FDA 510(k) Applications Received During November, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K063458 11/15/2006 3M TEGADERM CHG DRESSING 3M COMPANY MARIA RUIZ
K063526 11/22/2006 A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER A-M SYSTEMS, INC. JAY MANSOUR
K063329 11/03/2006 ABBOTT ARCHITECT HAVAB-M ABBOTT LABORATORIES JOSEPH C ORLOWSKI
K063481 11/17/2006 MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM ABBOTT VASCULAR INC. NADINE SMITH
K063449 11/15/2006 DELUXE NEBULIZER ACCESS POINT MEDICAL, L.L.C. JAMES W SANDBERG
K063418 11/13/2006 ACON DIGITAL THERMOMETER PROBE COVERS ACON LABORATORIES, INC. JINN-NAN LIN, PH.D
K063295 11/01/2006 ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON LABORATORIES, INC. JINN-NAN LIN
K063460 11/15/2006 ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K063409 11/13/2006 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX CONNIE HERTEL
K063421 11/13/2006 DX-SI AGFA CORP. JEFFERY A JEDLICKA
K063583 11/30/2006 ALCON VISION SYSTEM ALCON TERRY J DAGNON
K063545 11/24/2006 MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE ALFA SCIENTIFIC DESIGNS, INC. DAITING RONG
K063306 11/01/2006 ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 ALFA WASSERMANN, INC. MURRAY ROSENTHAL, PHD
K063364 11/07/2006 ALPHA BIO DENTAL IMPLANT SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K063511 11/20/2006 CERAMILL ZI AMANN GIRRBACH AMERICA, INC. DANIEL KAMM
K063379 11/08/2006 AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 AMEDICA BIOTECH, INC. Jeff Chen
K063323 11/03/2006 SPECTROLYSE PAI-1, MODEL 101201 AMERICAN DIAGNOSTICA, INC. DAVID TEICHER
K063519 11/21/2006 DYNAMIC GAS SCAVENGING SYSTEM (DGSS) ANESTHETIC GAS RECLAMATION LLC JAMES M BERRY
K063461 11/15/2006 ANOVA CONTAINMENT DEVICE ANOVA CORPORATION CAMPBELL TUSKEY
K063424 11/13/2006 FILM DIGITZER, MODEL 2908 MAMMO PRO ARRAY CORP. TAKASHI INAMI
K063479 11/17/2006 ARTHREX PUSHLOCK ARTHREX, INC. ANN WATERHOUSE
K063538 11/24/2006 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K063370 11/08/2006 CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY ARTHROSURFACE, INC. DAWN J WILSON
K063464 11/16/2006 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE INC. JEANNETTE G DAILEY
K063347 11/06/2006 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 AXIS-SHIELD DIAGNOSTICS, LTD. ERICA CONWAY
K063470 11/16/2006 AYCAN WORKSTATION OSIRIX AYCAN DIGITALSYSTEME GMBH CARL ALLETTO
K063532 11/22/2006 BARD E LUMINEXX BILIARY STENT BARD PERIPHERAL VASCULAR, INC. LINDSAY K PACK
K063331 11/03/2006 BAUSCH & LOMB NGX MICROSURGICAL SYSTEM BAUSCH & LOMB, INC. LISA C GRANEY
K063573 11/29/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML BECTON DICKINSON & CO. VICKI KENNEDY WHITLEY
K063301 11/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063300 11/01/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K063486 11/17/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY BECTON, DICKINSON & CO. MONICA E GIGUERE
K063318 11/02/2006 MONOLISA ANTI-HAV EIA Bio-Rad Laboratories MANUELA KAUL
K063319 11/02/2006 MONOLISA ANTI-HAV IGM EIA Bio-Rad Laboratories MANUELA KAUL
K063400 11/09/2006 VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K063495 11/20/2006 C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS BIOMATERIALS KOREA INC. KEVIN WALLS, RAC
K063527 11/22/2006 MBCP+ BIOMATLANTE ADELINE FILLIATRE
K063492 11/17/2006 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOHN TENLLADO
K063570 11/29/2006 BIOMET TIBIAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K063515 11/21/2006 TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE BIOMET MANUFACTURING, INC. SUSAN ALEXANDER
K063393 11/09/2006 SMALL STATURE SPACERS BIOMET SPINE SUSAN ALEXANDER
K063398 11/09/2006 ESA LEADCARE II LEAD CONTROL BIONOSTICS, INC. RANDY BYRD
