| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K050279 |
04/11/2005 |
AXS-1 LITE WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K050280 |
04/11/2005 |
RUNABOUT WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K050281 |
04/11/2005 |
TRANSPORT SERIES TRANSPORT CHAIR |
ACCESS POINT MEDICAL, L.L.C. |
NORMAN F ESTRIN |
| K050950 |
04/29/2005 |
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS |
ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS |
EFRAIM BIDAS |
| K041614 |
04/04/2005 |
MICROLUX DL |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K050648 |
04/05/2005 |
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK |
ADVANCED MEDICAL OPTICS, INC. |
PAM SCHAUB |
| K050633 |
04/21/2005 |
TRIAL CABLE RETENTION CLIP |
ADVANCED NEUROMODULATION SYSTEMS |
RASHMI MOZA |
| K032959 |
04/04/2005 |
CIDEX OPA CONCENTRATE |
ADVANCED STERILIZATION PRODUCTS |
NEELU MEDHEKAR |
| K042116 |
04/22/2005 |
STERRAD NX STERILIZER |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K050752 |
04/27/2005 |
AESCULAP ORTHOPILOT 2 THA V 2.0 |
AESCULAP, INC. |
MATTHEW M HULL |
| K050804 |
04/11/2005 |
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K041554 |
04/27/2005 |
AIP INTENSE PULSED LIGHT SYSTEM |
AESTHERA CORPORATION |
C. ROBERT PAYNE |
| K050810 |
04/21/2005 |
AGFA CR50.0 |
AGFA CORP. |
JEFFERY A JEDLICKA |
| K050751 |
04/21/2005 |
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X |
AGFA CORP. |
PHIL CUSCUNA |
| K050553 |
04/18/2005 |
NOVEL VBR SPINAL SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
| K050699 |
04/15/2005 |
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 |
AMEDICA CORP. |
ROBERT M WOLFARTH |
| K043543 |
04/08/2005 |
BLOOD GLUCOSE MONITORING SYSTEM |
AMERICAN HEALTHCARE INC. |
EDWARD LETKO |
| K043512 |
04/08/2005 |
EASYGLUCO IGM-0002 G2 |
AMERICAN HEALTHCARE INC. |
EDWARD LETKO |
| K050256 |
04/26/2005 |
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR |
APPLE MEDICAL CORP. |
JAMES DELANEY |
| K043519 |
04/25/2005 |
ARIOL HER-2/NEU FISH |
APPLIED IMAGING CORP. |
DIANE C DAY |
| K050652 |
04/06/2005 |
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K050358 |
04/15/2005 |
ARTHERX CORKSCREW FT II SUTURE ANCHOR |
ARTHREX, INC. |
ANN WATERHOUSE |
| K042411 |
04/07/2005 |
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY |
AXIS-SHIELD LTD. |
SUSAN LEONARD |
| K050194 |
04/26/2005 |
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K050310 |
04/18/2005 |
BARDPORT TITANIUM PORTS |
BARD ACCESS SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K050157 |
04/26/2005 |
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
LISA GRANEY |
| K043228 |
04/22/2005 |
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS |
BAYER HEALTHCARE, LLC |
CAROL BIANCA |
| K050207 |
04/07/2005 |
BD POSIFLOW POSITIVE DISPLACEMENT VALVE |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K050555 |
04/14/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050747 |
04/29/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050745 |
04/29/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050666 |
04/11/2005 |
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K050712 |
04/22/2005 |
4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
| K050408 |
04/07/2005 |
BICON ORTHODONTIC IMPLANT SYSTEM |
BICON, INC. |
VINCENT J MORGAN |
| K050537 |
04/27/2005 |
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS |
BIO-RAD |
SUZANNE S PARSONS |
| K050682 |
04/29/2005 |
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) |
BIO-RAD LABORATORIES, INC. |
ELIZABETH PLATT |
