| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K041717 |
06/24/2004 |
POWERSTICK MALE LATEX CONDOMS |
A.P.DEAUVILLE, LLC. |
SCOTT L BAIER |
| K041687 |
06/22/2004 |
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR |
ABBOTT LABORATORIES |
KENT SMITH |
| K041550 |
06/09/2004 |
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
| K041759 |
06/29/2004 |
ACE CONNECT INTERNAL CONNECTION |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARDS CARCHIDI |
| K041685 |
06/22/2004 |
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG, PH.D. |
| K041743 |
06/28/2004 |
ACON TRI-FECT DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K041604 |
06/14/2004 |
MACRO-MICRO DEPTH ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
Gary Syring |
| K041577 |
06/14/2004 |
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
ADAC LABORATORIES |
RANDY VADER |
| K041614 |
06/15/2004 |
MICROLUX DL |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K041662 |
06/18/2004 |
APNEA RISK EVALUATION SYSTEM (ARES) |
ADVANCED BRAIN MONITORING, INC. |
DANIEL J LEVENDOWSKI |
| K041623 |
06/16/2004 |
REUSABLE STERILCONTAINER FILTER MODEL #JK090 |
AESCULAP, INC. |
MATTHEW M HULL |
| K041628 |
06/16/2004 |
AESKULISA DS DNA G |
AESKU.DIAGNOSTICS |
STANLEY AMMONS |
| K041753 |
06/29/2004 |
AESKULISA ENA 6 S |
AESKU.DIAGNOSTICS |
STANLEY AMMONS |
| K041554 |
06/10/2004 |
AIP INTENSE PULSED LIGHT SYSTEM |
AESTHERA CORPORATION |
C. ROBERT PAYNE |
| K041701 |
06/22/2004 |
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM |
AGFA CORP. |
JEFFERY A JEDLICKA |
| K041585 |
06/14/2004 |
AUTOFUSER AMBULATORY INFUSION PUMP |
ALGOS, LC |
ROBERT J BARD |
| K041734 |
06/25/2004 |
AMBU DISPOSABLE ECG ELECTRODE |
AMBU, INC. |
SANJAY PARIKH |
| K041712 |
06/23/2004 |
'RAPIDTEC 4' TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K041696 |
06/22/2004 |
RAPID READER |
AMERICAN BIO MEDICA CORP. |
FRAN WHITE |
| K041566 |
06/10/2004 |
SONOSURG ULTRASONIC SURGICAL SYSTEM |
AOMORI OLYMPUS CO., LTD. |
TINA STEFFANIE-OAK |
| K041766 |
06/30/2004 |
EZY-TRAVEL WRISTBAND |
APOTHECARY PRODUCTS, INC. |
DAVID KRAMER |
| K041711 |
06/23/2004 |
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
| K041506 |
06/07/2004 |
INTRAVASCULAR ACCESS INTRODUCER SHEATH |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
| K041745 |
06/28/2004 |
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K041686 |
06/22/2004 |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K041477 |
06/03/2004 |
PATHFINDER |
ARMSTRONG HEALTHCARE LIMITED |
PATRICK A FINLAY |
| K041740 |
06/28/2004 |
SILICONE COATED GUIDEWIRE |
ARROW INTERNATIONAL, INC. |
SUZANNE SCHORLE |
| K041589 |
06/11/2004 |
ARTHREX FIBERWIRE WITH SILK |
ARTHREX, INC. |
ANN WATERHOUSE |
| K041553 |
06/09/2004 |
ARTHREX SUTURE GRAFTING KIT |
ARTHREX, INC. |
ANN WATERHOUSE |
| K041531 |
06/08/2004 |
ASAHI PTCA GUIDE WIRE CONFIANZA PRO |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K041726 |
06/25/2004 |
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX |
ASAHI MEDICAL CO., LTD. |
DAVID L WEST |
| K041451 |
06/01/2004 |
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 |
ASCENSION ORTHOPEDICS, INC. |
PETER STRZEPA |
| K041670 |
06/21/2004 |
BIS PEDIATRIC SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
RENEE GOULD |
| K041492 |
06/04/2004 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K041681 |
06/21/2004 |
ATRICURE DISSECTOR |
