FDA 510(k) Applications Received During October, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K013535 10/23/2001 EVTOOL MODEL # V. 1.0 3D LINE USA, INC. KAREN RIGAMONTI
K013491 10/22/2001 HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 A & A MEDICAL, INC. JAY MANSOUR
K013437 10/17/2001 SF SH CATHETER, MODEL R65-945 A & A MEDICAL, INC. JAY MANSOUR
K013393 10/15/2001 HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H A-MED SYSTEMS, INC. CYNTHIA G ROYSTER
K013538 10/24/2001 ETHANOL ABBOTT LABORATORIES ALICIA SIMPSON
K013314 10/04/2001 OPIATES ABBOTT LABORATORIES ALICIA SIMPSON
K013596 10/31/2001 MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) ACCUMETRICS, INC. RHONDA MOE
K013380 10/12/2001 ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K013511 10/22/2001 XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) ACULUX, INC. KIM MARSH
K013521 10/23/2001 GEMINI IMAGING SYSTEM ADAC LABORATORIES COLEEN A COLEMAN
K013496 10/22/2001 MODIFICATION TO SKYLIGHT IMAGING SYSTEM ADAC LABORATORIES DAVID KOLESAR
K013291 10/02/2001 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) ADVANCED DIAGNOSTICS, INC. STEVE HESLER
K013569 10/29/2001 ORTHOPILOT 2 AESCULAP, INC. GEORG KELLER
K013302 10/03/2001 DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K013479 10/19/2001 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K013396 10/15/2001 ALPHA DRIVE SYSTEM ALPHA OMEGA LTD. AJWAD AKASHI
K013318 10/05/2001 ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 AMERICAN DIAGNOSTICA, INC. JOHN BERRYMAN
K013492 10/22/2001 IMUBIND TPA ELISA, MODEL 860 AMERICAN DIAGNOSTICA, INC. JOHN B BERRYMAN
K013355 10/10/2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. GINGER S GLASER
K013604 10/31/2001 MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K013603 10/31/2001 MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K013320 10/05/2001 BLUE LATEX EXAMINATION GLOVES, POWDER FREE ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K013433 10/16/2001 TROJAN PASSION BERRY GEL ARMKEL LLC STEPHEN C KOLAKOWSKY
K013334 10/09/2001 ENDOFLIP ARTHOCARE CORPORATION NICK WOODS
K013463 10/18/2001 ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND ARTHROCARE CORP. BRUCE PROTHRO
K013418 10/15/2001 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY ASAHI MEDICAL CO., LTD DAVID L WEST
K013577 10/29/2001 ULTRAMAX WOVEN VELOUR VASCULAR GRAFT ATRIUM MEDICAL CORP. JOSEPH P PAOLO
K013298 10/03/2001 RETROX AURIC HEARING SYSTEMS, INC. DAVID J NAVAROLI
K013420 10/15/2001 CHEMWELL, ALSO KNOWN AS PROJECT 2900 AWARENESS TECHNOLOGY, INC. GLEN VAN SLOOTEN
K013532 10/17/2001 ULTRASTIM KIT AXELGAARD MFG. CO., LTD. DAN JEFFERY
K013587 10/30/2001 BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS BABIES BEST, INC. JAY SALKIN
K013562 10/26/2001 AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K013272 10/01/2001 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY BAYER CORP. KENNETH T EDDS
K013568 10/26/2001 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP. KENNETH T EDDS
K013606 10/31/2001 ACS 180 HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K013406 10/15/2001 ADVIA CENTAUR HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K013304 10/04/2001 BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K013383 10/12/2001 BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM BIOMEDICAL IMPLANT TECHNOLOGY, INC. RODNEY J SHAUGHNESSY