| K050487 |
04/26/2005 |
QUANTIA LA(A) |
BIOKIT S.A. |
JOAN GUIXER |
| K050513 |
04/01/2005 |
MDA B.30 |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
| K042989 |
04/28/2005 |
RX90 LOW PROFILE ACETABULAR SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K050701 |
04/01/2005 |
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K050647 |
04/20/2005 |
ALL-IN-ONE |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K050700 |
04/15/2005 |
MATRIX STRETCH RESISTANT (SR) COILS |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
| K042721 |
04/19/2005 |
KOLIBRI SPINE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K050724 |
04/18/2005 |
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM |
C.R. BARD, INC. |
LORRAINE R PATA |
| K050688 |
04/06/2005 |
TEGRESS IMPLANT NEEDLE |
C.R. BARD, INC. |
TERRI MORRIS |
| K050153 |
04/15/2005 |
SPIRIT, MODEL HAS |
CAIRE, INC. |
DAN CHLAN |
| K050357 |
04/21/2005 |
CAMCERAM TCP |
CAM IMPLANTS B.V. |
KIM GROENEWEGAN VAN DER WEIJDEN |
| K050225 |
04/07/2005 |
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K050987 |
04/27/2005 |
DIGITAL RADIOGRAPHY MODEL CXDI-40EG |
CANON, INC. |
SHEILA DRISCOLL |
| K050115 |
04/01/2005 |
BLOOD HAND PUMP ADMINISTRATION SET |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K050324 |
04/27/2005 |
INFPUMP INFILTRATION PUMP |
CAROLINA MEDICAL, INC. |
LEON WILSON |
| K051013 |
04/27/2005 |
SPINEMED S200B/S200C |
CERT HEALTH SCIENCES, LLC |
TIM R EMSKY |
| K050611 |
04/06/2005 |
ENDOTINE RIBBON |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K050046 |
04/13/2005 |
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S |
COMPEX TECHNOLOGIES, INC. |
BRIAN J EDWARDS |
| K050777 |
04/22/2005 |
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 |
CONMED CORP. |
MICHAEL A PATZ |
| K050578 |
04/22/2005 |
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE |
COOK IRELAND LTD |
EMMETT DEVEREUX |
| K050645 |
04/01/2005 |
CORDIS AMIIA .014 PTA BALLOON CATHETER |
CORDIS CORP. |
KAREN WILK |
| K043538 |
04/18/2005 |
HYPERTRANSIT INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
| K050177 |
04/27/2005 |
COLACTIVE COLLAGEN WOUND DRESSING |
COVALON TECHNOLOGIES, INC. |
PAUL L GUILBAUD |
| K050792 |
04/21/2005 |
LANDLEX, MODEL S300X |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER |
CHANG WAN LAN |
| K050165 |
04/19/2005 |
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 |
CYDEN LIMITED |
MICHAEL NOEL KIERNAN |
| K050695 |
04/19/2005 |
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT |
DAAVLIN DISTRIBUTING CO. |
DAVID W SWANSON |
| K050676 |
04/12/2005 |
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K043539 |
04/06/2005 |
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES |
DEMETECH CORP. |
ARTHUR WARD |
| K042965 |
04/15/2005 |
TOMAS PIN |
DENTAURUM, INC. |
THOMAS LIETZ |
| K050880 |
04/22/2005 |
DYRACT EXTRA RESTORATIVE |
DENTSPLY INTL. |
HELEN LEWIS |
| K050750 |
04/06/2005 |
LC BRACKET ADHESIVE SYSTEM |
DENTSPLY INTL. |
HELEN LEWIS |
| K050771 |
04/08/2005 |
LUPINE LOOP |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
| K050675 |
04/11/2005 |
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE |
DEPUY SPINE, INC. |
LISA GILMAN |
| K040120 |
04/29/2005 |
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS |
DIASORIN, INC. |
DAVID M IKEDA |
| K043328 |
04/15/2005 |
MICROFLO-SAFE SCALP VEIN SET |
DKS LOVERSAN INDUSTRIA BIOMEDICA SPA |
ARTHUR WARD |
| K050974 |
04/29/2005 |
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K041826 |
04/27/2005 |