ATRICURE, INC. |
MARK JOB |
| K041698 |
06/22/2004 |
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR |
AXYA MEDICAL, INC. |
Howard Schrayer |
| K041748 |
06/29/2004 |
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) |
AZOG, INC. |
AZUBUIKE OGALA |
| K041683 |
06/21/2004 |
B. BRAUN BICARBONATE DIALYSATE |
B. BRAUN MEDICAL, INC. |
JENNIFER A PUNG |
| K041490 |
06/04/2004 |
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING |
B. BRAUN MEDICAL, INC. |
JENNIFER A PUNG, |
| K041508 |
06/07/2004 |
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
| K041738 |
06/28/2004 |
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) |
BAXTER HEALTHCARE CORPORATION |
KAREN SPRANGER |
| K041643 |
06/17/2004 |
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K041478 |
06/03/2004 |
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR |
BECTON DICKINSON |
JOHN SCHALAGO |
| K041572 |
06/14/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML |
BECTON, DICKINSON AND CO. |
MONICA E GIGUERE |
| K041457 |
06/01/2004 |
LIQUICHEK HEMATOLOGY CONTROL (A) |
BIO-RAD |
ELIZABETH PLATT |
| K041561 |
06/10/2004 |
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL |
BIO-RAD |
MARIA ZEBALLOS |
| K041444 |
06/01/2004 |
BIO-RAD D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
JACKIE BUCKLEY |
| K041658 |
06/18/2004 |
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 |
BIO-RAD LABORATORIES, INC. |
CHRISTOPHER BENSTEN |
| K041619 |
06/15/2004 |
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 |
BIOCHECK, INC. |
ROBIN J HELLEN, M.S. |
| K041564 |
06/10/2004 |
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 |
BIOJECT MEDICAL TECHNOLOGIES INC. |
LAURENCE A POTTER |
| K041466 |
06/02/2004 |
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) |
BIOMET MANUFACTURING CORP. |
TRACY J BICKEL, RAC |
| K041595 |
06/14/2004 |
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 |
BIOPRO, INC. |
DAVID MARK |
| K041732 |
06/25/2004 |
CAVERMAP SURGICAL AID |
BLUE TORCH MEDICAL TECHNOLOGIES |
FREDERICK TOBIA |
| K041606 |
06/15/2004 |
EXTRACTOR RX RETRIEVAL BALLOON |
BOSTON SCIENTIFIC CORP. |
JAMES D MCMAHON |
| K041716 |
06/24/2004 |
PTFE FELTS AND PLEDGETS |
BOSTON SCIENTIFIC CORP. |
MAUREEN MONTBRIAND |
| K041727 |
06/25/2004 |
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
BOSTON SCIENTIFIC SCIMED, INC. |
ROBERT Z PHILLIPS |
| K041703 |
06/22/2004 |
IPLAN! |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K041714 |
06/23/2004 |
E-PAIN CARE |
BREG, INC. |
KATHLEEN BARBER |
| K041767 |
06/30/2004 |
COOLCUBE COOLPEN |
BRUCE J. SAND M.D. |
BRUCE J SAND, M.D. |
| K041464 |
06/02/2004 |
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K041659 |
06/18/2004 |
C-BOOT |
C-BOOT LTD. |
AVI ABRAHAM |
| K041652 |
06/17/2004 |
ACUPUNCTURE NEEDLES |
C.A.I. INDUSTRIES CORP. |
LU RAO |
| K041641 |
06/17/2004 |
DAVOL DELIVERY SYSTEM |
C.R. BARD, INC. |
SUZANNE LASCALZA |
| K041576 |
06/11/2004 |
SOURCELINK |
C.R. BARD, INC. |
JOHN C KNORPP |
| K041546 |
06/09/2004 |
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI |
CANON INC. |
SHEILA DRISCOLL |
| K041700 |
06/22/2004 |
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR |
CANTOR & NISSEL LTD. |
MARTIN DALSING |
| K041671 |
06/21/2004 |
IMAGENMD |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MALINIE HASEK |
| K041630 |
06/16/2004 |
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS |
