FDA 510(k) Applications Received During September, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K052638 09/27/2005 ABBOTT SPINE, INC. SPINNAKER SYSTEM ABBOTT SPINE, INC. LISA PETERSON
K052566 09/19/2005 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY ABBOTT SPINE, INC. NOAH BARTSCH
K052454 09/06/2005 THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR DEVICES DEBBIE COGAN
K052732 09/30/2005 ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P ABRACAIR, INC. DAVID CHANGARIS
K052744 09/30/2005 C2000 AUTOMATED MANIFOLD KIT ACIST MEDICAL SYSTEMS, INC. A; SAALABI
K052418 09/08/2005 AXXESS BUTTERFLY ANCHOR ADVANCED NEUROMODULATION SYSTEMS STEVE TAMSETT
K052374 09/08/2005 RAPID PROGEAMMER 3.0 ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K052439 09/06/2005 AESKULISA GLIA A AND AESKULISA GLIA G AESKU.DIAGNOSTICS STANLEY AMMONS
K052762 09/30/2005 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX INC CONNIE HERTEL
K052697 09/28/2005 HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL AKERS BIOSCIENCES, INC. BARBARA A BAGBY
K052703 09/28/2005 ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL ALDEN OPTICAL LABS., INC. CHARLES H CREIGHTON
K052603 09/21/2005 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K052414 09/02/2005 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K052733 09/29/2005 ALMITECH INC. DENTAL IMPLANT SYSTEM ALMITECH INC. ALEX BREYTMAN
K052527 09/12/2005 NEUROPROBES ALPHA OMEGA ENGINEERING, LTD. SHLOMO PUNDAK
K052443 09/08/2005 ICY CATHETER, MODEL IC-3893A ALSIUS CORP. KENNETH A COLLINS
K052544 09/15/2005 PULSE OXIMETER ADAPTER CABLES AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K052537 09/15/2005 CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 AMERICAN MEDICAL SALES, INC. CAROL M LIFLAND
K052647 09/28/2005 CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. AMERICAN SPINE CENTER, LTD. JAMES WHITE
K052548 09/16/2005 UROK ROCKING WHEELCHAIR, MODEL 700-4XX AMG MEDICAL INC. KENNETH LEVESQUE
K052447 09/07/2005 SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 ANALOGIC CORP. DONALD SHERRATT
K052708 09/29/2005 PYLO-PLUS ARJ MEDICAL, INC. PHILIP ROSS
K052719 09/29/2005 URITEST 10 URINALYSIS REAGENT STRIPS ARJ MEDICAL, INC. AARON BEHAR
K052387 09/01/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC. ANN WATERHOUSE
K052607 09/22/2005 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS ARTHREX, INC. ANN WATERHOUSE
K052736 09/30/2005 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT ARTHREX, INC. ANN WATERHOUSE
K052614 09/23/2005 LOW PROFILE PLATE AND SCREW SYSTEM ARTHREX, INC. SALLY FOUST
K052686 09/28/2005 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K052482 09/09/2005 ARTELON SURGICAL SUTURE ARTIMPLANT AB MARIE MARLOW
K052667 09/27/2005 ARTSANA PISTON AND INSULIN SYRINGES ARTSANA S.P.A. LARA N SIMMONS
K052666 09/27/2005 NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN ASCEND EAGLE, INC. JARILYN LIM
K052541 09/21/2005 MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM AVANT MEDICAL SYSTEMS DANIEL KAMM
K052491 09/13/2005 AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K052393 09/01/2005 B. BRAUN MODIFIED BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052352 09/08/2005 COLOR CORONIS 2MP-21 AND MFCD 2321 BARCOVIEW LIEVEN DE WANDEL
K052403 09/08/2005 CORONIS 2MP-21" AND MFGD 2621 BARCOVIEW LIEVEN DE WANDEL
K052429 09/08/2005 CORONIS 3MP-21 AND MFGD 3621 BARCOVIEW LIEVEN DE WANDEL
K052529 09/15/2005 E-2320 PA S BARCOVIEW LIEVEN DE WANDEL
K052478 09/12/2005 MFCD 1219, MFCD 1219 TS BARCOVIEW LIEVEN DE WANDAL
K052578 09/20/2005 BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K052503 09/14/2005 TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K052481 09/09/2005 BD VIPER SYSTEM BECTON, DICKINSON & CO. COLLEEN A KISTLER
