| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K051790 |
07/25/2005 |
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 |
3M COMPANY |
GINGER CANTOR |
| K051797 |
07/21/2005 |
FUTURE WASH/YPS |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
| K050862 |
07/25/2005 |
3TP WORKSPACE |
3TP LLC |
MICHAEL KOCHIAN |
| K051108 |
07/08/2005 |
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K051215 |
07/21/2005 |
CELL-DYN SAPPHIRE SYSTEM |
ABBOTT LABORATORIES |
MICHELLE ROEDING |
| K051381 |
07/15/2005 |
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K051410 |
07/21/2005 |
ACUMED RIB CONGRIENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
| K042562 |
07/29/2005 |
LENS PLUS REWETTING DROPS |
ADVANCED MEDICAL OPTICS, INC. |
PETER XU |
| K043353 |
07/01/2005 |
OMEGA EXCEL/XP LASER SYSTEM |
ADVANCED MEDICAL TECHNOLOGIES, INC. |
M. JOYCE HEINRICH |
| K050979 |
07/27/2005 |
S4 SPINAL SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
| K051216 |
07/19/2005 |
HYDRALOK SYSTEM |
ALTIVA CORP. |
JOHN KAPITAN |
| K051621 |
07/11/2005 |
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
DONALD V CANAL |
| K041696 |
07/12/2005 |
RAPID READER |
AMERICAN BIO MEDICA CORP. |
FRAN WHITE |
| K051530 |
07/08/2005 |
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. |
AMERICAN MEDICAL SYSTEMS, INC. |
DENISE THOMPSON |
| K050785 |
07/15/2005 |
AMSINO ENDOTRACHEAL TUBE |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K051142 |
07/13/2005 |
ANGIODYNAMICS TUMESCENT INFUSION DEVICE |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K042791 |
07/01/2005 |
INSTANT-X, MODELS 1713 & 128 |
ANN ARBOR DIGITAL DEVICES |
WILLIAM J O'NEILL |
| K051795 |
07/14/2005 |
NOMAD DENTAL X-RAY SYSTEM |
ARIBEX, INC. |
D.CLARK TURNER |
| K051652 |
07/22/2005 |
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY BROWN |
| K051011 |
07/12/2005 |
ENDOSSEOUS DENTAL IMPLANT ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K050687 |
07/28/2005 |
AXIOM EPS8000 |
AXIOM WORLDWIDE, INC. |
JAMES J GIBSON |
| K050574 |
07/22/2005 |
AFINION HBALC |
AXIS-SHIELD POC AS |
RONALD G LEONARDI |
| K033028 |
07/22/2005 |
ANEFIN, MODEL 100 |
AXON MEDICAL |
JOSEPH ORR |
| K050832 |
07/07/2005 |
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT |
BARD PERIPHERAL VASCULAR, INC. |
DENNIS SALZMANN |
| K051253 |
07/15/2005 |
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K051194 |
07/25/2005 |
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 |
BECTON DICKINSON & CO. |
LESLIE WOOD |
| K042472 |
07/07/2005 |
BD DIRECTIGEN EZ FLU A + B |
BECTON, DICKINSON & CO. |
GREG PAYNE |
| K051692 |
07/14/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K051272 |
07/11/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K051266 |
07/05/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K051695 |
07/19/2005 |
MARROW PLUS (M+) |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K050135 |
07/13/2005 |
K-C HEMOSTATIC BIOPSY SYSTEM |
BIOENGINEERING CONSULTANTS LTD. |
WILLIAM R KRAUSE |
| K043428 |
07/12/2005 |
RELIADENT DENTAL IMPLANT SYSTEM |
BIOINFERA, INC. |
CHAN Q WANG |
| K050210 |
07/19/2005 |
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES |
BIOMET, INC. |
LONNIE WITHAM |
| K051845 |
07/27/2005 |
THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
| K051679 |
07/14/2005 |
ILAB ULTRASOUND IMAGING SYSTEM |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
| K051316 |
07/18/2005 |
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER |
C.R. BARD, INC. |
JOHN C KNORPP |
| K051359 |
07/13/2005 |
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
| K050940 |
07/01/2005 |
