM |
FXDEVICES |
RICH LIPSCHUTZ |
| K070482 |
02/20/2007 |
ISIS |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K070414 |
02/12/2007 |
GAMBRO CARTRIDGE BLOOD SETS |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K073675 |
12/28/2007 |
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP |
GAYMAR INDUSTRIES, INC. |
BETHANY J GILBERT |
| K070319 |
02/05/2007 |
GC FUJI IX GP EXTRA |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
| K073588 |
12/26/2007 |
GC MODELS OPA-100 AND JC-50 |
GC AMERICA, INC. |
MARK HEISS |
| K070421 |
02/13/2007 |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 |
GE HEALTHCARE |
JOEL KENT |
| K073625 |
12/26/2007 |
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM |
GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES |
MARGARET MUCHA |
| K073462 |
12/10/2007 |
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOEL KENT |
| K073408 |
12/04/2007 |
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
NICOLE LANDREVILLE |
| K073543 |
12/17/2007 |
OEC 9900 ELITE |
GE OEC MEDICAL SYSTEMS |
MARIA C FRAME |
| K070475 |
02/20/2007 |
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K073439 |
12/07/2007 |
TRANSITION STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K073517 |
12/14/2007 |
H-LINK INTEGRATED ROD |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K073636 |
12/26/2007 |
TINNITUS SOUND GENERATOR MODULE |
GN RESOUND A/S |
LARS HAGANDER |
| K070419 |
02/16/2007 |
OPACIDEN OPA REAGENT STRIPS |
HACH COMPANY |
DAVID A MORRIS |
| K070513 |
02/22/2007 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K073576 |
12/19/2007 |
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES |
HAROD ENTERPRISES, INC. |
NORRIS R HAROD |
| K070543 |
02/27/2007 |
MODIFICATION TO HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH |
| K070489 |
02/20/2007 |
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K070493 |
02/20/2007 |
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K073554 |
12/18/2007 |
NEUN |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| K043617 |
12/21/2007 |
IMAGECHECKER CT CAD SOFTWARE SYSTEM |
HOLOGIC, INC. |
ARTHUR FRIEDMAN |
| K070398 |
02/12/2007 |
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 |
HOSPIRA, INC. |
NICOHL R WILDING |
| K070454 |
02/16/2007 |
OMEGA 3 SUPRACONDYLAR PLATE |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K073527 |
12/17/2007 |
VARIAX ELBOW SYSTEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K073656 |
12/26/2007 |
OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM |
HYPERMED, INC. |
CHAS BURR |
| K070532 |
02/26/2007 |
SPIROS |
ICU MEDICAL, INC |
MARTIN MAIER |
| K070468 |
02/21/2007 |
IMPLANT SCIENCES CORP. MODEL HDR 4454 |
IMPLANT SCIENCES CORP. |
MATTHEW HOLLOWS |
| K073664 |
12/26/2007 |
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER |
INJECTIMED, INC. |
RICHARD G HUNTER |
| K070312 |
02/01/2007 |
EARCHECK ACOUSTIC REFLECTOMETER |
INNOVIA MEDICAL, LLC |
KEVIN WALLS |
| K073545 |
12/19/2007 |
AUDICOR, HEMO AMBULATORY MONITOR |
INOVISE MEDICAL, INC. |
KENDRA RATHKEY |
| K073377 |
12/03/2007 |
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K073384 |
12/03/2007 |
SMART COUPLER, MODEL M015401 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K073690 |
12/28/2007 |
INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM |
INTERLACE MEDICAL, INC. |
RON ADAMS |
| K070354 |
02/06/2007 |
IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) |
INTERNATIONAL MEDICAL DEVELOPMENT, INC |
WALTER ZOHMANN |
| K073689 |
12/28/2007 |
LEP2000 THERAPY SYSTEM |
INTERNATIONAL MEDICAL INSTRUMENTS, INC. |
M. JOYCE HEINRICH |
| K073710 |
12/31/2007 |
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 |
INTOUCH TECHNOLOGIES |
BILL STOUT |
| K073404 |
12/04/2007 |
IFS LASER SYSTEM |
INTRALASE CORP. |
MAUREEN WEINER |
| K070321 |
02/05/2007 |
TWILIGHT FULL FACE MASK |
INVACARE CORP. |
CARROLL MARTIN |
| K070522 |
02/23/2007 |