K013534 10/23/2001 SELF-COUNTERSINKING BONE SCREW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K013546 10/24/2001 MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 BIONX IMPLANTS, INC. TUIJA ANNALA
K013289 10/02/2001 BIOTEQUE VAGINAL PESSARIES BIOTEQUE AMERICA, INC. DENIS DORSEY
K013519 10/23/2001 SIMPLE BISCO, INC. STEPHEN D SMITH
K013558 10/25/2001 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K013598 10/31/2001 REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES C.R. BARD, INC. EBORAH L HERRINGTON
K013565 10/26/2001 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 CAMBRIDGE HEART, INC. JOHN GREENBAUM
K013564 10/26/2001 MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS CAMBRIDGE HEART, INC. JOHN GREENBAUM
K013593 10/30/2001 CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K013354 10/09/2001 GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. ANGELA HALWAS
K013305 10/04/2001 ENOXAPARIN TEST CARD CARDIOVASCULAR DIAGNOSTICS, INC. PETER SCOTT
K013402 10/15/2001 VISULAS 532S CARL ZEISS, INC. KENNETH M NICOLL
K013336 10/09/2001 XANTALGIN CRONO CAVEX HOLLAND B.V. RICHARD WOORTMAN
K013472 10/18/2001 TOTAL O2 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K013342 10/09/2001 EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. CHAY MEDICAL, LLC. STEPHEN C PEARSON
K013458 10/18/2001 CRANIAL HELMET CHILDREN'S HOSPITAL CONNIE FICKLIN
K013512 10/22/2001 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K013332 10/09/2001 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K013480 10/19/2001 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC. SHAWN RIEDEL
K013434 10/16/2001 VP-2000/1000 COLIN CORP. KENICHI SAKURADO
K013525 10/23/2001 CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) COLOPLAST CORP. HARVEY M ARBIT
K013400 10/15/2001 SYNERGY FLOW COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K013551 10/24/2001 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM COMPUTER MOTION, INC. DAVID U THOMAS
K013574 10/29/2001 ACCENT CONFIRMA, INC. CHERYL SHEA
K013597 10/31/2001 TAMPONADE UTERINE BALLOON CATHETER SET COOK OB/GYN CINDY RUMPLE
K013581 10/29/2001 CORDIS AVIATOR PERIPHERAL DILATATION CATHETER CORDIS, A JOHNSON & JOHNSON CO. CHUCK RYAN
K013507 10/22/2001 COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH COSMO HEALTH INC. ROBERT SCHIFF
K013274 10/01/2001 MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE CP MEDICAL MARY ANN GREENAWALT
K013504 10/22/2001 MODIFICATION TO: ECAT LSO PET/CT SCANNER CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K013423 10/02/2001 MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K013452 10/18/2001 DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS DANMAR PRODUCTS, INC. KAREN A LINDNER
K013326 10/05/2001 MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B DATASCOPE CORP. JOANN WOLF
K013389 10/12/2001 DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K013387 10/12/2001 DATEX-OHMEDA S/5 WEB VIEWER DATEX-OHMEDA JOEL KENT
K013359 10/10/2001 LP(A)-LATEX SEIKEN ASSAY KIT DENKA SEIKEN'S YOUSUKE MEGURO
K013441 10/17/2001 ISOLA POLYAXIAL WASHER DEPUY ACROMED LISA GILMAN
K013382 10/12/2001 MODIFICATION TO: STACKABLE CAGE SYSTEM DEPUY ACROMED KAREN F JURCZAK