CARDIOVASCULAR SYSTEMS INCORPORATED |
Gary Syring |
| K041486 |
06/04/2004 |
VASOSTASIS VASCULAR CLOSURE SYSTEM |
CARDIVA MEDICAL, INC. |
AUGUSTINE LIEN |
| K041645 |
06/17/2004 |
DDS-ZR |
CHARLES SCHARF |
CHRIS SCHARF |
| K041518 |
06/07/2004 |
CODMAN DURAFORM DURAL GRAFT IMPLANT |
Codman & Shurtleff, Inc. |
ELIZABETH DOLAN |
| K041655 |
06/18/2004 |
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) |
COWELL MEDI CO LTD. |
DAE KYU CHANG |
| K041569 |
06/10/2004 |
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 |
CURELIGHT LTD |
JONATHAN S KAHN |
| K041689 |
06/22/2004 |
POLYURETHANE BLOOD PRESSURE CUFFS |
D. E. HOKANSON, INC. |
D. EUGENE HOKANSON |
| K041503 |
06/07/2004 |
HOVERJACK AIR PATIENT LIFT DEVICE |
D.T. DAVIS ENTERPRISES LTD. |
DAVID T DAVIS |
| K041438 |
06/01/2004 |
ADVANCED D-DIMER ASSAY |
DADE BEHRING, INC. |
KATHLEEN DRAYLYONS |
| K041627 |
06/16/2004 |
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR |
DAKO A/S |
DANA OLSEN |
| K041524 |
06/08/2004 |
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K041680 |
06/21/2004 |
ORAJEL ADVANCED TOOTH DESENSITIZER |
DEL PHARMACEUTICALS, INC. |
MARLENE TIETJEN |
| K041458 |
06/01/2004 |
MARE DENTAL OPERATIVE UNIT |
DENIMED ELECTRONICA S.H. |
GEORGE ECHEVERRI |
| K041707 |
06/23/2004 |
CERCON CERAM EXPRESS CERAMIC SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K041656 |
06/18/2004 |
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI ROGERS |
| K041722 |
06/24/2004 |
MODIFICATION TO VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
| K041666 |
06/18/2004 |
DC-ACETA/SAL CONTROLS |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K041582 |
06/14/2004 |
MODIFICATION TO TRIPTER X-1 COMPACT DUET |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K041622 |
06/16/2004 |
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
| K041739 |
06/28/2004 |
EDWARDS E360 SURGICAL ABLATION DEVICE |
EDWARDS LIFESCIENCES, LLC. |
ELIZABETH MORAN |
| K041629 |
06/16/2004 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K041522 |
06/07/2004 |
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
| K041644 |
06/17/2004 |
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
| K041647 |
06/17/2004 |
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
| K041598 |
06/14/2004 |
LASEREX, MODEL LP4532 |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K041708 |
06/23/2004 |
ENPATH SAFETY INTRODUCER |
ENPATH MEDICAL INCORPORATED |
KARYL HASKELL |
| K041638 |
06/17/2004 |
TARGETSCAN BIOPSY KIT |
ENVISIONEERING, LLC. |
TOM KAPPEL |
| K041637 |
06/17/2004 |
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM |
ENVISIONEERING, LLC. |
TOM KAPPEL |
| K041639 |
06/17/2004 |
TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM |
ENVISIONEERING, LLC. |
TOM KAPPEL |
| K041442 |
06/01/2004 |
EP-4 CLINICAL STIMUTATOR |
EP MEDSYSTEMS |
JAMES E KUHN JR. |
| K041599 |
06/14/2004 |
COBRA ADHERE SURGICAL SYSTEM |
ESTECH, INC. |
CRAIG COOMBS |
| K041575 |
06/14/2004 |
FENZIAN TREATMENT SYSTEM |
EUMEDIC LIMITED |
LEWIS W WARD |
| K041757 |
06/29/2004 |
FEMSPEC DISPOSABLE VAGINAL SPECULUM |
FEMSPEC L.L.C. |
GERALD JAY SANDERS |
| K041470 |
06/02/2004 |
MORTON IUI CATHETERS |
FERTILITY TECHNOLOGY RESOURCES, INC. |
CONSTANCE W STURGEON |
| K041596 |
06/14/2004 |
ARCHITECT STAT CK-MB IMMUNOASSAY |
FISHER DIAGNOSTICS |
JOSEFINA INFANTAS |
| K041456 |
06/01/2004 |