K052547 09/16/2005 BELMONT BUDDY FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K052457 09/07/2005 PICSI SPERM SELECTION DEVICE BIOCOAT, INC. JAMES B JOHNSTON
K052419 09/02/2005 MAXIMUS 3.0 AND OS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K052656 09/26/2005 VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K052639 09/26/2005 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER BIOMET MANUFACTURING, INC. SUSAN ALEXANDER
K052685 09/28/2005 ORTHOPEDIC SALVAGE SYSTEM- OSS BIOMET, INC. ALLISON KOSKEY
K052625 09/23/2005 BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, INC. KENT HOFFMAN
K052596 09/21/2005 MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 BIOPRO, INC. DAVID MRAK
K052433 09/06/2005 PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM BIOPTICS, INC. JEFFREY ORACH
K052646 09/28/2005 BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K052742 09/30/2005 HEPASPHERE MICROSPHERES BIOSPHERE MEDICAL, INC. ROSINA ROBINSON
K052757 09/30/2005 PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BIOTRONIK AG JON BRUMBAUGH
K052608 09/22/2005 TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) BL HEALTHCARE, INC. MICHAEL MATHUR
K052456 09/07/2005 MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED JASPER BENKE
K052517 09/14/2005 SITE-RITE 5 ULTRASOUND SYSTEM C.R. BARD, INC. KIMBERLY GEISLER
K052556 09/16/2005 CG-7000DX-BT ECG RECORDER/TRANSMITTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K052570 09/19/2005 TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 CARDIAC ASSIST, INC. TIM KRAUSKOPF
K052568 09/19/2005 ESTEEM STRETCHY VINYL GLOVE WITH COATING CARDINAL HEALTH AMY HOYD
K052598 09/21/2005 IMMOCARE CARE DIAGNOSTIC, INC. ARACELI FANCHER-FERREIRA
K052455 09/07/2005 IMPRESSIX CAVEX HOLLAND B.V. RICHARD WOORTMAN
K052643 09/26/2005 EPICERAM CERAGENIX CORPORATION CARL GENBERG
K052528 09/14/2005 AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE CEREMED, INC. TADEUSZ WELLISZ
K052725 09/29/2005 PROTECTOR NEEDLE SHEATH PROP CERTOL INTERNATIONAL, LLC LEWIS WARD
K052591 09/21/2005 NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT CLINICAL DATA, INC. ISRAEL M STEIN
K052679 09/28/2005 CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E CLINIQA CORPORATION CAROL RUGGIERO
K052449 09/06/2005 CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 CODMAN & SHURTLEFF, INC. JOAN Q BARTLE
K052740 09/30/2005 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K052448 09/08/2005 POCKET BREATHALYZER. CONNECTABLES CONNECTABLES, LLC PHILLIP H CORSE
K052539 09/15/2005 COOK FORMULA 418 BILIARY STENT SYSTEM COOK, INC. KAREN BRADBURN
K052560 09/16/2005 BIOFINITY (COMFILCON A) SOFT CONTACT LENS COOPERVISION, INC. JACK P DOUGLAS
K052501 09/13/2005 MULTIPLE RESIN TOOTH BONDING AGENT COSMEDENT, INC. JAMES L SANDRIK
K052696 09/28/2005 COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING COVALON TECHNOLOGIES LTD. JACQUES LEMMETTI
K051842 09/23/2005 GREEN LOVE MALE CONTRACEPTIVE (CONDOM) CUPID CONDOM, LTD. K.K. GOYAL
K052558 09/16/2005 VCS, MODEL S4T CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC CHANG W LAN
K052525 09/14/2005 CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS D.F.I. CO LTD ASAD R ZAIDI
K052496 09/16/2005 PRIMECHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K052534 09/22/2005 TACAHE DALTON MEDICAL CORP. WILL RIDGWAY
K052688 09/28/2005 ELLIPSE FLEX PPT, MODEL 9ESF7255 DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K052759 09/30/2005 DAN MONOPOLAR LAP ACCESSORIES DANNORITZER MEDIZINTECHNIK GMBH & CO. KG ANGELIKA SCHERP
K052498 09/12/2005 FRAGMENT SPECIFIC FIXATOR DAVID J. SLUTSKY MD DAVID J SLUTSKY
K052731 09/29/2005 KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES DAXIN LI YINGCHAO XIAO
K052513 09/14/2005 BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 DELTA ENTERPRISE CORPORATION MARIA E CELIS