K013294 10/02/2001 MONARCH SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013296 10/02/2001 MOSS MIAMI SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013295 10/02/2001 TIMX SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013430 10/16/2001 ACE BIO WIN TIBIAL NAILING SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013563 10/26/2001 LONG TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013350 10/09/2001 MODIFICATION TO DEPUY C-STEM SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013503 10/22/2001 MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013352 10/09/2001 SUMMIT CEMENTED HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013465 10/18/2001 ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT DIABETES TECHNOLOGIES, INC. ARTHUR G WILLIAMS
K013566 10/26/2001 IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K013499 10/22/2001 DIOMED 15 PLUS AND DIOMED 30PLUS LASERS DIOMED, INC. MARY MCNAMARA-CULLINANE
K013449 10/17/2001 MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K013571 10/29/2001 MAGICFIL DMG USA, INC. PAMELA PAPINEAU
K013271 10/01/2001 DXS DIGITAL X-RAY SYSTEM DOUGLAS C. YOON, DDS DOUGLAS C YOON
K013361 10/10/2001 WIN-2 TANGO ELITE NP DURABLE MEDICAL EQUIPMENT, INC. ROBERT S MCQUATE
K013471 10/18/2001 "DELTA 2000" SERIES EXTRACORPOREAL LITHOTRIPTER E.S.W.L. PRODUCTS, INC. DANIEL KAMM
K013540 10/24/2001 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P. MICHAEL TAGGART
K013378 10/12/2001 EBI XFIX DFS SYSTEM EBI, L.P. MICHAEL T TAGGART
K013490 10/22/2001 CEMENTED CALCAR HIP SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K013431 10/16/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K013442 10/17/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K013403 10/15/2001 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K013349 10/09/2001 ASTRONOMER PLUS SYSTEM EP TECHNOLOGIES, INC. ANDREA L RUTH
K013348 10/09/2001 MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 ERBE USA, INC. JOHN TARTAL
K013493 10/22/2001 INDIGO OPTIMA LASER SYSTEM ETHICON ENDO-SURGERY, INC. LINDA HILL
K013413 10/15/2001 MICROMARK II TISSUE MARKER,MODEL C1535 ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K013576 10/29/2001 PERICSCOPE, MODEL # PERISC1 ETHICON ENDO-SURGERY, INC. DOUG KENTZ
K013256 10/01/2001 BI-3M NEEDLE-FREE INJECTOR SYSTEM FELTON INTERNATIONAL, INC. ALAN FELTON
K013395 10/15/2001 LIFEJET VIDEO LINK FERRANIA S.P.A. ING. MANNELLA PAOLO
K013397 10/15/2001 PACIFIC HEMOSTASIS REFERENCE EMULSION FISHER DIAGNOSTICS JERALD P STEINER
K013445 10/17/2001 OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES FLORIDA OPTICAL ENGINEERING, INC. RICHARD A GRIFFIN
K013263 10/01/2001 FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST FRED HUTCHINSON CANCER RESEARCH CENTER SHELBY J HALL
K013438 10/17/2001 FRIALIT-2 ESTHETICBASE ABUTMENT FRIADENT GMBH CAROL PATTERSON
K013273 10/01/2001 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE FUKUDA DENSHI USA, INC. LARRY WALKER
K013448 10/17/2001 PRISMASATE GAMBRO RENAL PRODUCTS FEI LAW
K013422 10/15/2001 CARDIQ FUNCTION GE MEDICAL SYSTEMS STEVEN J KACHELMEYER
K013481 10/19/2001 DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION GE MEDICAL SYSTEMS JODI PARKER
K013561 10/26/2001 LIGHTSPEED 4.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K013533 10/23/2001 EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) GENERAL DEVICES MICHAEL SMITH
K013381 10/12/2001 ADVANCED LUNG ANALYSIS-1 GENERAL ELECTRIC CO. STEVEN J KACHELMEYER
K013446 10/17/2001 GLUSITE, MODEL GLU002 GLUSTITCH, INC. DON BLACKLOCK
K013262 10/01/2001 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES GREAT GLOVE (THAILAND) CO. LTD. KM LEE