SNAP-OFF SCREWS |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K041509 |
06/07/2004 |
ANKYLOS DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
| K041471 |
06/02/2004 |
G-BOND |
GC AMERICA INC. |
TERRY L JORITZ |
| K041543 |
06/08/2004 |
GE DISCOVERY ST |
GE HEALTHCARE |
LARRY A KROGER |
| K041476 |
06/03/2004 |
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER PH.D. |
| K041552 |
06/09/2004 |
GE VIVID 7 BT04 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K041688 |
06/22/2004 |
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K041521 |
06/08/2004 |
VOLUME VIEWER PLUS |
GENERAL ELECTRIC MEDICAL SYSTEMS |
LARRY KRUEGER |
| K041605 |
06/15/2004 |
PRECISION RXI ANALOG X-RAY SYSTEM |
GENERAL MEDICAL MERATE S.P.A. |
Kevin Walls |
| K041563 |
06/10/2004 |
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS |
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. |
ANTHONY G AMITRANO |
| K041718 |
06/24/2004 |
KELES FACEMASK |
GREAT LAKES ORTHODONTICS, LTD. |
DAVE GRAVER |
| K041501 |
06/07/2004 |
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS |
GUANGZHOU FORTUNIQUE LTD. |
JANE B CAMPBELL |
| K041574 |
06/14/2004 |
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 |
GUIDANT CORPORATION |
AMITA SHENAI |
| K041762 |
06/30/2004 |
FINISHING WIRE SUPPORTRAK |
GUIDANT CORPORATION |
JENNIFER TANG |
| K041633 |
06/16/2004 |
GYRUS PLASMACISION LAPAROSCOPIC SPATULA |
GYRUS MEDICAL, INC. |
DAVID E CHADWICK |
| K041636 |
06/17/2004 |
H&S-CONDUCTIVITY STANDARD SOLUTION |
H & S TECHNICAL SERVICES |
JOHN HYTE |
| K041504 |
06/07/2004 |
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 |
HAEMACURE CORP. |
ELAINE WHITMORE |
| K041502 |
06/07/2004 |
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY |
HAEMOSCOPE CORP. |
ELI COHEN |
| K041694 |
06/22/2004 |
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
| K041692 |
06/22/2004 |
INFRARED EAR THERMOMETER, ET-100 SERIES |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
| K041693 |
06/22/2004 |
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
| K041690 |
06/22/2004 |
MONARCH NASAL IMPLANT |
HANSON MEDICAL, INC. |
GERALD HANSON |
| K041580 |
06/14/2004 |
IMAGERAYI |
HENRY SCHEIN, INC. |
W. EDWARD JOHANSEN |
| K041555 |
06/10/2004 |
SECURVIEW DX SOFTCOPY WORKSTATION |
HOLOGIC, INC. |
RICHARD FOLLETT |
| K041591 |
06/14/2004 |
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K041706 |
06/23/2004 |
HOFFMANN II FOOT RING |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K041709 |
06/23/2004 |
NUMELOCK II SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K041710 |
06/23/2004 |
VERSAWAVE DENTAL ER:YAG LASER SYSTEM |
HOYA CONBIO |
JIM GREEN |
| K041721 |
06/24/2004 |
LVI AESTHETIC LASER |
HOYA PHOTONICS, INC. |
JIM GREEN |
| K041702 |
06/22/2004 |
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) |
IBT SA |
RUTH FEICHT |
| K041517 |
06/07/2004 |
INFUSIONCATH, MODELS VI0020, VI20024, VI0028, VI0032, VI0036, VI0040, VI0044 |
ID LLC |
MARIO ARBESU |
| K041728 |
06/25/2004 |
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE |
IMMUNOSTICS, INC. |
JEFFREY FLEISHMAN |
| K041590 |
06/14/2004 |
AUTODETECT SYRINGE |
INDIGO ORB, INC. |
ROBERT CHIN |
| K041761 |
06/30/2004 |
RAPIDIACOLON |
INFINITT CO., LTD. |
CARL ALLETTO |
| K041500 |
06/07/2004 |
STARPACS ORTHOPEDICS SYSTEM |
INFINITT CO., LTD. |
CARL ALLETTO |
| K041583 |
06/11/2004 |
PEEK CEMENT RESTRICTOR X-BOX |