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS |
KAREN MORTIMER |
| K070574 |
02/28/2007 |
FLEXITRON |
ISODOSE CONTROL B.V. |
HUB VAN DE BERGH |
| K070541 |
02/27/2007 |
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II |
IVIVI TECHNOLOGIES, INC. |
ANDRE DIMINO |
| K073704 |
12/31/2007 |
I-DIXEL |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K073696 |
12/31/2007 |
VERAVIEWEPOCS |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K073485 |
12/12/2007 |
VISTAKON (NARAFILCON) A SOFT CONTACT LENS |
JOHNSON & JOHNSON VISION CARE, INC. |
ROSALIND B WILLIAMS |
| K070491 |
02/20/2007 |
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 |
K-JUMP HEALTH CO., LTD. |
DANIEL WANG |
| K070353 |
02/06/2007 |
KELSEY INTERSITITAL LASER THERAPY SYSTEM |
KELSEY, INC. |
PAUL KETTERIDGE |
| K073519 |
12/14/2007 |
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 |
KENSEY NASH CORP. |
CINDY VARUGHESE |
| K070360 |
02/13/2007 |
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN P PRARIO |
| K070395 |
02/09/2007 |
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K070550 |
02/27/2007 |
AUSCO ES-3100 |
KORATEK COMPANY, LTD. |
PAUL SUMNER |
| K073590 |
12/20/2007 |
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K070325 |
02/07/2007 |
CLEARFIL MAJESTY ESTHETIC PLT |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K073516 |
12/14/2007 |
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR |
KYPHON, INC. |
PAMELA SEGALE |
| K070331 |
02/05/2007 |
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES |
LABORIE MEDICAL TECHNOLOGIES |
BARBARA MORNET |
| K073552 |
12/20/2007 |
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY |
LABORIE MEDICAL TECHNOLOGIES, CORP |
BARBARA MORNET |
| K073655 |
12/26/2007 |
PEGASUS STEERABLE (PTCA) GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K073702 |
12/31/2007 |
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR |
LAZARUS MEDICAL LLC |
CYNTHIA J.M NOLTE |
| K070341 |
02/06/2007 |
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM |
LDR SPINE USA |
JAMES BURROWS |
| K070523 |
02/23/2007 |
MODIFICATION TO: VELSCOPE |
LED DENTAL INC. |
DAVID C MORGAN, PHD |
| K070483 |
02/20/2007 |
LEONE MONOIMPLANT FOR O-RING OVERDENTURE |
LEONE SPA |
ELIA LADANI |
| K070433 |
02/14/2007 |
LERADO, POWER WHEELCHAIR, PB |
LERADO CHINA LIMITED |
JEN KE-MIN |
| K073479 |
12/11/2007 |
KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073480 |
12/11/2007 |
LIFE SPINE CROSS CONNECTOR |
LIFE SPINE |
REBECCA M BROOKS |
| K070560 |
02/27/2007 |
LRTM SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K073411 |
12/04/2007 |
LITEDUO |
LIGHT INSTRUMENTS |
YORAM LEVY |
| K070315 |
02/14/2007 |
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 |
LINA MEDICAL APS |
WALT BRITTLE |
| K063841 |
02/14/2007 |
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
LIPOSCIENCE |
MARK A DEL VECCHIO |
| K070400 |
02/12/2007 |
LC THERAPY, MODEL LCT-1000 |
LITECURE, LLC |
BRIAN PRYOR, PH.D. |
| K070344 |
02/06/2007 |
LIV BREAST SELF EXAMINATION AID |
LIV INTERNATIONAL USA, INC. |
PARTICK GORA |
| K073506 |
12/13/2007 |
LUMINEX LX 100/200 INSTRUMENT |
LUMINEX CORP. |
NANCY KRUNIC |
| DEN070013 |
12/04/2007 |
ID-TAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K070392 |
02/09/2007 |
MOSAIC LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K073436 |
12/06/2007 |
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K063427 |
02/20/2007 |
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM |
LYNTON LASERS LIMITED |
ANDREW JOHN BERRY |
| K073461 |
12/10/2007 |
ORTHO ANCHOR SCREWS |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K073592 |
12/20/2007 |
OPTISTAR ELITE INJECTION SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
DALE MOORE |
| K070442 |
02/15/2007 |
POWERLED SURGICAL LIGHT SYSTEM |
MAQUET S.A. |
KEVIN M TOMPKINS |
| K070557 |
02/27/2007 |
MP 719 |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K073468 |
12/27/2007 |
MIMICS |
MATERIALISE N.V. |