K013536 10/23/2001 EMTRAC; DELPHIN; SEMTRAC 2000 SET GYNETICS MEDICAL PRODUCTS NV GRACE HOLLAND
K013497 10/22/2001 FAS SET #4551 GYNETICS MEDICAL PRODUCTS NV GRACE HOLLAND
K013501 10/22/2001 IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B GYNETICS MEDICAL PRODUCTS NV GRACE HOLLAND
K013424 10/15/2001 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND HAND INNOVATIONS, INC. AL WEISENBORN
K013573 10/29/2001 CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR S MASER
K013466 10/18/2001 SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 HELENA LABORATORIES PATRICIA FRANKS
K013376 10/11/2001 QFLOW 500 PERFUSION MONITORING SYSTEM HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K013483 10/19/2001 INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT HOLLISTER, INC. JOSEPH TOKARZ
K013345 10/09/2001 INCARE INTERMITTENT CATHETER HOLLISTER, INC. JOSEPH S TOKARZ
K013468 10/18/2001 LONG LENGTH DYAX NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K013475 10/19/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K013524 10/23/2001 TROCHANTERIC DYAX NAIL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K013462 10/18/2001 HYDROFERA BACTERIOSTATIC WOUND DRESSING HYDROFERA, LLC. HEATHER H BOND
K013461 10/18/2001 NLITE SYSTEM,MODEL A00-1025 ICN PHOTONICS LTD. MIKE KIERMAN
K013432 10/15/2001 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G IMMUNO CONCEPTS, INC. ERIC S HOY
K013285 10/02/2001 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 IMMUNO CONCEPTS, INC. ERIC S HOY
K013283 10/02/2001 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 IMMUNO CONCEPTS, INC. ERIC S HOY
K013531 10/23/2001 QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 IMPAC MEDICAL SYSTEMS, INC. THOMAS H FARIS
K013570 10/26/2001 OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K013333 10/09/2001 LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM INNOVATIVE GLOVES CO; LTD RAJEEV K SOOD
K013416 10/15/2001 INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY INTUITIVE SURGICAL, INC. MICHAEL YRAMATEGUI
K013516 10/23/2001 INVACARE ELEVATING SEAT OPTION ESS6 INVACARE CORP. RAE A FARROW
K013518 10/23/2001 EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K013275 10/01/2001 ASTRALIS 10, MODELS # 559588, 561859 IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K013277 10/02/2001 ASTRALIS 7, MODEL 557545 IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K013584 10/30/2001 EXCITE SELF ETCH IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K013543 10/17/2001 BOND-1 C & B JENERIC/PENTRON, INC. ANNMARIE TENERO
K013542 10/17/2001 DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) JENERIC/PENTRON, INC. ANNMARIE TENERO
K013401 10/15/2001 K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 K-SYSTEMS, KIVEX BIOTEC LTD. JACOB MOLLENBACH
K013500 10/22/2001 KAVO POLYLUX II KAVO AMERICA JENNIFER POTTALA
K013375 10/11/2001 BELLEGLASS HP OPAQUE 2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K013325 10/05/2001 POINT 4 FLOWABLE 2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K013537 10/23/2001 ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) KOON SENG SDN.BHD LIM WENG HENG
K013303 10/04/2001 CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER LATEXX MANUFACTURING SDN.BHD. TEOH CHOH SHEE
K013259 10/01/2001 PORTABLE NON-CONTACT TONOMETER, MODEL PT100 LEICA MICROSYSTEMS, INC. O.I.D. FRANK J DREXELIUS