INNOVASIS, INC. |
BRENT A FELIX |
| K041650 |
06/17/2004 |
MICRO PRIME |
INNOVX MEDICAL, INC. |
ELAINE DUNCAN |
| K041620 |
06/16/2004 |
NEURA WRAP NERVE PROTECTOR |
INTEGRA LIFESCIENCES CORP. |
DIANA M BORDON |
| K041581 |
06/14/2004 |
COMPACS, VERSION 1.0 |
INTELLIGENT IMAGES SRL |
MAURIZIO PAIGGIO |
| K041449 |
06/01/2004 |
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
| K041562 |
06/10/2004 |
CRYOTIP |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K041755 |
06/29/2004 |
CROMAX HIGH SPEED TURBINE HANDPIECE |
J.R. MEDICAL TECHNOLOGIES, INC. |
J. HARVEY KNAUSS |
| K041678 |
06/21/2004 |
KARMA POWER WHEELCHAIR, MODEL KP-25 |
KARMA MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K041677 |
06/21/2004 |
KARMA SCOOTER, MODEL KS-747.2 |
KARMA MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K041642 |
06/17/2004 |
V.A.C. GRANUFOAM SILVER DRESSING |
KINETIC CONCEPTS, INC. |
JUDITH HARBOUR |
| K041461 |
06/02/2004 |
KMI DISTAL VOLAR RADIUS PLATE SYSTEM |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
| K041584 |
06/14/2004 |
KYPHX HV-R BONE CEMENT, MODEL C01A |
KYPHON, INC. |
CINDY DOMECUS |
| K041454 |
06/01/2004 |
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A |
KYPHON, INC. |
CINDY DOMESCUS |
| K041624 |
06/16/2004 |
PTCA STEERABLE HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K041565 |
06/10/2004 |
LAZRPULSR 4X |
LED HEALING LIGHT LLC |
MICHAEL B KINDER |
| K041446 |
06/01/2004 |
NASALCEASE |
LES LABORATORIRES BROTHIER, S.A. |
RICHARD J FREER, PH.D. |
| K041747 |
06/29/2004 |
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) |
LIFEPOINT,INC |
DAVID B GOLDBERG |
| K041746 |
06/29/2004 |
IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) |
LIFEPOINT,INC |
DAVID B GOLDBERG, PH.D. |
| K041535 |
06/08/2004 |
LSC LIFESTAND COMPACT |
LIFESTAND |
CAROLANN KOTULA |
| K041713 |
06/23/2004 |
SUPER REVO HERCULINE SUTURE ANCHOR |
LINVATEC CORP. |
ELIZABETH M PAUL |
| K041520 |
06/07/2004 |
MANTRA TENS MODEL NT3 |
MANTRA INTL. (HK) LTD. |
ROBERT B SPERTELL |
| K041485 |
06/04/2004 |
MARPAC MESSENGER MODEL #501 |
MARPAC, INC. |
EVELYN TRUJILLO |
| K041724 |
06/24/2004 |
COMPASS M10 SYSTEM |
MEDCARE FLAGA |
BERGLIND HALLGRIMSDOTTIR |
| K041579 |
06/14/2004 |
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 |
MEDELA AG |
WERNER FREI |
| K041600 |
06/14/2004 |
QWIKCHECK-BEADS |
MEDICAL ELECTRONICS SYSTEMS LTD. |
Erika B Ammirati |
| K041448 |
06/01/2004 |
HEXAPOD RT COUCHTOP |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
SANDOR CSABA ATS |
| K041621 |
06/16/2004 |
LITEPORT LP100 SURGICAL ILLUMINATOR |
MEDICAL VISION INDUSTRIES, INC. |
DAVID SCHLERF |
| K041527 |
06/08/2004 |
AARHUS ANCHORAGE SYSTEM |
MEDICON, E.G. |
COLLEEN BOSWELL |
| K041459 |
06/02/2004 |
LIFEPAK 12 DEFIBRILLATOR/MONITOR |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
MICHELLE ACKERMANN |
| K041452 |
06/01/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K041556 |
06/10/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K041460 |
06/02/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K041523 |
06/08/2004 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
| K041626 |
06/16/2004 |
IMMUNOCARD STAT! FLU A & B |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K041445 |
06/01/2004 |
IMMUNOCARD STAT! RSV MODEL #750630 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K041649 |
06/17/2004 |