K052532 09/15/2005 IMAX 9.5 STERILIZERS DENTAL X SRL CYNTHIA J.M. NOLTE
K052593 09/21/2005 FUSION CURING LIGHT DENTLIGHT INC. RICHARD LIU
K052436 09/07/2005 PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 DENVER BIOMEDICAL, INC. JEFF HILL
K052630 09/26/2005 ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K052631 09/26/2005 SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K052472 09/08/2005 DEPUY GLOBAL SHOULDER CROSSLINK GLENOID DEPUY ORTHOPAEDICS, INC. NATALIE HECK
K052546 09/16/2005 AEGIS ANTERIOR LUMBAR PLATE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K052746 09/30/2005 CONCORDE VBR SPINAL SYSTEM DEPUY SPINE, INC. LISA GILMAN
K052552 09/16/2005 HYBRID ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. LIZ LAVELLE
K052536 09/19/2005 ALGICELL AG DERMA SCIENCES CANADA, INC. DELA SHARMINI ATHERAY
K052551 09/16/2005 DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE DEVON SAFETY PRODUCTS, INC. BARRY L BERLER
K052499 09/14/2005 DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS DIASORIN S.P.A. MARI A MEYER
K052717 09/29/2005 D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER DIDECO S.R.L. BARRY SALL
K052430 09/06/2005 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. JOEL TUCKEY
K052705 09/28/2005 DART-12 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K051573 09/06/2005 TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) DR. HOWARD MARTIN, P.A. KYLE H SIBINOVIC
K052649 09/26/2005 DRG SLV TESTOSTERONE ELISA TEST DRG INTL., INC. GARY LEHNUS
K052445 09/07/2005 DUOPROSS NEEDLE DUOPROSS MEDITECH CORPORATION FRANK FERGUSON
K052754 09/30/2005 WRIST FUSION PLATE DVO EXTREMITY SOLUTIONS, LLC DINA L WEISSMAN
K052611 09/26/2005 ECP HEALTH SYSTEM, MODEL 2005 ECP HEALTH INC. SHAMON HUANG
K052661 09/27/2005 QUIX DIGITAL RADIOGRAPHIC UPGRADE EDGE MEDICAL DEVICES LTD. VERED SCHARF
K052438 09/06/2005 EMG HANDLE NEBULIZER NB02 SERIES EMG TECHNOLOGY CO., LTD. GENE R KULON
K052711 09/29/2005 EMJOI TENS DEVICE EMJOI, INC. MIKE JUDGE
K052479 09/09/2005 MBATH 1000 (60") ENNEKING MEDICAL INC. STEPHEN WHITTENBURG
K052549 09/16/2005 LEADCARE II BLOOD LEAD TESTING SYSTEM ESA BIOSCIENCES INC. HAROLD ASP
K052401 09/01/2005 GYNECARE TVT SECUR SYSTEM ETHICON, INC. PATRICIA M HOJNOSKI
K052659 09/27/2005 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC GLEN D SMYTHE
K052453 09/07/2005 TRACTION SYSTEM, DIGIT-TRAC 930 EVER PROSPEROUS INSTRUMENT, INC. KE-MEN JEN
K052714 09/29/2005 RAVE COMPOSITE BRACKET FDA AGENTS STEVE KLAMIC
K052642 09/26/2005 SUTURING WASHER FIRST CALL, INC. DINA L WEISSMAN
K052407 09/02/2005 ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS FISHER DIAGNOSTICS M. HEATHER CAMERON
K052422 09/02/2005 THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) FLOW X-RAY CORP. SUSAN D GOLDSTEIN-FALK
K052531 09/15/2005 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD. KEVIN WALLS
K052530 09/14/2005 SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA GALIL MEDICAL LTD. JONATHAN S KAHN
K052462 09/12/2005 G-COAT GC AMERICA, INC. TERRY L JORITZ-LYONS
K052582 09/20/2005 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052412 09/02/2005 INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE HEALTHCARE LARRY A KROGER
K052434 09/06/2005 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS ELI WERNER
K052581 09/20/2005 LUNAR IDXA GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES P RASKOB
K052441 09/06/2005 GE LOGIQ 7 ULTRASOUND BT05 GENERAL ELECTRIC CO. ALLEN SCHUH
K052565 09/22/2005 ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF GENESEE BIOMEDICAL, INC. JOHN T. M. WRIGHT
K052745 09/30/2005 ASSISTO ARM SYSTEMS GEOMED MEDIZIN-TECHNIK GMBH & CO. ANGELIKA SCHERP
K052605 09/23/2005 EXTERNAL FIXATION GEXFIX USA INC. LUCIO IMPROTA
K052617 09/23/2005 FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, GOOD BIOTECH CORP. VICTOR CHIOU