K013421 10/16/2001 LIFEGUARD NASAL CPAP MASK AND ACCESSORIES LIFEGUARD MEDICAL PRODUCTS, INC. CRAIG JOHNSON
K013553 10/25/2001 PRE-LOADED ULTRAFIX RC LINVATEC CORP. LAURA D SENEFF
K013369 10/11/2001 RESECTION ABLATOR LINVATEC CORP. LAURA D SENEFF
K013290 10/02/2001 MODIFIED 650 MAMMOGRAPHY SYSTEM LORAD, A HOLOGIC CO. ROAIDA RIZKALLAH
K013284 10/02/2001 LUMEND FRONTRUNNER CTO CORONARY CATHETER LUMEND, INC. MICHAEL A DANIEL
K013265 10/01/2001 VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 MAINE STANDARDS CO. CHRISTINE BEACH
K013498 10/22/2001 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) MAXTER GLOVE MANUFACTURING SDN BHD STANLEY THAI
K013554 10/25/2001 POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) MAXTER GLOVE MANUFACTURING SDN BHD STANLEY THAI
K013443 10/17/2001 POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 MAXTER GLOVE MANUFACTURING SDN BHD STANLEY THAI
K013582 10/30/2001 MAYBE?MOM MINI OVULATION MICROSCOPE MAYBE?MOM TONI MILLERVA
K013366 10/10/2001 PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR MEDICAL BIO CARE SWEDEN AB CONNIE W HOY
K013365 10/10/2001 PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS MEDICAL BIO CARE SWEDEN AB CONNIE W HOY
K013391 10/15/2001 BODYFIX MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH CHRISTIAN MULLER
K013517 10/22/2001 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 MEDTRONIC VASCULAR KRISTY K MOLLNER
K013392 10/15/2001 CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 MEDTRONIC VASCULAR SCOTT CANDY
K013331 10/05/2001 LYMPHA PRESS PLUS DEVICE MEGO AFEK AHAVA STEIN
K013505 10/22/2001 AUROFLUID PLUS METALOR TECHNOLOGIES USA BRUCE BARTON
K013506 10/22/2001 YELLOW SPECIAL METALOR TECHNOLOGIES USA BRUCE BARTON
K013264 10/01/2001 MICRO STAMPING LIGATING CLIP MICRO STAMPING CORP. JOHN GAGLIARDI
K013485 10/19/2001 MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K013311 10/04/2001 MODIFICATION TO: POCKETVIEW ECG SOFTWARE MICROMEDICAL INDUSTRIES, LTD. STEPHEN CRESSWELL
K013297 10/03/2001 AIRCAST, MODEL #3011 MILLENIUM REPROCESSING SERVICES, INC. GARY J SFEIR
K013417 10/15/2001 MISONIX IRRIGATION SYSTEM MOEDL BC20P MISONIX, INC. ALBERT F CLANCY
K013572 10/29/2001 MITEK BIOCRYL INTERFERENCE SCREWS MITEK PRODUCTS CHRISTINE KUNTZ-NASSIF
K013258 10/01/2001 INPATH E2 COLLECTOR MOLECULAR DIAGNOSTICS ROBERT L HABIG
K013322 10/05/2001 HAC-420 HEAD ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K013602 10/31/2001 HNC-63-INT NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K013508 10/22/2001 HRH-127-ALLEGRA HEAD ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K013514 10/22/2001 PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K013399 10/15/2001 MODEL MES-9000/EMG SYSTEM MYOTRONICS-NOROMED, INC. FRAY ADIB
K013360 10/10/2001 DFINER UROLOGICAL CATHETER NEOSEED TECHNOLOGY,LLC MARK KIERAS
K013459 10/18/2001 MODIFICATION OF NC-STAT NEUROMETRIX, INC. SHIELA HEMEON-HEYER
K013419 10/15/2001 NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM NICOLET BIOMEDICAL DAVID W WAGNER
K013281 10/02/2001 VERSALAB APM NICOLET BIOMEDICAL DAVID W WAGNER
K013309 10/04/2001 GLUCOPRO EVO INFUSION PUMP NIPRO DIABETES SYSTEMS, INC. KAELYN B HADLEY
K013293 10/02/2001 NIPRO HYPODERMIC NEEDLE NIPRO MEDICAL CORP. KAELYN B HADLEY
K013287 10/02/2001 NIPRO SAFELET CATH NIPRO MEDICAL CORP. KAELYN B HADLEY
K013319 10/05/2001 NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR NONIN MEDICAL, INC. RICHARD P BENNETT