K063343 11/06/2006 BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM BIOPTIGEN, INC. RUSSELL PAGANO
K063505 11/20/2006 VISUALASE ENVISION SOFTWARE SYSTEM BIOTEX, INC. MATHEW FOX
K063313 11/02/2006 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) BOSTON SCIENTIFIC CORP. DONNA PAGE
K063493 11/20/2006 I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 BOSTON SCIENTIFIC CORP. CHRISTINE DUNBAR
K063312 11/02/2006 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K063476 11/16/2006 BREAS ISLEEP 20I BREAS MEDICAL AB KARL-JOHAN HOLM
K063446 11/15/2006 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. PEGGY KEIFFER
K063377 11/08/2006 POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER C.R. BARD, INC. MICHAELA RIVKOWICH
K063308 11/02/2006 ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 CARBYLAN BIOSURGERY ROXANNE DUBOIS
K063288 11/01/2006 SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X CARDINAL HEALTH 303, INC. STACY L LEWIS
K063378 11/08/2006 CIRRUS HD-OCT, MODEL 4000 CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K063579 11/30/2006 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063289 11/01/2006 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063291 11/01/2006 INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K063353 11/06/2006 CTBOX CERVICAL/LUMBAR TRACTION CIRCULAR TRACTION SUPPLY, INC. DONALD W MEYER
K063432 11/13/2006 CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) CONFORMIS, INC. MICHAEL SHARP
K063326 11/03/2006 CONMED LINVATEC 24K IRRIGATION SYSTEM CONMED LINVATEC SUE F DAUTERMAN
K063457 11/15/2006 TRUEHD (1080P) DIGITAL CAMERA SYSTEM CONMED LINVATEC ELIZABETH PAUL
K063588 11/30/2006 MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 CONMED LINVATEC BIOMATERIALS PAIVI MESIRANTA
K063563 11/28/2006 CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER CORDIS EUROPA, N.V. JOAN MARTIN
K063349 11/06/2006 CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR CORMATRIX CARDIOVASCULAR, INC. KIT CARIQUITAN
K063351 11/06/2006 DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K063425 11/13/2006 DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063508 11/20/2006 DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN DADE BEHRING, INC. HELEN M LEE
K063322 11/03/2006 DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063299 11/01/2006 MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN DADE BEHRING, INC. MAY MORISHIMA
K063366 11/07/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE DADE BEHRING, INC. ROBERT EUSEBIO
K063564 11/28/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K063356 11/07/2006 STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK DADE BEHRING, INC. PAMELA A JURGA
K063365 11/07/2006 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE DADE BEHRING, INC. ROBERT EUSEBIO
K063466 11/16/2006 TOP FINE DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. DANIEL KAMM
K063348 11/06/2006 TOP FINE INSULIN SYRINGE DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. DANIEL KAMM
K063525 11/22/2006 DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM DATASCOPE CORP. NANCY COHEN
K063442 11/14/2006 ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR DEGANIA SILICONE, LTD. ZOYA LEE
K063483 11/17/2006 DEN TEK NIGHTGUARD DENTEK ORAL CARE, INC. Jeffrey Shapiro
K063478 11/17/2006 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
K063509 11/20/2006 DEPUY PEAK FX HIP PLATE DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K063482 11/17/2006 CROSSPLAN / ACCUSOFT-XL V.4.04 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K063444 11/15/2006 TOTAL ETCH BONDING AGENT DMG USA, INC. PAMELA PAPINEAU
K063443 11/14/2006 DRAEGER ALCOTEST 6510 DRAGER SAFETY EVE DAMIANO
K063469 11/16/2006 MEDICAN ALPHA EASTERN MEDIKIT LTD. RAJEEV ASRI
K063346 11/03/2006 PRO OSTEON 500R EBI, L.P. DEBRA BING