K052665 09/27/2005 GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES GRANTON MEDICAL LTD. CYNTHIA J.M. NOLTE
K052420 09/08/2005 G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM GYNOVA, LLC DON GUINAN
K052626 09/23/2005 SMARTSUCTION HARMONY DEVICE HAEMONETICS CORP. GABRIEL J MURACA
K052416 09/07/2005 PERIPRO PATCH HANCOCK/JAFFE LABORATORIES SUE MONTOYA
K052480 09/09/2005 HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH HANSEN MEDICAL, INC. NINA PELED
K052583 09/22/2005 BLUE POWDER FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD KUAN KAM HON
K052471 09/08/2005 HDC SPIDER SCREW HDC S.R.L. MILLIE LYNN BENTLEY
K052469 09/21/2005 GLUCOPACK HEALTHPIA AMERICA CORP. STEVEN KIM
K052465 09/08/2005 REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 HEARTSINE TECHNOLOGIES, INC. GEORGE BRDLIK
K052723 09/29/2005 SEVEN STAR NEEDLE HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K052543 09/16/2005 HERACERAM ZIRKONIA HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K052446 09/07/2005 LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM HOANA MEDICAL, INC. MATTHEW S GLEI
K052671 09/27/2005 HOCA EZ-CARE BP108, TENDER-CARE BP109 HOCA MEDICAL MICROSYSTEM, INC. JEN KE-MIN
K052597 09/21/2005 BREATHEX OMEGA CPAP DEVICE, MODEL 322 HOFFMAN LABORATORIES, LLC KEITH BOSECKER
K052722 09/29/2005 LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS HOSPIRA, INC. THOMAS KOZMA
K052748 09/30/2005 SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K052718 09/29/2005 V40 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K052594 09/21/2005 WILLCARE, MODEL GW-1020 ICU MEDICAL INC SCOTT NELSON
K052618 09/23/2005 IMAGECAST PACS IDX SYSTEMS CORP. ROSINA ROBINSON
K052577 09/23/2005 IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM IKONISYS INC S. MICHAEL SHARP
K052648 09/26/2005 MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS IMPLANT INNOVATIONS, INC. JIM BANIC
K052505 09/15/2005 CALF IMPLANT, MODEL EC17-X IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K052504 09/15/2005 GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K052662 09/28/2005 ONE STEP FSH MENOPAUSAL TEST IND DIAGNOSTIC INC. JASON PENG
K052694 09/28/2005 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. IND DIAGNOSTIC INC. JASON PENG
K052545 09/15/2005 INFINITT G3 PACS INFINITT CO., LTD. CARL ALLETTO
K052444 09/06/2005 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. HANNA MARTTILA
K052624 09/23/2005 INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE INION LTD. HANNA MARTTILA
K052663 09/27/2005 INO THERAPEUTICS INOBLENDER, MODEL 10004 INO THERAPEUTICS FREDERICK MONTGOMERY
K052468 09/08/2005 YK9000 SERIES MANUAL WHEELCHAIR INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. JOHN ZHAO
K052473 09/09/2005 CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 INTER MEDICAL MEDIZINTECHNIK GMBH HANS GUENTER OSIEK
K052562 09/28/2005 ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. INTERACOUSTICS AS DANIEL EGGAN
K052550 09/16/2005 IMC SURGICAL GOWNS INTL. MEDSURG CONNECTION, INC. MANNY GUPTA
K052704 09/29/2005 MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE INVIVO CORP. THOMAS E TYNES
K052497 09/12/2005 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A INVIVO CORP. TOM SCHUBERT
K052404 09/07/2005 DENALI DEFORMITY SYSTEM K2M, LLC RICHARD W WOODS
K052398 09/07/2005 MESA SPINAL SYSTEM K2M, LLC RICHARD W WOODS
K052673 09/27/2005 KING I POWERED SCOOTER, MODEL CTL-11 KING I TECH CORPORATION KE-MIN JEN
K052676 09/27/2005 KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K052450 09/07/2005 KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K052561 09/22/2005 TERUMO MICRO TAPERED PEN NEEDLE KOFU FACTORY OF TERUMO CORP. BARBARA SMITH
K052467 09/08/2005 BRAIN VIEWRX VIEWER, VERSION 1.0 KYRON CLINICAL IMAGING, INC. JAMES L REUSS