K013436 10/16/2001 NORMATEC PCD NORMATEC, INC. JONATHAN S KAHAN
K013353 10/09/2001 NEUROSPECTQUAD GAMMA CAMERA NUCLEAR CARDIOLOGY SYSTEMS, INC. CHARLES H ROSE
K013601 10/31/2001 NUMED MULLINS PTA CATHETER NUMED, INC. NICHELLE R LAFLESH
K013257 10/01/2001 HEMI-ARC SURGICAL NAVIGATOR NUVASIVE, INC. LAETITIA BERNARD
K013377 10/12/2001 BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC. RICHARD LIPPMAN
K013428 10/16/2001 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM OHIO MEDICAL INSTRUMENT CO., INC. DONALD A LINCOLN
K013591 10/30/2001 XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K013390 10/15/2001 QUICKCLOT ON SITE GAS SYSTEMS, INC. C. BURTON GULLONG
K013575 10/29/2001 KPS-I, THE KIDNEY PERFUSION SOLUTION ORGAN RECOVERY SYSTEMS, INC. STANLEY J HARRIS
K013339 10/09/2001 PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS OSCOR INC. MILA DOSKOCIL
K013429 10/16/2001 ACTAEON PROBE OSTEOBIOLOGICS, INC. MARK Q NIEDERAUER
K013371 10/11/2001 UBIT-IR300 INFRARED SPECTROMETRY SYSTEM OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K013362 10/10/2001 AUTOJECT 2 OWEN MUMFORD USA, INC. ROBERT SHAW
K013513 10/22/2001 DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE PAIN CONCEPTS, INC. RUSSELL PFLUEGER
K013310 10/04/2001 PVS BASIC 2; EPIC 2 PARAGON VISION SCIENCES WILLIAM E MEYERS
K013489 10/22/2001 KP + LFM PDS HEALTHCARE PRODUCTS, INC. JIM LEWIS
K013410 10/15/2001 AT HOME DRUG TEST, MODEL 9064 PHAMATECH INC. CARL MONGIOVI
K013412 10/15/2001 AT HOME DRUG TEST, MODEL 9069 PHAMATECH INC. CARL MONGIOVI
K013409 10/15/2001 AT HOME DRUG TEST, MODEL 9074 PHAMATECH INC. CARL MONGIOVI
K013408 10/15/2001 AT HOME DRUG TEST, MODEL 9079 PHAMATECH INC. CARL MONGIOVI
K013407 10/15/2001 AT HOME DRUG TEST, MODEL 9084 PHAMATECH INC. CARL MONGIOVI
K013425 10/16/2001 HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K013344 10/09/2001 INTERA I/T PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PETER ALTMAN
K013470 10/18/2001 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS, INC. MIKE HUDON
K013427 10/16/2001 MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A PHILIPS MEDICAL SYSTEMS, INC. DAVE OSBORN
K013451 10/18/2001 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K013340 10/09/2001 RT-PLUS KNEE ADDITIONAL COMPONENTS PLUS ORTHOPEDICS HARTMUT LOCH
K013547 10/24/2001 BABYCOM PMG MEDICA LTD. ELI M ORBACH
K013411 10/15/2001 PULPDENT CAVITY PREPARATION IV PULPDENT CORP. KENNETH J BERK
K013358 10/10/2001 DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. ROBERT DUFFY
K013478 10/19/2001 DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. ROBERT DUFFY
K013328 10/05/2001 REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 REMINGTON PRODUCTS COMPANY, L.L.C. PAMELA J FURMAN
K013367 10/10/2001 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH REYNOLDS MEDICAL LTD. GEORGE MYERS
K013482 10/19/2001 ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K013373 10/11/2001 OMNI C ANALYZER ROCHE DIAGNOSTICS CORP. JENNIFER TRIBETT
K013278 10/01/2001 TINA-QUANT APOLIPOPROTEIN A-1 VER.2 ROCHE DIAGNOSTICS CORP. HELEN TORNEY
K013583 10/30/2001 ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K013539 10/24/2001 ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS ROSSMAX INTERNATIONAL LTD. MICHAEL YEH
K013266 10/01/2001 RUSCH POLYFLEX STENT KIT RUSCH INTL. KARENANN J BROZOWSKI