K063293 11/01/2006 EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K063512 11/20/2006 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K063453 11/15/2006 VERTEFIX PEDICLE SCREW SPINAL SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD. CHARISE DE BARRIOS
K063448 11/15/2006 EMG AC/DC SUCTION UNIT EMG TECHNOLOGY CO., LTD. SALLY CHUANG
K063406 11/09/2006 ENCORE KNEE SYSTEM IFU ENCORE MEDICAL, L.P. TEFFANY HUTTO
K063414 11/13/2006 MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K063562 11/27/2006 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC. PATRICE NAGODA
K063569 11/29/2006 EQUINOXE REVERSE SHOULDER SYSTEM EXACTECH, INC. AMNON TALMOR
K063447 11/15/2006 INSIGHT DISCOVERY FASSTECH LEE BRODY
K063363 11/07/2006 FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE FLEXICATH LTD. AHAVA STEIN
K063316 11/02/2006 FUJINON MODEL EG-530N TRANS NASAL INSERTION FUJINON, INC. JOSEPH AZARY
K063290 11/01/2006 GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K063324 11/03/2006 PET VCAR GE HEALTHCARE LARRY A KROGER
K063451 11/15/2006 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 GEN-PROBE, INC. E. JOSEPH MCMULLEN
K063429 11/13/2006 GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 GENERIC MEDICAL DEVICE, INC. MONICA MONTANEZ
K063374 11/08/2006 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE Grace Medical, Inc. JEFF COBB
K063357 11/07/2006 MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES GREINER BIO-ONE NORTH AMERICA, INC. Judi Smith
K063380 11/08/2006 ECHOSTIM FACET TIP HAVEL'S, INC. PATRICK CARROTHERS
K063517 11/21/2006 HEALADEX-P HEALAGENICS, INC. PAUL STRATI
K063513 11/21/2006 ECHELON MR-RCC-150 CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS J THISTLEWAITE
K063518 11/21/2006 HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K063524 11/22/2006 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) HL RUBBER INDUSTRIES SDN BHD KENNY HOE
K063522 11/22/2006 POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) HL RUBBER INDUSTRIES SDN BHD KENNY HOE
K063423 11/13/2006 TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT HOWMEDICA OSTEONICS SHERYL R BAGALIO
K063445 11/15/2006 PCA CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063552 11/24/2006 SERIES II CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063550 11/24/2006 SYSTEM 12 CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063384 11/08/2006 DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 HOYA CONBIO, INC LIZA BURNS
K063530 11/22/2006 ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP I-FLOW CORP. JAMES J DAL PORTO
K063320 11/02/2006 ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) IMC-HEARTWAY, LLC MICHAEL CHEN
K063474 11/16/2006 ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) IMC-HEARTWAY, LLC MICHAEL CHEN
K063307 11/01/2006 ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) IMC-HEARTWAY, LLC MICHAEL CHEN
K063328 11/03/2006 IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) IMC-HEARTWAY, LLC MICHAEL CHEN
K063475 11/16/2006 IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) IMC-HEARTWAY, LLC MICHAEL CHEN
K063392 11/09/2006 IMCO-STAT IMCO TECHNOLOGIES MARK L SCHWARTZ
K063341 11/06/2006 3I OSSEOTITE CERTAIN DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K063403 11/09/2006 CONICAL ANGLED ABUTMENT IMPLANT INNOVATIONS, INC. TAMARA NELSON
K063390 11/09/2006 URINE CHEMISTRY ANALYZER UR-50 IND DIAGNOSTIC INC. BRIAN LEMAY
K063410 11/13/2006 INION CPS/OTPS FREEDOMPLATE INION LTD. KATI MARTTINEN
K063422 11/13/2006 BIOAGGREGATE INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K063565 11/28/2006 QUANTA LITE SS-A 52 ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K063402 11/09/2006 WICK ELECTRODE, MODEL M019260 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K063484 11/17/2006 PATIENT DATA HANDLER & DEVICES (PDH&D) INTERMED ADVISORS, INC. CHRISTINA VULLO