MIEKE JANSSEN |
| K073449 |
12/10/2007 |
SURGICASE |
MATERIALISE N.V. |
MIEKE JANSSEN |
| K073467 |
12/10/2007 |
SPINEASSIST SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K073497 |
12/13/2007 |
HDL CHOLESTEROL REAGENT, MODEL 10211 |
MEDICA CORP. |
PHOTIOS MAKRIS |
| K073476 |
12/10/2007 |
COMPACT AUTO-SAFETY INJECTOR (CASI) |
MEDICAL HOUSE (ASI) LIMITED |
ROSE Y GUANG |
| K070506 |
02/21/2007 |
SMS MULTI GLUCOSE CONTROL, MODEL 2120049 |
MEDICAL SPECIALTIES SUPPLY CO., INC. |
JOHN C GORMLEY |
| K073555 |
12/20/2007 |
INSULIN PROTECTOR |
MEDICOOL, INC. |
EUGENE CHANG |
| K070530 |
02/23/2007 |
MODIFICATION TO PASSMED SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K072942 |
12/06/2007 |
MEDLINE DISPOSABLE VAGINAL SPECULUM |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K073718 |
12/31/2007 |
MEDLINE GASTROSTOMY TUBE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K070577 |
02/28/2007 |
ON THE GO SHARPS |
MEDPORT, INC. |
FRAN WHITE |
| K073356 |
12/03/2007 |
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 |
MEDTRONIC MINIMED |
MARK J FAILLACE |
| K070438 |
02/15/2007 |
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 |
MEDTRONIC MINIMED, INC. |
JODIE ROGERS |
| K073139 |
12/12/2007 |
SMALL LUMEN PERITONEAL CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K070527 |
02/23/2007 |
ARCUATE VERTEBRAL AUGMENTATION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K070311 |
02/01/2007 |
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 |
MEDTRONIC VASCULAR |
DEBBIE KIDDER |
| K070356 |
02/06/2007 |
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K073456 |
12/10/2007 |
T-QUEST SYSTEM |
MEDX, INC. |
MICHAEL HANUSHEWSKY |
| K073556 |
12/19/2007 |
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS |
MEDXPERT GMBH |
FRANZ MENEAN |
| K073513 |
12/14/2007 |
MERITS E700 PORCE LIFT |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K070441 |
02/16/2007 |
METASURG SUBTALAR IMPLANT |
METASURG |
LARRY WEATHERFORD |
| K070488 |
02/20/2007 |
MICARDIA ANNULOPLASTY BAND DR |
MICARDIA CORPORATION |
JEFFREY P DUMONTELLE |
| K073397 |
12/03/2007 |
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K073398 |
12/03/2007 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K073401 |
12/04/2007 |
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 |
MICROMEDICS, INC. |
TOM LOPAC |
| K070456 |
02/16/2007 |
MICRUS COURIER ENZO MICROCATHETER 0.017 |
MICRUS ENDOVASCULAR CORPORATION |
R. MICHAEL CROMPTON |
| K073442 |
12/07/2007 |
MICRUS MICROCOIL SYSTEMS |
MICRUS ENDOVASCULAR CORPORATION |
JULIA GROSS |
| K070352 |
02/28/2007 |
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K070313 |
02/01/2007 |
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
| K070539 |
02/27/2007 |
MORTARA ELI 10 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
LAURA M SPIEGELHOFF |
| K073647 |
12/26/2007 |
MINITAPE EXTRA URETHRAL SLING |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K073646 |
12/26/2007 |
MINITAPE URETHRAL SLING |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K070347 |
02/06/2007 |
ALLOFIX PUSH-IN ANCHOR |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY L BENNEWITZ |
| K073521 |
12/17/2007 |
MUSMATE WALKING AID |
MUSMATE LTD |
ANDREW JAMES WYND |
| K073699 |
12/31/2007 |
MCT-DIABETES |
MYCARE TEAM, INC. |
DIANE MANDELL HORWITZ |
| K073652 |
12/26/2007 |
ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE |
NAKAMURA MAGNIFIER CO., LTD. |
CHARLIE ITO |
| K073665 |
12/26/2007 |
ALGO 5 NEWBORN HEARING SCREENER |
NATUS MEDICAL, INC. |
TOM BOLES |
| K073671 |
12/27/2007 |
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE |
NDO SURGICAL, INC. |
JOHN J VOZELLA |
| K073448 |
12/10/2007 |
MEDICAL DISPLAY, MD205MG |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
| K070408 |
02/12/2007 |
DURAMAX REUSABLE OXIMETRY SENSOR |
NELLCOR PURITAN BENNETT, INC. |
JAMES BONDS |
| K070416 |
02/12/2007 |
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP |
NEOFORCE GROUP, INC. |
MARY STANIEWICZ |
| K073596 |
12/21/2007 |
NEOMED SINGLE LUMEN UMBILICAL CATHETER |
NEOMED, INC. |
PENNY NORTHCUTT |
| K073651 |
12/26/2007 |
NEOTRACT ANCHOR SYSTEM |
NEOTRACT, INC. |
SUZAN MOSER |
| K073455 |
12/14/2007 |
E-VAC |
NEW LEAF MEDICAL, INC. |
RICHARD T NOCK |
| K070447 |
02/16/2007 |
NEWDEAL COMPRESSION PLATE |
NEWDEAL SAS |
JUDITH E O'GRADY |
| K073375 |
12/03/2007 |
NEWDEAL TIBIAXYS SYSTEM |
NEWDEAL SAS |
JUDITH O'GRADY |
| K070474 |
02/20/2007 |
NEWLIFE SCIENCES LLC, MODEL TMR |
NEWLIFE SCIENCES, LLC |
RONALD WEINSTOCK |
| K070500 |
02/21/2007 |
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM |
NI MEDICAL |
JAMES COLLIE |
| K073491 |
12/12/2007 |
EEG-1100A SWITCH BOX |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K073550 |
12/19/2007 |
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K070377 |
02/08/2007 |
GIRAFFE AND PANDA WARMER |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K073489 |
12/12/2007 |
OLYMPUS IGA REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K073490 |
12/12/2007 |
OLYMPUS IGG REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K073487 |
12/12/2007 |
OLYMPUS IGM REAGENT |
OLYMPUS AMERICA INC. |
STEPHANIE G DONNELLY |
| K070453 |
02/16/2007 |
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL |
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
STEPHANIE G SCHWARTZ |
| K073409 |
12/04/2007 |
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K073602 |
12/26/2007 |
MODIFICATION TO: APEX KNEE SYSTEM |
OMNLIFE SCIENCE |
WILLIAM MCCALLUM |
| K070575 |
02/28/2007 |
EVICEL APPLICATION DEVICE |
OMRIX BIOPHARMACEUTICALS LTD. |
DAVID NAKAR |
| K073407 |
12/04/2007 |
PACIFICA |
OR-NIM MEDICAL LTD. |
CAMPBELL HUTTON |
| K073670 |
12/27/2007 |
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 |
OREX COMPUTED RADIOGRAPHY LTD |
DAN LAOR |
| K070477 |
02/20/2007 |
ORISON EMBRACE SYSTEM |
ORISON CORPORATION |
JOHN DIXON |
| K073714 |
12/31/2007 |
TRAUMACAD VERSION 2.0 |
ORTHOCRAT, LTD. |
GEORGE J HATTUB |
| K073624 |
12/26/2007 |
MODULAR FOOT SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K070555 |
02/27/2007 |
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES |
ORTHOPRO LLC |
CHRISTOPHER COOK |
| K073720 |
12/31/2007 |
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT |
OSMETECH MOLECULAR DIAGNOSTICS |
ROBERT DICHECK |
| K073685 |
12/28/2007 |
OTA COLLAGEN BIOMATERIAL |
OSSEOUS TECHNOLOGIES OF AMERICA |
DAVID J COLLETTE |
| K073465 |
12/14/2007 |
US/GS ULTRA WIDE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K073405 |
12/04/2007 |
PLEXUR M |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K073617 |
12/28/2007 |
PHARAON LIPO |
OSYRIS |
JAOUAD ZEMMOURI |
| K073512 |
12/18/2007 |
START JUNIOR |
OTTO BOCK HEALTH CARE, LP |
BERT HERMAN |
| K070318 |
02/02/2007 |
SKIPPI POWERED WHEELCHAIR FOR CHILDREN |
OTTO BOCK HEALTHCARE, LP |
SHANNON TUFVANDER |
| K070505 |
02/21/2007 |
KRYSTAL-X WIFI |
OWANDY |
CLAUDE BERTHOIN |
| K070350 |
02/06/2007 |
P&F POWER WHEELCHAIR, HC-510 |
P&F BROTHER IND.,CORP |
KE-MIN JEN |
| K073568 |
12/20/2007 |
PSL BIOZIR BLOCK |
P.S.L. INTERNATIONAL INC. |
CATHERINE FENG |
| K073386 |
12/03/2007 |
JOINT STIM, MODEL 1000 |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K073363 |
12/11/2007 |
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 |
PALADIN BIOMEDICAL CORPORATION |
ROBERT BICKFORD |
| K073583 |
12/20/2007 |
MODIFICATION TO PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE |
| K070498 |
02/20/2007 |
HYPER SAL |
PARI INNOVATIVE MANUFACTURERS, INC. |
PAUL DRYDEN |
| K073698 |
12/31/2007 |
SECURE |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K070545 |
02/26/2007 |
K-Y BRAND WARMING LIQUID |
PERSONAL PRODUCTS CO. |
NADER FOTOUHI |
| K073376 |
12/03/2007 |
PHILIPS ECG ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K070528 |
02/23/2007 |
PHILIPS ESSENTA DR |
PHILIPS MEDICAL SYSTEMS GMBH, DMC |
LYNN HARMER |