SAPPHIRE NXT DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| DEN040008 |
06/17/2004 |
CEDIA SIROLIMUS ASSAY |
MICROGENICS CORP. |
DAVID CASAL |
| K041551 |
06/09/2004 |
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K041632 |
06/16/2004 |
MINIMESH POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K041481 |
06/03/2004 |
MODEL BBC-127 BIOPSY BREAST COIL |
MRI DEVICES CORP. |
THOMAS E TYNES |
| K041573 |
06/14/2004 |
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
| K041542 |
06/08/2004 |
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS |
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. |
WANG ZHIQIANG |
| K041704 |
06/23/2004 |
NEWGEL AND NEWGEL PLUS E |
NEWMEDICAL TECHNOLOGY, INC. |
HAITHAM MATLOUB |
| K041751 |
06/29/2004 |
COMPRESSION ANASTOMOSIS CLIP (CAC) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
| K041661 |
06/18/2004 |
NOBEL BIOCARE ENDOSSEOUS IMPLANTS |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K041560 |
06/10/2004 |
FLO-ASSISTANT |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K041613 |
06/15/2004 |
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
| K041715 |
06/23/2004 |
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 |
NUCLETRON CORP. |
LISA DIMMICK |
| K041719 |
06/24/2004 |
ONCENTRA-VISIR |
NUCLETRON CORP. |
LISA DIMMICK |
| K041447 |
06/01/2004 |
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA BERNARD |
| K041668 |
06/18/2004 |
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT |
OLYMPUS AMERICA INC. |
BEV HARDING |
| K041494 |
06/04/2004 |
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 |
OLYMPUS CORPORATION |
TINA STEFFANIE-OAK |
| K041705 |
06/23/2004 |
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K041664 |
06/18/2004 |
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C |
ON SITE GAS SYSTEMS, INC. |
C. BART GULLONG |
| K041679 |
06/21/2004 |
COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT |
ONYX MEDICAL INC. |
ROGER MACHSON |
| K041440 |
06/01/2004 |
OPUS MAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
| K041764 |
06/30/2004 |
THE VITROS 5,1 FS CHEMISTRY SYSTEM |
ORTHO-CLINICAL DIAGNOSTICS |
CAREY A MAYO |
| K041720 |
06/24/2004 |
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K041616 |
06/15/2004 |
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID |
ORTHOS (UK) LIMITED |
ALAN RORKE |
| K041443 |
06/01/2004 |
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K041665 |
06/18/2004 |
L1-PRO SYSTEM |
PELIKAN TECHNOLOGIES, INC |
JACK S GREEN |
| K041495 |
06/04/2004 |
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS |
PENTAFERTE S.P.A |
VITTORIO SERVIDORI |
| K041496 |
06/04/2004 |
PENTATRASFU BLOOD TRANSFUSION SETS |
PENTAFERTE S.P.A |
VICTOR PEREIRA |
| K041736 |
06/28/2004 |
PFA PATCH |
PERITEC BIOSCIENCES, LLC. |
ROBERT M DICKSON |
| K041578 |
06/14/2004 |
QUICKSCREEN, MODELS 9177X AND 9178X |
PHAMATECH |
CARL MONGIOVI |
| K041674 |
06/21/2004 |
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT |
PHILIPS MEDICAL SYSTEMS |
J.P. OUELLETTE |
| K041602 |
06/14/2004 |
PANORAMA 1.0T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
JOSEPH S ARNAUDO |
| K041741 |
06/28/2004 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN |
PHILIPS MEDICAL SYSTEMS, INC. |
BARRY WYSHOGROD |
| K041675 |
06/21/2004 |
PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS |
PIE MEDICAL |
CARRI GRAHAM |
| K041682 |
06/21/2004 |