K063465 11/16/2006 CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE IOMED, INC. CURTIS JENSON
K063359 11/07/2006 INQU ISTO TECHNOLOGIES, INC. GARY GAGE
K063529 11/22/2006 PENCURE, MODEL VL-7 J. MORITA USA, INC. ROBERT A SILVERMAN
K063577 11/30/2006 FEMORAL INTRAFIX SCREW AND SHEATH JOHNSON & JOHNSON COMPANY Ruth Forstadt
K063399 11/09/2006 ALEUTIAN SPACER SYSTEM K2M, INC. RICH WOODS
K063544 11/24/2006 MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM K2M, INC. RICH WOODS
K063426 11/13/2006 V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10 KCI USA, INC. VERONIQUE SMITH
K063396 11/09/2006 VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES LASERING S.R.L. ALLEN R HOWES
K063546 11/24/2006 INSUFLOW DEVICE, MODEL 6198 LEXION MEDICAL, LLC. DUANE LLOYD
K063297 11/01/2006 LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR LIGHTMED CORP. DENNIS DOWELL
K063354 11/06/2006 LINDE INTEGRATED VALVE (LIV) LINDE GAS THERAPEUTICS JAMES J ROGERS
K063427 11/13/2006 LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM LYNTON LASERS LIMITED ANDREW JOHN BERRY
K063452 11/15/2006 MA 55 MAESTRO MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) DANIEL EGGAN
K063501 11/20/2006 KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K063503 11/20/2006 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS DALE MOORE
K063404 11/09/2006 SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 MAQUET CRITICAL CARE AB JAMIE YIEH
K063333 11/06/2006 M3 MAVIG GMBH CHRISTIAN STOIAN
K063488 11/17/2006 MAXO2 CU MAXTEC, INC. PAUL DRYDEN
K063472 11/15/2006 ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 MEDA LTD. EDWARD A KROLL
K063433 11/13/2006 ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 MEDA LTD. EDWARD A KROLL
K063336 11/06/2006 MEDELA DOMINANT 50 LIPO, MODEL 600-5706 MEDELA AG WERNER FREI
K063376 11/08/2006 EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER MEDICA CORP. Photios Makris
K063574 11/29/2006 LUMINEX LL LASER SYSTEM MEDICAL LASER SYSTEMS INC MIKI KOLTON
K063339 11/06/2006 MEDICK MHM200 PERSONAL HEART MONITOR MEDICK HEALTHCARE LTD. JAMES W SANDBERG
K063580 11/30/2006 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K063504 11/20/2006 ECONOLITH EM1000 MEDISPEC, LTD. ANIL DHINGRA
K063468 11/16/2006 THE FUGO BLADE FOR DENTISTRY MEDISURG LTD. RICHARD J FUGO
K063342 11/06/2006 MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS MEDRAD, INC. LISA A EWING
K063401 11/09/2006 BANANA RIBBED MEDTECH PRODUCTS LTD. RAVI REDDY
K063510 11/20/2006 LIFEPAK 12 DEFIBRILLATOR/MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. MICHELLE ACKERMANN
K063417 11/13/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K063491 11/17/2006 T2 SCEPTOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SEIFERT
K063305 11/01/2006 STIMULATING BUR GUARD MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K063327 11/03/2006 ORTHOVIEW MERDIAN TECHNIQUE, LTD. ANTHONY THORNE
K063487 11/17/2006 MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE MERETE MEDICAL GMBH DONNA COLEMAN
K063542 11/24/2006 WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K063381 11/08/2006 CT COMPATIBLE F/S/D APPLICATORS MICK RADIO-NUCLEAR INSTRUMENTS, INC. FLEIX MICK
K063382 11/08/2006 HDR CT COMPATIBLE SPLIT RING APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K063338 11/06/2006 HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER MIMOSA ACOUSTICS, INC. PATRICIA S JENG
K063437 11/14/2006 ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 MONOBIND, INC. JAY SINGH
K063561 11/27/2006 MOORLDLS LASER DOPPLER LINE SCANNER MOOR INSTRUMENTS LTD. XIABING HUANG
K063439 11/13/2006 MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS MTD, INC. CHRISTINE NICHOLS
K063462 11/15/2006 NEATSTITCH NEATCLOSE SUTURING DEVICE NEAT STITCH LTD. YOSSI MUNCHER, PH.D.
