| 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 |
| 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 |
| K013442 |
10/17/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K013431 |
10/16/2001 |
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 |
| K013447 |
10/17/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DREOGE |
| K013444 |
10/17/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
| 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 |