| K073477 |
12/17/2007 |
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS |
PHOTONOVA OFSWEDEN AB |
CONNIE HOY |
| K070551 |
02/27/2007 |
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K070335 |
02/05/2007 |
SIMPLEX CERVICAL FIXATION SYSTEM |
PISHARODI SURGICALS, INC. |
J.D. WEBB |
| K073662 |
12/26/2007 |
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS |
PLAYTEX PRODUCTS, INC. |
KEITH EDGETT |
| K070504 |
02/27/2007 |
AMMONIA/ALCOHOL CONTROL SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K070467 |
02/16/2007 |
HEALTH MASK |
POLAR WRAP LLC |
PAUL DRYDEN |
| K070559 |
02/27/2007 |
POLYMAP PWR-08-03 |
POLYMAP WIRELESS |
PIERRE LANDAU |
| K073441 |
12/07/2007 |
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K070363 |
02/07/2007 |
FETCH ASPIRATION CATHETER |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
| K073708 |
12/31/2007 |
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN |
| K073693 |
12/31/2007 |
COSTORSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K073542 |
12/18/2007 |
CYCLETRAC CT-5000 |
PT PRODUCTS, LLC |
MICHELE CONWAY |
| K073630 |
12/26/2007 |
MODIFICATION TO: BPCARD, MODEL Z-7000-0700 |
QRS DIAGNOSTIC, LLC. |
MARY KAY JENSEN |
| K073549 |
12/18/2007 |
Q-PLUS T |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K070484 |
02/20/2007 |
QUANTRX FEMALE FERTILITY TEST |
QUANTRX BIOMEDICAL CORPORATION |
LORRAINE C COGAN |
| K070309 |
02/07/2007 |
NEOSALUS |
QUINNOVA PHARMACEUTICALS |
JEFFREY DAY |
| K070334 |
02/26/2007 |
R&D SICKLE QC CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K070305 |
02/05/2007 |
PRE-LOADED VISICOIL |
RADIOMED CORPORATION |
GORDON ROBERTS |
| K070502 |
02/23/2007 |
RADIUS SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
RICHARD DEMELLO |
| K070338 |
02/06/2007 |
RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS |
RAINBOW COMMUNICATIONS, INC |
LEON E JEW |
| K070412 |
02/28/2007 |
ELEXOMA MEDIC |
REDPLANE AG |
JAEN LABUSCHAGNE |
| K070534 |
02/28/2007 |
MODIFICATION TO: OCU-FILM TIP COVER |
REICHERT, INC. |
SANDRA BROWN |
| K073349 |
12/31/2007 |
RELIANCE BUTTRESS WASHER SYSTEM |
RELIANCE MEDICAL SYSTEMS, LLC |
BRET M BERRY |
| K070443 |
02/20/2007 |
INTRACEPT BI-POLAR RF PROBE, MODEL 04814 |
RELIEVANT MEDSYSTEMS, INC. |
MARK SMUTKA |
| K073638 |
12/26/2007 |
SWIFT LT |
RESMED LTD. |
DAVID D'CRUZ |
| K070328 |
02/05/2007 |
BIPAP SYNCHRONY WITH AVAPS |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K073600 |
12/21/2007 |
COMFORTGEL FULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA T YURKOS |
| K070463 |
02/16/2007 |
REVERA WOUND CARE, MODEL MDW0060 |
REVALESIO CORPORATION |
GREG J ARCHAMBEAU |
| K070511 |
02/26/2007 |
RICHTER MALE LATEX CONDOM |
RICHTER RUBBER TECHNOLOGY SBN BHD |
SUBRAMANIAM NARAYANASAMY |
| K073419 |
12/05/2007 |
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES |
RJ MEDICAL, INC. |
JIM INNES |
| K073544 |
12/18/2007 |
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES |
RJ MEDICAL, INC. |
JIM INNES |
| K070391 |
02/09/2007 |
ELECSYS PTH TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY TAYLOR |
| K073501 |
12/13/2007 |
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG |
ROCHE DIAGNOSTICS CORP. |
THERESA A BUSH |
| K070200 |
02/02/2007 |
TDM CONTROL SET, MODEL CAT# 04521536 |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K070316 |
02/01/2007 |
INTERPLATE VBR SYSTEM |
RSB SPINE LLC. |
KAREN E WARDEN |
| K073498 |
12/19/2007 |
LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM |
RUDOLF MEDICAL GMBH + CO. KG |
FRANZ MENEAN |
| K073522 |
12/14/2007 |
VITRIFICATION KIT & VITRIFICATION WARMING KIT |
SAGE IN-VITRO FERTILIZATION INC. |
GRACE HOLLAND |
| K073500 |
12/13/2007 |
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM |
SANACOR |
MIKE ENSIGN |
| K073533 |
12/17/2007 |
SANARUS V2 TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
LISA HENRY |
| K070507 |
02/27/2007 |
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW |
SCIENCE FOR BIOMATERIALS |
DENIS CLEMENT |
| K070388 |
02/13/2007 |
PROFILE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K070486 |
02/20/2007 |
CAPILLARYS URINE (PN 2012) |
SEBIA, INC. |
KAREN ANDERSON |
| K070397 |
02/12/2007 |
DGSCOPE, RELEASE 1.0 |
SEGAMI CORPORATION |
PHILIPPE BRIANDET |
| K073634 |
12/26/2007 |
MULTIGENT CREATININE (ENZYMATIC) ASSAY |
SENTINEL CH. SPA |
FABIO ROTA |
| K073705 |
12/31/2007 |
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE |
SHANDONG QIAOPAI GROUP CO., LTD |
MARK JOB |
| K070501 |
02/21/2007 |
RUIKE 3421 POWERED WHEELCHAIR |
SHANGHAI RUIKE SPORTS GOODS CO., LTD. |
JUNNATA CHANG |
| K073577 |
12/20/2007 |
SHARPS TRANSPORT TUBE, MODEL 50035 |
SHARPS COMPLIANCE, INC. |
DAVID OLMSTEAD |
| K073684 |
12/28/2007 |
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL |
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. |
KATHLEEN HACKU |
| K070526 |
02/23/2007 |
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K073418 |
12/05/2007 |
SYNGO IMAGING CCF VA10A |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K073373 |
12/03/2007 |
SYNGO VOLUME PERFUSION-CT BODY |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K073537 |
12/17/2007 |
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
NOOR MALKI |
| K070576 |
02/28/2007 |
ACUSON X150 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
| K070322 |
02/02/2007 |
SYNGO DYNAMICS, VERSION 6.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SIEGLINDE NINA WEST |
| K073674 |
12/28/2007 |
BONE FIXATION WIRE (KIRSCHNER WIRE) |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K073635 |
12/26/2007 |
SBI SR MTP TOE IMPLANT |
SMALL BONE INNOVATIONS INC. |
JEFFREY ZIGLER |
| K073551 |
12/18/2007 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JULIE ACKER |
| K070565 |
02/28/2007 |
COFIELD TOTAL SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
MARLON D RIDLEY |
| K073466 |
12/10/2007 |
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM |
SMITH & NEPHEW, INC. |
MASON W ROBBINS |
| K073509 |
12/13/2007 |
TWINFIX PK FP SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K070340 |
02/09/2007 |
SECURE ARTERIAL BLOOD SAMPLING SYSTEM |
SMITHS MEDICAL ASD, INC. |
BARBARA LAW |
| K073380 |
12/03/2007 |
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K070449 |
02/26/2007 |
LUMILOC (TM) SAFETY INTRODUCER NEEDLE |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
MARK NELSON |
| K070417 |
02/12/2007 |
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 |
ST. JUDE MEDICAL |
LAURA MOEN-FTACEK |
| K073563 |
12/19/2007 |
MODIFICATION TO PROXIS SYSTEM |
ST. JUDE MEDICAL |
LINH PHAM |
| K073700 |
12/31/2007 |
6F PROXIS SYSTEM |
ST. JUDE MEDICAL, INC. |
LINH PHAM |
| K073586 |
12/26/2007 |
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM |
STAAR SURGICAL CO. |
DIANA SMITH |
| K073591 |
12/26/2007 |
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM |
STAAR SURGICAL CO. |
DIANA SMITH |
| K073613 |
12/21/2007 |
REPROCESSED SCISSOR TIPS |
STERILMED, INC. |
JOSHUA CLARIN |
| K073683 |
12/28/2007 |
VERIFY CHALLENGE PACKS - VERSION 2 |
STERIS CORPORATION |
JOHN SCOVILLE |
| K073618 |
12/26/2007 |
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK |
STERIS CORPORATION |
JOHN R SCOVILLE |
| K070461 |
02/16/2007 |
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 |
STERIS CORPORATION |
JOHN SCOVILLE |
| K070336 |
02/15/2007 |
STOCKERT NEURO N50, MODEL12267 |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K070478 |
02/20/2007 |
P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) |
STRAUMANN MANUFACTURING, INC. |
ELAINE ALAN |
| K073628 |
12/26/2007 |
SYNOCTA ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K070368 |
02/08/2007 |
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM |
STRYKER CORP. |
SIMONA VOIC |
| K073633 |
12/26/2007 |
STRYKER ESSX MICRODEBRIDER SYSTEM |
STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
COLETTE O'CONNOR |