K063321 11/02/2006 D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 NEKS TECHNOLOGIES, INC. NAIM KARAZIVAN
K063368 11/07/2006 NIPRO BIOHOLE NEEDLE NIPRO MEDICAL CORP. JESSICA OSWALD
K063521 11/22/2006 NISSIN PEDIATRIC SERIES WHEELCHAIR NISSIN MEDICAL INC. TAKAHIRO HARUYAMA
K063539 11/24/2006 NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 NORDICICEMEDICAL AS JAMES W KNOX
K063549 11/24/2006 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K063345 11/06/2006 SPY IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K063477 11/16/2006 NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET NOVAMED, LLC PAUL DRYDEN
K063355 11/07/2006 D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW NOVOSCI CORP. DAVID MAKANANI
K063304 11/01/2006 LIFE4C NUMEDIS, INC. MARY E FREDDO
K063454 11/15/2006 POGS, MODEL 33C ON SITE GAS SYSTEMS, INC. GUY HATCH
K063330 11/03/2006 ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. HOWARD L SCHRAYER
K063395 11/09/2006 O&P BIVALVE CRANIAL MOLDING HELMET ORTHOTIC & PROSTHETIC LAB, INC. THOMAS L MALONE
K063298 11/01/2006 OSTEOMED HEADLESS CANNULATED SCREW SYSTEM OSTEOMED L.P. DAWN D TINDALL
K063350 11/06/2006 DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K063528 11/22/2006 TROCASYS PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K063571 11/29/2006 PALOMAR LUX2940 HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. Sharon Timberlake
K063559 11/27/2006 ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 PHILIPS MEDICAL SYSTEMS JOSEPH S ARNAUDO
K063375 11/08/2006 HEARTSTART MRX, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS DENISE HALEY
K063315 11/02/2006 INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH ANDREAS SUCHI
K063344 11/06/2006 CAAS QCA 3D PIE MEDICAL IMAGING B.V. CARLA DE VRIES
K063578 11/30/2006 PROMOS MODULAR SHOULDER SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K063556 11/27/2006 PERIPATCH ENDO-SLEEVE PM DEVICES, INC. TIM VERSPAGEN
K063408 11/13/2006 CTLOGICS NAVIGATIONS SYSTEMS PRAXIM MEDIVISION, SA MADY BATAILH
K063389 11/02/2006 GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
K063494 11/20/2006 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS PRO-MED INSTRUMENTS GMBH EDGAR SCHUELE
K063581 11/30/2006 SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE PT MAHAKARYA INTI BUANA V. NADARAJAN
K063405 11/09/2006 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL SCOTT A WILSON
K063294 11/01/2006 TOPACS RADIOLOGICAL SPECIALISTS, INC. FRANK MCMURRAY
K063434 11/13/2006 TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM RADIOMETER BASEL AG JEAN-PIERRE PALMA
K063548 11/24/2006 COR ANALYZER 1, VERSION 1.4 RCADIA MEDICAL IMAGING LTD. DAN LAOR
K063540 11/24/2006 BIPAP AUTOSV RESPIRONICS, INC. ZITA A YURKO
K063533 11/22/2006 BIPAP SYNCHRONY RESPIRONICS, INC. ZITA A YURKO
K063520 11/21/2006 ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS Roche Diagnostics KERWIN KAUFMAN
K063543 11/24/2006 COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 ROCHE DIAGNOSTICS CORP. CORINA HARPER
K063340 11/06/2006 SAF-T-SYRINGE- 0.5 AND 1ML/CC SAFETY MEDICAL INTERNATIONAL, INCORPORATED FRAN WHITE
K063391 11/09/2006 SAPHENEIA CLARITY SAPHENEIA COMMERCIAL PRODUCTS AB RICK MANCILLA
K063497 11/20/2006 MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. RALPH ZIMMERMAN
K063499 11/20/2006 MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. RALPH ZIMMERMAN
K063498 11/20/2006 HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) SEBIA KAREN ANDERSON
K063310 11/02/2006 TRUEFIELD ANALYZER SEEING MACHINES LIMITED ALAN DONALD
K063302 11/01/2006 SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES SHANGHAI DENTAL INSTRUMENT FACTORY MARK JOB
K063334 11/06/2006 SHANGHAI GANGHAI MODEL GIKO 1400 SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. JOSEPH Z ZDROK