K013379 10/12/2001 SAS STREPALERT SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K013439 10/17/2001 ANTERIOR CERVICAL PLATE SYSTEM SCIEN'TX USA INC. JOANNA DROEGE
K013440 10/17/2001 ISOBAR SPINAL SYSTEM SCIEN'TX USA INC. JOANNA DROEGE
K013444 10/17/2001 ISOBAR SPINAL SYSTEM SCIEN'TX USA INC. JOANNA DROEGE
K013447 10/17/2001 ISOBAR SPINAL SYSTEM SCIEN'TX USA INC. JOANNA DREOGE
K013555 10/25/2001 SCI-PHARM POST SECURE SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K013560 10/26/2001 SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT JAY MANSOUR
K013585 10/30/2001 MEDIPORT 2000 MOBILE SERVOX MEDIZINTECHNIK GMBH MARTIN HERBERG
K013276 10/01/2001 ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) SEWOON MEDICAL CO., LTD. DANIEL KAMM
K013288 10/02/2001 NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E SGMP CO., LTD. JANNA TUCKER
K013261 10/01/2001 MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE SHANGHAI MOTEX HEALTHCARE CO., LTD. TONY T K CHENG
K013327 10/05/2001 CTS-415 SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K013384 10/12/2001 SHARGHP A.V. FISTULA NEEDLE SET SHARGH PHARMACEUTICAL CO., INC. ARMAND HAMEDANI
K013523 10/23/2001 CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 SHIRE BIOLOGICS INC. ANGELA ROGERS
K013267 10/01/2001 POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS SIAM SEMPERMED CORP. LTD. KATIE LEVINSON
K013515 10/22/2001 INFINITY EXPLORER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K013586 10/30/2001 MAGNETOM TRIO SYSTEM SIEMENS MEDICAL SYSTEMS, INC. JAMIE YIEH
K013522 10/23/2001 SOMATOM P30 CT SYSTEMS SIEMENS MEDICAL SYSTEMS, INC. PRAVEEN NADKARNI
K013549 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K013544 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K013545 10/24/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K013426 10/16/2001 MOONRAY MOBILE C-ARM SIMAD S.R.L. JEFFREY S KEES
K013306 10/04/2001 MINIME NASAL MASK, MODEL P/N 50220 SLEEPNET CORPORATION PAUL R CHIESA
K013469 10/18/2001 EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD. KEVIN WALLS
K013467 10/18/2001 TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR SOFLEX CONTACT LENS INDUSTRIES LTD. KEVIN WALLS
K013488 10/19/2001 SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 SOPHYSA SA JACQUELINE E MASSE
K013394 10/15/2001 LIFTLOC SAFETY INFUSION SET SPECIALIZED HEALTH PRODUCTS, INC. MARK NELSON
K013312 10/04/2001 P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) SPINEVISION, INC. LYNNETTE WHITAKER
K013301 10/03/2001 UNI-T SPINAL SYSTEM SPINEVISION, INC. LYNNETTE WHITAKER
K013548 10/24/2001 STANDARD IMAGING IVB 1000 WELL CHAMBER STANDARD IMAGING, INC. RAYMOND RIDDLE
K013450 10/17/2001 NOTTA AMBULATORY RECORDER STELLATE SYSTEMS GEORGE PAPAGIANNIS
K013484 10/19/2001 TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH STEREOTAXIS, INC. PETER A TAKES
K013280 10/02/2001 STERILOX LIQUID CHEMICAL STERILANT SYSTEM STERILOX TECHNOLOGIES, INC. HOWARD MANN
K013502 10/22/2001 SIMPLICITY CLASSIC WING QD INFUSION SET STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K013316 10/04/2001 SICKLE-CHEX STRECK LABORATORIES, INC. PAUL KITTELSON
K013494 10/22/2001 3.75MM AND 5.0MM SPLINE TWIST IMPLANT SULZER DENTAL, INC. FOSTER BOOP
K013589 10/30/2001 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA SUPERMAX GLOVE MANUFACTURING SDN BHD STANLEY THAI
K013337 10/09/2001 PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI SURGIN INC DON HAAR