PMP4 MEDICAL WEB CENTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K050808 |
07/28/2005 |
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 |
CARDIO-OPTICS, INC. |
LARRY BLANKENSHIP |
| K051681 |
07/27/2005 |
DERMILLUME RED, MODEL HR1000 |
CARE ELECTRONICS, INC. |
THOMAS O MOODY |
| K050951 |
07/19/2005 |
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 |
CIBERNET SYSTEMS CORP. |
ERIC LICHTENSTEIN |
| K033579 |
07/11/2005 |
REPROCESSED MULTIPLE CLIP APPLIERS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
| K033578 |
07/11/2005 |
REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
| K050739 |
07/18/2005 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
Codman & Shurtleff, Inc. |
KAREN F JURCZAK |
| K050992 |
07/14/2005 |
CONMED IRRIGATION NOZZLE |
CONMED CORP. |
IRA DUESLER |
| K041849 |
07/21/2005 |
TURBO-FLO PICC |
COOK, INC. |
EARL E KNIGHT III |
| K051124 |
07/12/2005 |
ZILVER 635 BILIARY STENT |
COOK, INC. |
STEPHANIE ROBERTS |
| K050635 |
07/28/2005 |
ALLFIM IMPLANT SYSTEMS |
COWELL MEDI CO LTD. |
DAE KYU CHANG |
| K050379 |
07/12/2005 |
CS MEDICAL ADULT TTCF CATHETER |
CS MEDICAL INC. |
LEWIS WARD |
| K050381 |
07/13/2005 |
CS MEDICAL TTCF GAS DELIVERY SYSTEM |
CS MEDICAL INC. |
LEWIS WARD |
| K051443 |
07/22/2005 |
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO |
CURASAN AG, FRANKFURT FACILITY |
ERIC WIECHERT |
| K050793 |
07/07/2005 |
LANDLEX MODEL S400X |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
CHANG WAN-LAN |
| K050507 |
07/07/2005 |
SMARTECH, MODEL HOLI I |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
CHANG WAN-LAN |
| K051087 |
07/11/2005 |
DIMENSION VISTA INTEGRATED SYSTEM |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K051478 |
07/27/2005 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K051311 |
07/12/2005 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K051350 |
07/25/2005 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
ROBERTO EUSEBIO |
| K050620 |
07/14/2005 |
READMYHEART, MODEL RMH3.0 |
DAILYCARE BIOMEDICAL INC |
DANIEL J CHANG |
| K051707 |
07/15/2005 |
ECLIPSE BONDING AGENT |
DENTSPLY INTL. |
HELEN LEWIS |
| K051463 |
07/12/2005 |
XENO ADHESIVE WITH ACTIVATOR |
DENTSPLY INTL. |
HELEN LEWIS |
| K050991 |
07/15/2005 |
THE ODFS DROPPED FOOT STIMULATOR |
DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. |
TINA LECHMAN |
| K051024 |
07/06/2005 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K043406 |
07/15/2005 |
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT |
DEPUY SPINE,INC |
SHARON STAROWICZ |
| K051191 |
07/05/2005 |
DCL MICROALBUMIN ASSAY, MODEL 252-20 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
| K051549 |
07/13/2005 |
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K051776 |
07/13/2005 |
PROTEGE ULTRASONIC INSERT |
DISCUS DENTAL INC. |
SUZANNE RIDGWAY |
| K051571 |
07/19/2005 |
SKYLIGHT LED CURING LIGHT |
DMETEC CO., LTD. |
CAROLANN KOTULA |
| K042522 |
07/06/2005 |
JAUNDICE METER, MODEL JM 103 |
DRAEGER MEDICAL INFANT CARE, INC. |
THOMAS M MCINTOSH |
| K051628 |
07/20/2005 |
INFINITY MONITORS WITH SCIO MODIFICATIONS |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K051263 |
07/12/2005 |
EVITAXL WITH OPTION SMARTCARE |
DRAGER MEDICAL AG & CO. KGAA |
MONICA FERRANTE |
| K051261 |
07/25/2005 |
DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE |
DYNATRONICS CORP. |
RONALD J HATCH |
| K051724 |
07/19/2005 |
ACUMEN IMAGE GUIDED SURGICAL SYSTEM |
EBI, L.P. |
WHITNEY TORNING |
| K051746 |
07/25/2005 |
ELEKTA ESARTE FRAME SYSTEM |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K043238 |
07/06/2005 |
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES |
EMG TECHNOLOGY CO., LTD. |
LEONARD FRIER |
| K051509 |
07/27/2005 |
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K051837 |
07/20/2005 |
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K043055 |
07/25/2005 |
TERRAQUANT MQ2000 LASER THERAPY DEVICE |
ESCADA INTERNATIONAL, INC. |
MARY MCNAMARA-CULLINANE |
| K051764 |
07/13/2005 |
T-PLATE ANTERIOR FIXATION SYSTEM |
ESM TECHNOLOGIES |
CLIFF TRIBUS |
| K043032 |
07/19/2005 |
DEALIGHT IPL |
EUROPRO, INC. |
GREG KENNEBECK |
| K040283 |
07/22/2005 |
BIOPAD |
EURORESEARCH S.R.L. |
E. SMITH |
| K051550 |
07/12/2005 |
INSPIRATION VENTILATOR SYSTEM |
EVENT MEDICAL LTD. |
ROBBIE WALSH |
| K051393 |
07/27/2005 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR |
EVER GLOBAL ENTERPRISE CORPORATION |
NICK BIEN |
| K051498 |
07/06/2005 |
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR |
EVER GLOBAL ENTERPRISE CORPORATION |
NICK BIEN |
| K051682 |
07/19/2005 |
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM |
EXACTECH, INC. |
MARITZA ELIAS |
| K051446 |
07/14/2005 |
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS |
FIRST QUALITY HYGIENIC INC. |
ROBERT J STAAB |
| K051062 |
07/15/2005 |
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO |
FLOWCARDIA, INC. |
RICHARD SPANO |
| K051553 |
07/07/2005 |
FUJI SYNAPSE WORKSTATION SOFTWARE |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
ROBERT BERRY |
| K051358 |
07/07/2005 |
NATURE-CRYL HI PLUS |
GC AMERICA, INC. |
TERRY L JORITZ |
| K051634 |
07/19/2005 |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION |
GE HEALTHCARE |
JOEL C KENT |
| K051635 |
07/15/2005 |
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K051673 |
07/18/2005 |
XELERIS 2 PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K051026 |
07/19/2005 |
MARS HOLTER ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
| K051518 |
07/08/2005 |
UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RONALD N BLASKI |
| K051490 |
07/07/2005 |
GE OEC EVERVIEW 7500 |
GE OEC MEDICAL SYSTEMS, INC. |
SUSAN SCHMIDT |
| K043035 |
07/11/2005 |
SEPRAGEL ENT BIORESORBABLE PACKING/STENT |
GENZYME CORPORATION |
BARBARA PIZZA |
| K051686 |
07/14/2005 |
CARDIOMEM CM 3000-12 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CAROLANN KOTULA |
| K050391 |
07/21/2005 |
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K051668 |
07/08/2005 |
THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT |
GOODMARK USA, INC. |
ROBERT J MICHALIK |
| K051662 |
07/22/2005 |
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
MICKY LIN |
| K051429 |
07/29/2005 |
CLARIS NON-STICK BIPOLAR FORCEPS |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
CHRISTA HEITMANN-FRANKE |
| K043322 |
07/21/2005 |
MIRAMATIC SAFE SYRINGE SYSTEM |
HAGER WORLDWIDE, INC. |
JAMES DELANEY |
| K051728 |
07/20/2005 |
MODIFICATION TO SHOULDER FIXATION SYSTEM |
HAND INNOVATIONS, LLC. |
ERNESTO HERNANDEZ |
| K051610 |
07/29/2005 |
HANS HERMANN LAPAROSCOPES AND ACCESSORIES |
HANS HERMANN GMBH |
HARALD JUNG |
| K051224 |
07/28/2005 |
BOSWORTH SEAL |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K051778 |
07/26/2005 |
NITRILE POWDERED EXAMINATION GLOVES (BLUE) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K050053 |
07/11/2005 |
HEMORAM/AGGRAM ANALYZER |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K050854 |
07/07/2005 |
PALACOS LV+G |
HERAEUS KULZER GMBH |
CHRISTIAN TUCHSCHERER |
| K050855 |
07/07/2005 |
PALAMED G |
HERAEUS KULZER GMBH |
CHRISTIAN TUCHSCHERER |
| K051147 |
07/12/2005 |
SIDEKICK BLOOD GLUCOSE TEST SYSTEM |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K051588 |
07/12/2005 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051737 |