CAAS MRV |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
| K041750 |
06/29/2004 |
PTS PANELS CHOL+GLU TEST PANEL |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K041635 |
06/16/2004 |
G5 I HBA1C TEST, G5 II HBA1C TEST |
PROVALIS DIAGNOSTICS LTD. |
THOMAS M TSAKERIS |
| K041607 |
06/15/2004 |
QUINTON Q-TE; RMS |
QUINTON CARDIOLOGY, INC. |
KAREN BROWNE |
| K041450 |
06/01/2004 |
MODIFICATION TO NICO WITH MARS, MODEL 7300 |
RESPIRONICS NOVAMETRIX, INC. |
KEVIN MADER |
| K041568 |
06/10/2004 |
EOCD |
RESPIRONICS, INC. |
LOU ANNE KINNEY |
| K041610 |
06/15/2004 |
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K041441 |
06/01/2004 |
SAS INFLUENZA A TEST |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K041439 |
06/01/2004 |
SAS INFLUENZA B TEST |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
| K041646 |
06/17/2004 |
THERMOTEK Q5 |
SAAT LTD. |
E.J. Smith |
| K041667 |
06/18/2004 |
SAN-MAR LABS LUBRICATING JELLY |
SAN-MAR LABORATORIES, INC. |
SIMON SANDERS |
| K041749 |
06/29/2004 |
SCANDIUS ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
ERIC BANNON |
| K041548 |
06/09/2004 |
SENTEC DIGITAL MONITOR MODEL #SDM |
SENTEC INC. |
STEPHEN GORSKI |
| K041763 |
06/30/2004 |
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES |
SHIMADZU CORP. |
TAKESHI OZAKI |
| K041484 |
06/04/2004 |
UNDECIDED |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
RICHARD K ANDERSEN |
| K041482 |
06/11/2004 |
DECAPINOL ORAL RINSE |
SINCLAIR PHARMACEUTICALS LIMITED |
MICHAEL KILLEEN |
| K041465 |
06/02/2004 |
SINON SN-L402 LIGHTWEIGHT WHEELCHAIR |
SINON CORPORATION |
JEN KE-MIN |
| K041453 |
06/01/2004 |
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
| K041455 |
06/01/2004 |
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
SONOSCAPE COMPANY LIMITED |
BOB LEIKER |
| K041559 |
06/10/2004 |
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 |
SPIRE BIOMEDICAL INC |
DONALD FICKETT |
| K041540 |
06/08/2004 |
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K041653 |
06/17/2004 |
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K041541 |
06/08/2004 |
COMPEL MLR SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K041539 |
06/08/2004 |
COMPEL SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K041530 |
06/08/2004 |
EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 |
STARGATE INTERNATIONAL, INC. |
ROBERT H WALKER |
| K041558 |
06/10/2004 |
STOCKERTIR PURGE CONTROL (APC) SYSTEM |
STOCKERT INSTRUMENTE GMBH |
ROSINA ROBINSON |
| K041754 |
06/29/2004 |
STRYKER MAESTRO SYSTEM |
STRYKER CORP. |
NICOLE PETTY |
| K041651 |
06/17/2004 |
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
| K041601 |
06/14/2004 |
SURFIX KNEE OSTEOTOMY SYSTEM |
SURFIX TECHNOLOGIES |
NORMAN F ESTRIN |
| K041593 |
06/14/2004 |
FEATHERLIFT EXTENDED LENGTH APTOS THREAD |
SURGICAL SPECIALTIES CORP. |
RICHARD JONES |
| K041617 |
06/15/2004 |
STALIF TT |
SURGICRAFT LTD. |
JANET M WEBB |
| K041512 |
06/07/2004 |
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K041514 |
06/07/2004 |
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K041515 |
06/07/2004 |
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K041511 |
06/07/2004 |
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K041510 |
06/07/2004 |
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K041474 |
06/02/2004 |
MAXCEM |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K041669 |
06/21/2004 |