K013460 10/18/2001 SWIFT LOW PROFILE CUP (PRO CUP) SWIFT DELIVERY PRODUCTS RICHARD G LINDSAY
K013609 10/31/2001 NEXUS 2 CLEAR SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013510 10/22/2001 POINT 4 MODIFIED SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013529 10/23/2001 POINT 4 TRANSLUCENT MODIFIED SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013527 10/23/2001 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM SYNTHES (USA) BONNIE J SMITH
K013415 10/15/2001 SYNTHES ANKLE ARTHRODESIS PLATE SYNTHES (USA) MATTHEW M HULL
K013323 10/05/2001 TCI-31 LIFELONG OVULATION TESTER TCI NEW YORK ERIKA B AMMIRATI
K013321 10/05/2001 SILICONE TRACHEAL T-TUBES TECHNICAL PRODUCTS, INC. NORBERT D THOMPSON
K013300 10/03/2001 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM TECHNOLOGY DELIVERY SYSTEMS, INC. DAVID W SCHLERF
K013307 10/04/2001 OMEGATRAC, MODEL Z105 TEFTEC CORP. THOMAS E FINCH, III
K013317 10/04/2001 TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TEKMEDIC (M) SDN BHD KOK-KEE HON
K013526 10/23/2001 CAPIOX RX HARDSHELL RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K013578 10/29/2001 PUMP TUBING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K013550 10/24/2001 CLIRANS E-SERIES DIALYZER TERUMO MEDICAL CORP. SANDI HARTKA
K013279 10/02/2001 MOSFET AUTOSENSE, MODEL TN-RD-60 THOMSON & NIELSEN ELECTRONICS, LTD. NORMA THOMSON
K013286 10/02/2001 CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA TILLOTSON HEALTHCARE CORP. THOMAS N TILLOTSON
K013324 10/05/2001 HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT TILLOTSON HEALTHCARE CORP. F.W. PERRELLA
K013608 10/31/2001 DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIANA THORSON
K013363 10/10/2001 CROSSPOINT TRANSACCESS CATHETER TRANS VASCULAR INCORPORATED STEVE JWANOUSKOS
K013368 10/11/2001 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013580 10/29/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013556 10/25/2001 MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE TYCO HEALTHCARE DAVID A OLSON
K013372 10/11/2001 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST UNIPATH LTD. STEVEN H ARMSTRONG
K013594 10/30/2001 BODY ARRAY COIL USA INSTRUMENTS, INC. RONY THOMAS
K013528 10/23/2001 CRYSTAL 5000 PHASES ARRAY TMJ COIL USA INSTRUMENTS, INC. RONY THOMAS
K013592 10/30/2001 EXTREMITY COIL USA INSTRUMENTS, INC. RONY THOMAS
K013595 10/30/2001 PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. RONY THOMAS
K013541 10/24/2001 SHOULDER COIL USA INSTRUMENTS, INC. RONY THOMAS
K013486 10/19/2001 VAPOTHERM 2000H VAPOTHERM, INC. PAUL E DRYDEN
K013308 10/04/2001 VENTLAB HYPERINFLATION BAG SYSTEM VENTLAB CORP. MARGE WALLS-WALKER
K013477 10/19/2001 TOCO LITE, MODEL TD-01 VENTREX, INC. ROBERT GUTHRIE
K013282 10/02/2001 GORE INTRODUCER SHEATH W. L. GORE & ASSOCIATES, INC. R. LARRY PRATT
K013346 10/09/2001 GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W.L. GORE & ASSOCIATES,INC JACQUELINE KALBACH
K013557 10/24/2001 LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW WALTER LORENZ SURGICAL, INC. TRACY J BICKEL
K013356 10/10/2001 WILSON-COOK ULTRASOUND BIOPSY NEEDLE WILSON-COOK MEDICAL, INC. MARGARET J POSNER
K013473 10/18/2001 XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL XTRAK MEDICAL INC. DEBBIE IAMPIETRO
K013385 10/12/2001 NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE ZIMMER, INC. STEPHEN MCKELVEY


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