07/19/2005 |
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051738 |
07/19/2005 |
SECUR-FIT MAX AND PLUS MAX HIP STEMS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051624 |
07/07/2005 |
T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K051146 |
07/13/2005 |
TRIATHLON KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K051590 |
07/29/2005 |
T2 ANKLE ARTHRODESIS NAIL |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K050410 |
07/14/2005 |
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) |
HWANG SUN ENTERPRISE CO., LTD. |
SING-HONG YEUNG |
| K051430 |
07/18/2005 |
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) |
HYDROGEL VISION CORPORATION |
DONNA HOVANEC |
| K051412 |
07/11/2005 |
HUMERAL HEAD PLATE WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K051110 |
07/06/2005 |
1,25-DIHYDROXY VITAMIN D EIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
PAUL PUNTIN |
| K050395 |
07/13/2005 |
IMPEDIMED - BODY COMPOSITION ANALYSIS |
IMPEDIMED PTY LTD. |
NEVELLI BERTWISTLE |
| K051717 |
07/07/2005 |
RN SYNOCTA TEMPORARY MESO ABUTMENT |
INSTITUT STRAUMANN SA |
LINDA JALBERT |
| K041893 |
07/29/2005 |
INTRALASE FS LASER |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K050690 |
07/07/2005 |
CONNEXUS |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
| K043573 |
07/29/2005 |
DYNAGRAFT II DENTAL |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
| K051780 |
07/28/2005 |
JETLITE 5000 |
J. MORITA USA, INC. |
HOWARD ROWE |
| K051365 |
07/22/2005 |
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 |
K-JUMP HEALTH CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K051454 |
07/27/2005 |
ALEUTIAN SPACER SYSTEM |
K2M, LLC |
RICH WOODS |
| K051545 |
07/18/2005 |
L.E. DEMETRON II |
KERR CORPORATION (DANBURY) |
COLLEEN BOSWELL |
| K051418 |
07/01/2005 |
DIRECT DIGITIZER REGIUS MODEL 370 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI MAMANAKA |
| K051523 |
07/20/2005 |
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K051538 |
07/21/2005 |
AVANTICARE, MODEL SA4022 |
LERADO CHINA LIMITED |
JEFF CHANG |
| K050018 |
07/01/2005 |
TESLAOXYSAT, MODEL EFOXYSATE |
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH |
ROBERT N CLARK |
| K050542 |
07/26/2005 |
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER |
MARIAN MEDICAL, INC. |
SANDRA WINKLER |
| K051439 |
07/15/2005 |
LNOP BLUE OXIMETRY SENSOR |
MASIMO CORPORATION |
JAMES J CRONIN |
| K051212 |
07/12/2005 |
MODIFICATION TO LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K051375 |
07/28/2005 |
VITAL SIGNS MONITOR |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K051488 |
07/27/2005 |
MEDICINELODGE ZIPKNOT |
MEDICINELODGE, INC. |
M. MRY SINNOTT |
| K051745 |
07/14/2005 |
ECHOSYSTEM |
MEDSTRAT, INC. |
ROBERT J BISHOP |
| K051773 |
07/28/2005 |
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
PAULA CORDERO |
| K050651 |
07/27/2005 |
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION |
MEDTRONIC NAVIGATION, INC. |
TINA DREILING |
| K051674 |
07/21/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K050436 |
07/27/2005 |
MS 9/5 HEMATOLOGY ANALYZER |
MELET SCHLOESING LABORATORIES USA |
JACKIE COLEMAN |
| K051323 |
07/07/2005 |
MERETE TWISTCUT SNAP-OFF BONE SCREW |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K051528 |
07/20/2005 |
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE |
MEVIS TECHNOLOGY GMBH & CO. KG |
CARL ALLETTO |
| K051423 |
07/01/2005 |
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MIOK |
| K050570 |
07/25/2005 |
MILTEX RIGID STERILIZATION CONTAINER SYSTEM |
MILTEX, INC. |
LEE ZAGAR |
| K043528 |
07/19/2005 |