K052610 09/27/2005 IMAGE STAR II LAKESHORE TECHNOLOGIES INC. JACK RACE
K052604 09/21/2005 STARLITE 2006 LASER DENTAL INNOVATIONS HOWARD FEINBERG
K052767 09/30/2005 AFIBALERT ATRIAL FIBRILLATION DETECTOR LECHNOLOGIES RESEARCH INC. TIM LOHMAN
K052735 09/30/2005 ALLOCRAFT DBM LIFECELL CORP. HOWARD M HOLSTEIN
K052678 09/28/2005 AQ-830 SLIM BODY, BODY FAT MONITOR LIMAX ELECTRONICS CO., LTD. JENNIFER REICH
K052458 09/07/2005 LIV MEDICA CPR FACE MASK LIV MEDICA PRODUCTS PVT. LTD. MICHAEL HOLSTEIN
K052715 09/29/2005 CALM CURVE, VERSION 01.00 LMS MEDICAL SYSTEMS (CANADA), LTD. PAMELA HASWELL
K052526 09/15/2005 NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES LUMENIS, INC. KAREN L BAKER
K052728 09/29/2005 POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES M/S. KANAM LATEX INDUSTRIES PVT. LTD. RAVI ABRAHAM
K052622 09/27/2005 MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT MACAN ENGINEERING CO. MICKEY ALBERGO
K052606 09/27/2005 MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS MARIETTA VISION MARTIN DALSING
K052563 09/19/2005 INOGEN SATELLITE CONSERVER, MODEL SC-100 MEDICAL ELECTRONIC DEVICES, INC. THOMAS WENZEL
K052495 09/12/2005 ATRILAZE MALLEABLE ABLATION PROBE MEDICALCV, INC. DENNY STEGER
K052424 09/07/2005 MAXILIM MEDICIM NV JOSEPH AZARY
K052751 09/30/2005 VENTLINK SYSTEM MEDISERVE INFORMATION SYSTEMS, INC. MARK OFORI-KYEI
K052615 09/23/2005 MEDISIZE GOLD MEDISIZE BV SOPIHA LAM
K052674 09/27/2005 CONTACT LENS OPHTHALMODYNAMOMETER MEDITRON, GMBH ROBERT N CLARK
K052720 09/29/2005 MEDLINE IODOFORM PACKING STRIPS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K052431 09/06/2005 MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 MEDTRONIC MINIMED JODIE ROGERS
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K052683 09/28/2005 SYNTHES (USA) STERNAL FIXATION SYSTEM SYNTHES (USA) LISA BOYLE
K052677 09/29/2005 SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) SYNTHES (USA) SHERI L MUSGNUNG
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K052660 09/28/2005 MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO THE RICHMOND LIGHT CO. ALEX M CLARKE
K052637 09/26/2005 THEROX INFUSION CATHETER, MODEL INCA-1 THEROX, INC. DAVID W MULLIS JR.
K052520 09/14/2005 RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC TIANJIN NEW BAY BIORESEARCH CO., LTD. RODRIGO BERLIE
K052557 09/16/2005 SUPER SHEATH INTRODUCER SHEATH TOGO MEDIKIT CO., LTD. HEIDI M ERICKSON
K052584 09/20/2005 1.5T 12 CHANNEL BODY ARRAY USA INSTRUMENTS, INC. ROBERT B SMITH
K052621 09/23/2005 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL USA INSTRUMENTS, INC. ROBERT B SMITH
K052585 09/20/2005 3T HD BREAST ARRAY USA INSTRUMENTS, INC. DAVID BROWN
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K052408 09/02/2005 EZ-IO VIDACARE CORPORATION GRACE HOLLAND
K052710 09/29/2005 VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, VIDENT BARBARA J LEWANDOWSKI
K052682 09/28/2005 ALIGNRT VISION RT LIMITED NORMAN SMITH
K052632 09/26/2005 VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE VITAL IMAGES, INC. TIMOTHY J KAPPERS
K052395 09/02/2005 STERILE EQUIPMENT COVERS VOLCANO CORPORATION MICHELLE J BADAL
K052564 09/19/2005 VYGON LEADER-FLEX VYGON CORP. COURTNEY SMITH
K052475 09/09/2005 VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS VYGON US LLC COURTNEY SMITH
K052559 09/16/2005 WU'S POWERED WHEELCHAIR, MAMBO 2 WU'S TECH CO., LTD. JEN KE-MIN
K052502 09/13/2005 NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES YTY INDUSTRY (MANJUNG) SDN. BHD. JANNA P TUCKER
K052600 09/21/2005 ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) ZIMMER DENTAL INC. ERIN MCVEY
K052425 09/02/2005 ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION ZIMMER, INC. STEPHEN H MCKELVEY


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