EKOS ULTRASOUND INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K042710 |
04/07/2005 |
SURGITRON RADIOLASE II |
ELLMAN INT'L INC. |
FRANK LIN |
| K042917 |
04/22/2005 |
STAT MEDICAL PEN NEEDLE |
EMERGO GROUP, INC. |
RENE VAN DE ZANDE |
| K050188 |
04/27/2005 |
EPIGUARD |
EPISAFE MEDICAL DEVICES, LTD. |
GEORGE J HATTUB |
| K043245 |
04/29/2005 |
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
JENNIFER REICH |
| K050725 |
04/20/2005 |
PROTEGE GPS SELF-EXPANDING NITINOL STENT |
EV3 CORPORATION |
GLEN D SMYTHE |
| K043527 |
04/05/2005 |
RELIEVA SINUS BALLOON DILATION CATHETER |
EXPLORAMED NC1, INC. |
WILLIAM M FACTEAU |
| K050134 |
04/05/2005 |
ICC INSULIN SAFEPRO SAFETY SYRINGE |
FORMOSA MEDICAL DEVICES, INC. |
C. Y. LIN |
| K050837 |
04/27/2005 |
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE |
GE HEALTHCARE |
JOEL KENT |
| K050614 |
04/05/2005 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
| K050704 |
04/08/2005 |
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING |
GENERAL ELECTRIC CO. |
JOHN L SCHMIDT |
| K043385 |
04/12/2005 |
OSOM HCG COMBO TEST |
GENZYME DIAGNOSTICS |
E.V. GOORCHENKO |
| K050664 |
04/07/2005 |
SPOR-TEST PA BIOLOGICAL INDICATOR KIT |
GETINGE USA, INC |
BARD SMITH |
| K050576 |
04/21/2005 |
MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
| K042927 |
04/15/2005 |
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
Judi Smith |
| K050755 |
04/06/2005 |
MODIFICATION TO BVBLUE |
GRYPHUS DIAGNOSTICS, LLC |
THOMAS M TSAKERIS |
| K043443 |
04/08/2005 |
ONE STEP HCG URINE PREGNANCY TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
HOWARD MANN |
| K042495 |
04/14/2005 |
CUMULASE |
HALOZYME THERAPEUTICS INC. |
DON KENNARD |
| K050768 |
04/28/2005 |
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 |
HAMILTON THORNE BIOSCIENCES |
DIARMAID H DOUGLAS-HAMILTON |
| K050932 |
04/26/2005 |
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM |
HAND INNOVATIONS, INC. |
ERNIE HERNANDEZ |
| K050508 |
04/27/2005 |
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES |
HAYWOOD VOCATIONAL OPPORTUNITIES |
TIM KELLEY |
| K050711 |
04/07/2005 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050714 |
04/07/2005 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050587 |
04/05/2005 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050169 |
04/05/2005 |
HL 200 ELECTRONIC STETHOSCOPE |
HEALTH & LIFE CO., LTD. |
JENNIFER REICH |
| K050567 |
04/05/2005 |
HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
GEOFFREY CLAPP |
| K050602 |
04/07/2005 |
ALTAIRE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K050483 |
04/12/2005 |
EVADRI BLADDER CONTROL SYSTEMS |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K050719 |
04/26/2005 |
ABX PENTRA DX 120: OPTION SPS EVOLUTION |
HORIBA ABX |
TIM LAWTON |
| K050274 |
04/29/2005 |
DIODENT II DENTAL LASER SYSTEM |
HOYA PHOTONICS, INC. |
JIM GREEN |
| K050083 |
04/08/2005 |
BLOOD-PRESSURE METER, BPW120 |
IDT TECHNOLOGY LIMITED |
LEON LEONG |
| K050772 |
04/21/2005 |
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K050505 |
04/05/2005 |
DEPOTONE |
IMPRINT PHARMACEUTICALS LIMITED |
MERVYN LITTLE |
| K042944 |
04/15/2005 |
HOME-AWAY SYSTEM, MODEL 1041 |
IN-X CORPORATION |
DOUGLAS POWELL |
| K043500 |
04/15/2005 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE |
INNOSPINE, INC. |
LARAINE PANGELINA |
| K050588 |
04/21/2005 |
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM |
INNOVATIVE SPINAL DESIGN, LLC |
LEIGH COWDEN |
| K050544 |
04/26/2005 |
HEMOSIL D-DIMER HS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K050496 |
04/29/2005 |
REM440 |