SPIROTEL |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K051625 |
07/14/2005 |
BARRIER SURGICAL DRAPES |
MOLNLYCKE HEALTH CARE, INC. |
JOHN CLAY |
| K051739 |
07/28/2005 |
POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. |
MULTIGON INDUSTRIES, INC. |
WILLIAM STERN |
| K042125 |
07/28/2005 |
AFT |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
KAREN HARDWICK |
| K050224 |
07/13/2005 |
3TEST GLUCOSE MONITORING SYSTEM |
NEUERO ENGINEERING INC. |
Ke-Min Jen |
| K051765 |
07/14/2005 |
CERETOM, MODEL NL3000 |
NEUROLOGICA CORPORATION |
BRAHIM HADRI |
| K051599 |
07/19/2005 |
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT |
NEURORECOVERY, INC. |
ROSINA ROBINSON |
| K050444 |
07/07/2005 |
NOBELREPLACE ADAPTER, MODEL 32412 |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K051256 |
07/21/2005 |
SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
WILLIAM F MCNALLY |
| K042875 |
07/01/2005 |
NAVIGATOR |
NOMOS CORP. |
LEIGH SPOTTEN |
| K051486 |
07/06/2005 |
NORWOOD ABBEY CENTURION SES EPIKERATOME |
NORWOOD ABBEY , LTD. |
PAUL CLARK |
| K051009 |
07/12/2005 |
HUBER CLEAR SAFETY INFUSION SET |
NOW MEDICAL DISTRIBUTION, INC. |
CHRISTINE EMANNUEL |
| K050857 |
07/28/2005 |
BIB PTA BALLOON CATHETER |
NUMED, INC. |
JODI GIJANTO |
| K051343 |
07/28/2005 |
MINI GHOST PTA CATHETER, MODEL 507 |
NUMED, INC. |
NICHELLE LAFLESH |
| K051384 |
07/11/2005 |
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K051541 |
07/01/2005 |
GF-UE160-AL5 ULTRASOUND ENDOSCOPE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K050502 |
07/08/2005 |
SINGLE USE BALLOON DILATOR MAXPASSTM |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
| K041008 |
07/01/2005 |
EYE-CEPT REWETTING DROPS |
OPTICS LABORATORY, INC. |
J.R. CHEN |
| K051255 |
07/01/2005 |
LUMIPHASE-R |
OPUSMED INC. |
IAN GORDON |
| K050260 |
07/15/2005 |
BIORESORB MACRO PORE |
ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH |
CHAD BARTEE |
| K050966 |
07/07/2005 |
PIVOT BIPOLAR FEMORAL HEAD |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K051751 |
07/22/2005 |
EQUA-PULL SAFETY RELEASE MODULE |
ORTHO TECHNOLOGY |
STEVE KLAMIC |
| K051162 |
07/19/2005 |
GENEROS SB SMALL BONE DISTRACTION IMPLANT |
ORTHONETX, INC. |
TERRY KNAPP |
| K051053 |
07/21/2005 |
OSCAR, MODEL OE3000DB |
ORTHOSONICS, LTD. |
T. WHIT ATHEY |
| K051664 |
07/20/2005 |
SCAN300FP / RETROPAN (VDC) |
OY AJAT, LTD. |
CLAUDE D BERTHOIN |
| K051465 |
07/12/2005 |
POWDERED LATEX PATIENT EXAMINATION GLOVES |
P.T. ANLIS ABADI INTERNASIONAL |
HUAN-CHUNG LI |
| K051106 |
07/01/2005 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
| K051372 |
07/07/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR) |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
| K050968 |
07/12/2005 |
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K051767 |
07/29/2005 |
LTV 1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K050449 |
07/07/2005 |
QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
JASON BLAIN |
| K042725 |
07/06/2005 |
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) |
QUEST DIAGNOSTICS, INC. |
JAMES A BOURLAND |
| K042726 |
07/28/2005 |
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP |
QUEST DIAGNOSTICS, INC. |
JAMES A BOURLAND |
| K051339 |
07/12/2005 |
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
| K051743 |
07/25/2005 |
R2 BREAST IMAGING WORKSTATION |
R2 TECHNOLOGY, INC. |
DENISE F GOTTFRIED |
| K051268 |
07/06/2005 |
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT |
RADIANCY, LTD. |
JONATHAN S KAHAN |
| K051309 |
07/11/2005 |
ROI FUSION RODS & PLATES |
REILEY ORTHOPAEDICS, INC. |
J.D. WEBB |
| K050841 |
07/05/2005 |