| K073470 |
12/10/2007 |
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX |
STRYKER SPINE |
SIMONA VOIC |
| K073437 |
12/06/2007 |
THOR ANTERIOR PLATING SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K070457 |
02/20/2007 |
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB |
SUN SCIENTIFIC LLC |
JOSEPH AZARY |
| K063680 |
02/07/2007 |
SHARPOINT PDO (POLYDIOXANONE) SUTURES |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K073450 |
12/10/2007 |
SUTTER ELECTROSURGICAL CABLES |
SUTTER MEDIZINTECHNIK GMBH |
THOMAS A BOONE |
| K070327 |
02/05/2007 |
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K073478 |
12/11/2007 |
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K073715 |
12/31/2007 |
ELIPO |
SYNERON MEDICAL LTD. |
YONI IGER |
| K073572 |
12/19/2007 |
MATRIX RF APPLICATOR |
SYNERON MEDICAL LTD. |
YONI IGER |
| K073460 |
12/10/2007 |
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K073402 |
12/04/2007 |
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K073372 |
12/03/2007 |
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) |
SYSTEMSONE |
THOMAS ARTHUR |
| K073622 |
12/26/2007 |
EASY GRIP DENTAL IMPLANT SYSTEM |
T.F.I. SYSTEM S.R.L |
DOTT. CLAUDIO MECHELLI |
| K073667 |
12/26/2007 |
NITI-S BILIARY STENT |
TAEWOONG MEDICAL CO., LTD |
CATHRYN N CAMBRIA |
| K073494 |
12/19/2007 |
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING |
TAIDOC TECHNOLOGY CORPORATION |
YUHUA CHEN |
| K070472 |
02/20/2007 |
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 |
TAIDOC TECHNOLOGY CORPORATION |
ERICA LI |
| K073445 |
12/07/2007 |
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 |
TAIDOC TECHNOLOGY CORPORATION |
ERICA LI |
| K070404 |
02/12/2007 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K073532 |
12/17/2007 |
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES |
TECHNOMED EUROPE |
MAURICE ROOST |
| K073370 |
12/13/2007 |
TC MATRIX CLINICAL CHEMISTRY ANALYZER |
TECO DIAGNOSTICS |
JIM VAECHHES |
| K070561 |
02/27/2007 |
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES |
TELEFLEX MEDICAL |
LORI HAYS |
| K073474 |
12/11/2007 |
CAPIOX CIRCUIT CONNECTORS |
TERUMO CORP. |
GARRY COURTNEY |
| K070362 |
02/07/2007 |
SURFLO WINGED INFUSION SET |
TERUMO EUROPE N.V. |
M J AERTS |
| K070547 |
02/26/2007 |
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K070423 |
02/13/2007 |
TR BAND |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K073581 |
12/20/2007 |
ICI P AND S SERIES IR CAMERAS |
TEXAS INFRARED |
IAN P GORDON |
| K070381 |
02/09/2007 |
THEKEN VU MESH VBR SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K070531 |
02/23/2007 |
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER |
THERMO FISHER SCIENTIFIC |
BOLA NICHOLSON |
| K073612 |
12/21/2007 |
URIC ACID (AOX), SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K070385 |
02/09/2007 |
TI-TAMED SPINAL SYSTEM |
TI-TAMED (PTY) LTD |
SANDRA MORTIMER |
| K073431 |
12/14/2007 |
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T |
TIANJIN NEW BAY BIORESEARCH CO., LTD. |
ARMANDO TORRESCANO |
| K073495 |
12/12/2007 |
TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT |
TISSUELINK MEDICAL, INC. |
SOM KOVVURI |
| K070370 |
02/08/2007 |
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K073514 |
12/14/2007 |
TRANS1 AXIAL FIXATON SYSTEM |
TRANS1 INCORPORATED |
WILLIAM JACKSON |
| K073643 |
12/26/2007 |
TRANS1 AXIALIF 2-LEVEL OR II SYSTEM |
TRANS1 INCORPORATED |
ROBERT SHERIDAN |
| K073515 |
12/14/2007 |
TRANS1 FACET SCREW |
TRANS1 INCORPORATED |
WILLIAM JACKSON |
| K073432 |
12/06/2007 |
TRAUSON BONE PLATE |
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
DIANA HONG |
| K073653 |
12/26/2007 |
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K073424 |
12/05/2007 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K073558 |
12/19/2007 |
SENSITITRE 18-24 SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K073444 |
12/11/2007 |
TRITON MEIDCAL TMED IV-SET |