K063407 11/09/2006 BC-3200 AUTO HEMATOLOGY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K063500 11/20/2006 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN GOLDSTEIN-FALK
K063471 11/16/2006 SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG JUNFEI PLASTIC PRODUCTS CO., LTD. KC CHEUNG
K063373 11/08/2006 FLEX LOOP COIL SET 3T SIEMENS AG RUTH SCHNEISS
K063507 11/20/2006 SYNGO NEURO PBV CT SIEMENS AG RALF HOFMANN
K063535 11/22/2006 CAPTION APPLICATOR SMITH & NEPHEW, INC. KIM P KELLY
K063450 11/15/2006 PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K063459 11/15/2006 CRANEX NOVUS SOREDEX PALODEX GROUP OY KAI LANER
K063490 11/17/2006 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 SPACELABS MEDICAL INC. DAVID J GERAGHTY
K063431 11/13/2006 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 SPIRE BIOMEDICAL INC SHEKHAR D NIMKAR
K063441 11/14/2006 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 SPIRE BIOMEDICAL INC SHEKHAR NIMKAR
K063531 11/22/2006 SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM SRA DEVELOPMENTS, LTD. MICHAEL J.R. YOUNG
K063385 11/08/2006 DUREX PLAY MASSAGE GEL LUBRICANT SSL AMERICAS, INC. CHRIS ROBINSON
K063480 11/17/2006 STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 STRYKER CORP. JEAN SHEPPARD
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K063568 11/28/2006 HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL SUZHOU MEDICAL APPLIANCE FACTORY HENRY WOO
K063489 11/17/2006 STRYKER INTRADISCAL RF GENERATOR SYNERGETICS, INC. DAN REGAN
K063473 11/16/2006 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K063352 11/06/2006 ELLEX SLIT LAMP, MODEL 30XL TAKAGI SEIKO CO., LTD. KEVIN HOWARD
K063438 11/14/2006 VSPSPN TECRES SPA CHRISTINE BRAUER
K063372 11/08/2006 RADIFOCUS GLIDEWIRE ADVANTAGE TERUMO MEDICAL CORP. MARK UNTERREINER
K063388 11/08/2006 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM TOPCON CORP. JONATHAN S KAHAN
K063456 11/15/2006 SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM TOPEX, INC ANTHONY PELLEGRINA
K063551 11/24/2006 AEQUALIS HUMERAL PLATE TORNIER Mireille Lemery
K063361 11/07/2006 EXCELART VANTAGE ATLAS, MODEL MRT-1503 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K063309 11/02/2006 TRU-CABLE TRUPHATEK INTERNATIONAL, LTD. PAUL DRYDEN
K063536 11/22/2006 POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING TYCO HEALTHCARE GROUP ROBERT ZOTT
K063416 11/13/2006 LUXVISION SLIT LAMP U.S. OPHTHALMIC LLC AL WEISENBORN
K063557 11/27/2006 PEAK BOND, MODEL 5133 ULTRADENT PRODUCTS, INC. DIANE ROGERS
K063558 11/27/2006 PEAK SE, MODEL 5135 ULTRADENT PRODUCTS, INC. DIANE ROGERS
K063371 11/08/2006 PRONTO V3 EXTRACTION CATHETER, MODEL 5003 VASCULAR SOLUTIONS, INC. JULIE TAPPER
K063567 11/28/2006 EZ-MIO STERNAL VIDACARE CORPORATION GRACE HOLLAND
K063337 11/06/2006 OPAL-RAD VIZTEK, INC. CARL ALLETTO
K063554 11/27/2006 MERON PLUS VOCO GMBH MICHAEL SUS
K063435 11/13/2006 GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC. Michael Ivey
K063367 11/07/2006 45L CORE INSUFFLATOR, MODEL F114 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K063386 11/08/2006 LORENZ ORTHODONTIC ANCHORAGE SYSTEM WALTER LORENZ SURGICAL, INC. KIM REED
K063506 11/20/2006 LORENZ STERNAL CLOSURE SYSTEM WALTER LORENZ SURGICAL, INC. KIM REED
K063419 11/13/2006 MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) WELCH ALLYN PROTOCOL, INC. JEFFREY WAGNER
K063547 11/24/2006 CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM WITT BIOMEDICAL CORP JAMES LUKER
K063560 11/28/2006 HILGER DUAL-STIM NERVE STIMULATOR WR MEDICAL ELECTRONICS CO. Gary Syring
K063523 11/22/2006 ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 ZIMMER DENTAL INC. ERIN MCVEY
K063303 11/01/2006 UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS ZIMMER, INC. ANTHONY FRANCALANCIA


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