FRAXEL SR LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K051314 |
07/15/2005 |
RES TRAXX DATA CENTER |
RESMED LTD. |
DAVID D'CRUZ |
| K051262 |
07/08/2005 |
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 |
RESPIRONICS CALIFORNIA, INC. |
MARY FUNK |
| K051752 |
07/11/2005 |
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) |
Roche Diagnostics |
THERESA M AMBROSE |
| K051185 |
07/06/2005 |
ELECSYS CA 19-9 CALCHECK |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K050231 |
07/06/2005 |
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K051517 |
07/05/2005 |
ELECSYS PRECICONTROL ANEMIA |
ROCHE DIAGNOSTICS CORP. |
CORNIA HARPER |
| K051687 |
07/25/2005 |
ELECSYS PRECICONTROL UNIVERSAL |
ROCHE DIAGNOSTICS CORP. |
CORINA HARPER |
| K051012 |
07/19/2005 |
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. |
SALIMETRICS LLC. |
VIRGINIA MCKAY MCKAY |
| K051581 |
07/27/2005 |
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K051019 |
07/25/2005 |
SAFETY NEEDLE |
SARSTEDT, INC. |
PETER RUMSWINKEL |
| K051150 |
07/26/2005 |
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K051141 |
07/26/2005 |
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K051942 |
07/27/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
| K051663 |
07/12/2005 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
| K051457 |
07/25/2005 |
SENTINEL PLASMAPROTEINS CAL 3X |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K050797 |
07/13/2005 |
TISSU-TRANS |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH LAKE |
| K051333 |
07/22/2005 |
NITRILE EXAMINATION GLOVES, POWDER FREE |
SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. |
ANAN JETSADAWISUT |
| K051329 |
07/19/2005 |
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS) |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K051602 |
07/07/2005 |
AXIOM SIRESKOP SD |
SIEMENS MEDICAL SYSTEMS, INC. |
GARY JOHNSON |
| K051659 |
07/13/2005 |
SEMIAL SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
| K051784 |
07/20/2005 |
OSTEOVATION CMF BONE VOID FILLER |
SKELETAL KINETICS, LLC |
DURAN YETKINLER |
| K051735 |
07/19/2005 |
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K051310 |
07/26/2005 |
PLC SCREW |
SMITH & NEPHEW, INC. |
BILL MCCALLUM |
| K051229 |
07/20/2005 |
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K051136 |
07/01/2005 |
SMITH & NEPHEW CDS SYSTEM |
SMITH & NEPHEW, INC. |
DIANE E MINEAR |
| K051524 |
07/07/2005 |
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
| K051155 |
07/11/2005 |
SOLCO 4CIS GENERAL PLATE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K050592 |
07/12/2005 |
SOMNOMED MAS RXA |
SOMNOMED LTD |
ELAINE DUNCAN |
| K041653 |
07/01/2005 |
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K051631 |
07/27/2005 |
EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 |
STARGATE INTERNATIONAL, INC. |
ROBERT H WALKER |
| K042648 |
07/20/2005 |
REPROCESSED COLD BIOPSY FORCEPS |
STERILMED, INC. |
BRUCE LESTER |
| K050136 |
07/20/2005 |
REPROCESSED HOT BIOPSY FORCEPS |
STERILMED, INC. |
BRUCE R LESTER |
| K051506 |
07/27/2005 |
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY |
STERYLAB S.R.L. |
PAUL E DRYDEN |
| K041342 |
07/19/2005 |
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION |
STIEFEL LABORATORIES, INC. |
MARY JANE CARR |
| K050461 |
07/27/2005 |
XIA 4.5 SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K051921 |
07/27/2005 |
THE EDGE DETECTOR, MODEL 1118 |
SUN NUCLEAR CORP. |
NOEL M DOWNEY |
| K051474 |
07/01/2005 |
SYMBIOS DISPOSABLE INFUSION PUMP KIT |
SYMBIOS MEDICAL PRODUCTS, LLC |
JEFFERY J ALHOLM |
| K051720 |
07/25/2005 |
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE |
SYNTHES (USA) |
KATHY ANDERSON |
| K051600 |
07/27/2005 |
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM |
SYNTHES (USA) |
KATHY ANDERSON |
| K051049 |
07/13/2005 |
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR |
SYNTHES (USA) |
KATHY ANDERSON |
| K050463 |
07/27/2005 |
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K050891 |
07/25/2005 |
TOX A/B QUICK CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K050823 |
07/26/2005 |
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K042579 |
07/28/2005 |
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE |
JAY H GELLER |
| K050342 |
07/11/2005 |
THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM |
THERALASE INC. |
ROGER WHITE |
| K051710 |
07/19/2005 |
THERMAGE THERMACOOL COUPLING FLUID |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K051527 |
07/28/2005 |
SPI EASY TEMPORARY CAP |
THOMMEN MEDICAL, AG |
FLOYD G LARSON |
| K050848 |
07/14/2005 |
TORNIER ELBOW PROSTHESIS |
TORNIER |
Mireille Lemery |
| K051763 |
07/14/2005 |
QD KNEE/FOOT COIL, MODEL MJQJ-147A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K051833 |
07/15/2005 |
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINGS |
| K051403 |
07/14/2005 |
19-INCH (48CM) COLOR LCD MONITOR CDL1904A |
TOTOKU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K051547 |
07/14/2005 |
POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 |
TPC ADVANCED TECHNOLOGY, INC. |
SCOTT BECKLEY |
| K050681 |
07/27/2005 |
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES |
TRIMED, INC. |
KELLI ANDERSON |
| K042583 |
07/19/2005 |
CALC-I-OSS |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
| K051184 |
07/01/2005 |
55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
UNITED CONTACT LENS, INC. |
GAROLD L EDWARDS |
| K050653 |
07/01/2005 |
TRANSEAR BONE CONDUCTION HEARING AID |
UNITED HEARING SYSTEMS, INC. |
RALPH CAMPAGNA |
| K051919 |
07/26/2005 |
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE |
USGI MEDICAL |
MARY LOU MOONEY |
| K051627 |
07/22/2005 |
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT |
VALLEYLAB |
HERBERT VINSON |
| K051180 |
07/22/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K051497 |
07/18/2005 |
VITESSE 2.0 |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K051287 |
07/29/2005 |
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K051559 |
07/08/2005 |
IMASK, MODELS 100, 200 AND 300 |
VITAL SIGNS COLORADO, INC. |
TOM DIELMANN |
| K051867 |
07/27/2005 |
GRANDIO |
VOCO GMBH |
GERALD W SHIPPS |
| K051868 |
07/27/2005 |
GRANDIO FLOW |
VOCO GMBH |
GERALD W SHIPPS |
| K050960 |
07/11/2005 |
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
| K051249 |
07/22/2005 |
ZIROX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K050887 |
07/11/2005 |
GONGDONG DISPOSABLE VAGINAL SPECULUM |
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
WEIFENG ZHONG |
| K050417 |
07/19/2005 |
ELITE IMPLANT |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K051424 |
07/15/2005 |
HYDROGUM 5 |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K051723 |
07/15/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) |
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K051623 |
07/19/2005 |
ANATOMICAL SHOULDER KEELED GLENOID |
ZIMMER GMBH |
BRANDON HIPSHER |
| K051756 |
07/27/2005 |
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K051098 |
07/07/2005 |
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K051516 |
07/27/2005 |
TRABECULAR METAL REVISION SHELL LINERS |
ZIMMER, INC. |
TONY KINGSLEY |
| K051068 |
07/11/2005 |
ZUTRON COLONOSCOPE STIFFENING DEVICE |
ZUTRON MEDICAL |
JORDAN HARTONG |