TRITON MEDICAL, LLC |
IAN P GORDON |
| K073435 |
12/06/2007 |
KODAK 9000, KODAK 9000 3D |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K073492 |
12/12/2007 |
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K070420 |
02/20/2007 |
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 |
UNITED STATES ENDOSCOPY GROUP, INC. |
MICHAEL WOLF |
| K070430 |
02/14/2007 |
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS |
UNOMEDICAL A/S |
JOHN M LINDSKOG |
| K070446 |
02/15/2007 |
COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL |
VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP |
JULIE ROSS |
| K070372 |
02/08/2007 |
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| K073585 |
12/20/2007 |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 |
VASCULAR SOLUTIONS, INC. |
ALYSSA MALINSKI |
| K070403 |
02/12/2007 |
PRONTO .035" EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
DORALIE POGANSKI |
| K070323 |
02/02/2007 |
TEMPORARY LIMB SALVAGE SHUNT |
VASCUTEK LTD. |
KAREN KELSO |
| K073400 |
12/04/2007 |
VARICATH PERIPHERAL INFUSION CATHETER |
VEINRX INC. |
GREGORY MATHISON |
| K073694 |
12/31/2007 |
IVENT 2001 MRI CONDITIONAL |
VERSAMED MEDICAL SYSTEMS, INC. |
PAUL DRYDEN |
| K073502 |
12/13/2007 |
VERTEBRON VBR SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K070563 |
02/27/2007 |
VIDAR VISION 2000 |
VIDAR SYSTEMS CORP. |
JAMES M TAYLOR |
| K070535 |
02/26/2007 |
RETROPAN CCD-TWAIN-USB |
VIDEO DENTAL CONCEPTS, INC. |
CLAUDE BERTHOIN |
| K070390 |
02/09/2007 |
FLUOROPRO RF DIGITAL IMAGING SYSTEM |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K073473 |
12/14/2007 |
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 |
VOLCANO CORPORATION |
ARLENE BLADES |
| K070487 |
02/20/2007 |
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX |
VOLCANO CORPORATION |
CYNTHIA VAN DUKER |
| K070406 |
02/12/2007 |
ENDODRAPE |
VORTEK SURGICAL, LLC |
THOMAS SZYMCZAK |
| K073673 |
12/27/2007 |
SOYALA FULL FACE MASK GEL VENTED |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K073383 |
12/04/2007 |
WELL LEAD REINFORCED ENDOTRACHEAL TUBE |
WELL LEAD MEDICAL INSTRUMENTS |
ARTHUR J WARD |
| K070435 |
02/15/2007 |
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 |
WHITTLESTONE, INC. |
GLEN THIBAULT |
| K070326 |
02/05/2007 |
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM |
WIDEMED LTD |
DORIT WINITZ |
| K073374 |
12/03/2007 |
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET |
WILLIAM COOK EUROPE APS |
MOLLY BUSENBARK |
| K073535 |
12/17/2007 |
BIOFOAM BONE WEDGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRAD SHEALS |
| K070525 |
02/28/2007 |
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K070437 |
02/15/2007 |
PRO-DENSE BONE VOID FILLER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K070308 |
02/01/2007 |
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR |
X-CEL CONTACTS |
KEVIN RANDALL |
| K073482 |
12/14/2007 |
ALLOMAP MOLECULAR EXPRESSION TESTING |
XDX |
ROSE ROMEO |
| K073457 |
12/10/2007 |
MSTAR MPD4500 |
XINAOMDT TECHNOLOGY CO., LTD. |
DIANE HONG |
| K070473 |
02/21/2007 |
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
CHENG ROEI-SHENG |
| K073620 |
12/26/2007 |
GUARDIAN HEMOSTASIS VALVE |
ZERUSA LIMITED |
GER BRETT |
| K070317 |
02/06/2007 |
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K070519 |
02/22/2007 |
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES |
ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD. |
Y. T YEO |
| K073567 |
12/20/2007 |
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES |
ZIMMER GMBH |
PATRICIA JENKS |
| K070382 |
02/08/2007 |
VISTA -S DEVICE |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JENNIFER P HARAKAL |
| K073499 |
12/13/2007 |
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES |
ZIMMER, INC. |
ERIC S PITTMAN |
| K070455 |
02/20/2007 |
ZOLL E SERIES WITH SEE-THRU CPR |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