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD |
SYNOVIS SURGICAL INNOVATIONS |
JAMES JENKINS |
| K041611 |
06/15/2004 |
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP |
SYNTHES (USA) |
LISA M BOYLE |
| K041533 |
06/08/2004 |
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS |
SYNTHES (USA) |
Lisa Boyle |
| K041648 |
06/17/2004 |
NITI-S STENT & INTRODUCER, MODEL EOXXXX |
TAEWOONG MEDICAL CO., LTD |
JAMES HARVY KNAUSS |
| K041752 |
06/29/2004 |
TEH LIN POWERED WHEELCHAIR, MDG-601 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
JEN KE-MIN |
| K041493 |
06/04/2004 |
CEMENTEK |
TEKNIMED SA |
J.D. WEBB |
| K041697 |
06/22/2004 |
TERUMO CIRCUIT CONNECTORS |
Terumo Cardiovascular Systems Corporation |
GARRY A COURTNEY |
| K041592 |
06/14/2004 |
CORAL SPINAL SYSTEM |
THEKEN SURGICAL |
RANDY THEKEN |
| K041657 |
06/18/2004 |
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT |
THERMO ELECTRON CORPORATION |
BOLA NICHOLSON |
| K041557 |
06/10/2004 |
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MARY HERBERT |
| K041499 |
06/07/2004 |
SSA-770A, APLIO VERSION 5.5 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K041737 |
06/28/2004 |
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K041534 |
06/08/2004 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
| K041660 |
06/18/2004 |
TRIMEDYNE HOLMIUM LASER SYSTEMS |
TRIMEDYNE, INC. |
GLENN YEIK |
| K041771 |
06/30/2004 |
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM |
TWIN STAR MEDICAL, INC. |
JONATHAN KAHAN |
| K041625 |
06/15/2004 |
LTD POLYAXIAL FIXATION SYSTEM |
U.S. SPINAL TECHNOLOGIES, LLC. |
ELAINE DUNCAN |
| K041608 |
06/15/2004 |
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS |
UNILENS CORP., USA |
JOSEPHA BRUNO |
| K041545 |
06/09/2004 |
CONTACT DETACH |
UNOMEDICAL A/S |
JOHN M LINDSKOG |
| K041544 |
06/09/2004 |
COOK SIDEARM CORE TISSUE BIOPSY DEVICE |
UROLOGICAL INC. |
CINDY RUMPLE |
| K041695 |
06/22/2004 |
LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE |
USA INSTRUMENTS, INC. |
JAMES WRENN |
| K041487 |
06/04/2004 |
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT |
USA INSTRUMENTS, INC. |
JAMES WRENN |
| K041587 |
06/14/2004 |
LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 |
VALLEYLAB |
CHARLES COPPERBERG |
| K041519 |
06/07/2004 |
MODIFICATION TO: ON-BOARD IMAGER DEVICE |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K041528 |
06/08/2004 |
MODIFICATION TO EPTFE GRAFT |
VASCUTEK LTD. |
STEVEN ARICK |
| K041516 |
06/04/2004 |
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K041473 |
06/02/2004 |
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K041468 |
06/02/2004 |
PREMICATH, 1261.205 |
VYGON CORP. |
COURTNEY SMITH |
| K041691 |
06/22/2004 |
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT |
WEST PHARMACEUTICAL SERVICES, INC. |
DAVID WEISER |
| K041663 |
06/18/2004 |
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRIAN J YOUNG |
| K041586 |
06/14/2004 |
PROFEMUR S HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE H REDDEN |
| K041469 |
06/02/2004 |
ANTERIOR COMPACT SYSTEM |
X-SPINE SYSTEMS |
JANET M WEBB |
| K041491 |
06/04/2004 |
ZEWA MFM-007 BLOOD PRESSURE MONITOR |
ZEWA, INC. |
THOMAS ZEINDLER |
| K041525 |
06/08/2004 |
HEMOVAC BLOOD REINFUSION SYSTEM |
ZIMMER, INC. |
CINDY J DICKEY |
| K041549 |
06/09/2004 |
ZIMMER TRABECULAR METAL HUMERAL STEM |
ZIMMER, INC. |
DALENE BINKLEY |