INTERACOUSTICS A/S, ASSENS |
DANIEL EGGAN |
| K050404 |
04/21/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K050369 |
04/29/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K050562 |
04/14/2005 |
OCULIGHT GL/GLX |
IRIDEX CORP. |
JOHN JOSSY |
| K050716 |
04/21/2005 |
ISCIENCE SURGICAL VISCOINJECTOR |
ISCIENCE SURGICAL CORPORATION |
JUDY F GORDON |
| K043531 |
04/21/2005 |
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
K-JUMP HEALTH CO., LTD. |
DANIEL TSENG |
| K043324 |
04/04/2005 |
AIDA WITH DICOM AND HL7 INTERFACE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K050744 |
04/21/2005 |
KAVO ERGOCOM/ERGOCAM |
KAVO AMERICA CORPORATION |
KANIEL KAMM |
| K050601 |
04/15/2005 |
SMARTDOP 45 VASCULAR DOPPLER |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K050774 |
04/11/2005 |
LANX ANTERIOR CERVICAL PLATE SYSTEM |
LANX, LLC |
DAVID W SCHLERF |
| K050708 |
04/26/2005 |
LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 |
LERADO OVERSEA LTD. TWN BRANCH (BVI) |
JEN KE-MIN |
| K050707 |
04/18/2005 |
LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 |
LERADO OVERSEA LTD. TWN BRANCH (BVI) |
JEN KE-MIN |
| K050506 |
04/15/2005 |
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS |
LIFECORE BIOMEDICAL, INC. |
RACHEL KENNEDY |
| K050193 |
04/11/2005 |
GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR |
LOUIS M. GERSON CO., INC. |
ROBERT BRUNELL |
| K050131 |
04/05/2005 |
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE |
M.K. MEDITECH CO. LTD. |
ROSINA ROBINSON |
| K050254 |
04/15/2005 |
SPECTRA-SP CO2 LASER SYSTEM |
MAX ENGINEERING LTD. |
MAUREEN O'CONNEL |
| K050770 |
04/14/2005 |
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT |
MCKINLEY MEDICAL LLC |
RALPH D COOEY |
| K041579 |
04/21/2005 |
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 |
MEDELA AG |
WERNER FREI |
| K043614 |
04/14/2005 |
VACULINK, MODEL VCL 3000 |
MEDEVCO, INC. |
KRISTA OAKES |
| K043419 |
04/15/2005 |
P&P SAFETY SYRINGE |
MEDEXEL MEDICAL MFG. CO., LTD. |
DANIEL KAMM |
| K042526 |
04/25/2005 |
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX |
MEDICAL ACTION INDUSTRIES, INC. |
ROBIN BLANKENBAKER |
| K050376 |
04/07/2005 |
PROWIN |
MEDICAL TECHNOLOGIES INTERNATIONAL, INC. |
MARC BOZENAN |
| K050490 |
04/11/2005 |
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER |
MEDICREA |
J.D. WEBB |
| K050181 |
04/13/2005 |
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
MEDIGLOVES LTD. |
KATHE BRENNER DEANE |
| K050703 |
04/21/2005 |
QBRAIN |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K050038 |
04/13/2005 |
RELIANT STENT GRAFT BALLOON CATHETER |
MEDTRONIC ENDOVASCULAR INNOVATIONS |
WILLIE MITCHELL |
| K043053 |
04/11/2005 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050560 |
04/21/2005 |
EUROCHAIR |
MEYRA, INC. |
KIRK L MACKENZIE |
| K050543 |
04/27/2005 |
NEXUS DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
| K050340 |
04/27/2005 |
MICROMEDICS SPHENOID SINUS STENT |
MICROMEDICS, INC. |
THOMAS A LOPAC |
| K050740 |
04/06/2005 |
MICROWARE 200 |
MICROWARE INC |
MICHAEL B MCGRAW |
| K043231 |
04/25/2005 |
PROOF POSITIVE ELECTRONIC PREGNANCY TEST |
MIZUHO USA, INC. |
BENEDICT ZIN |
| K043380 |
04/26/2005 |
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 |
MONEBO TECHNOLOGIES, INC. |
DALE J MISCZYNSKI |
| K050622 |
04/08/2005 |
HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL |
MRI DEVICES CORPORATION |
THOMAS SCHUBERT |
| K050621 |
04/07/2005 |
NVA-127-8-A NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORPORATION |
THOMAS SCHUBERT |
| K040501 |
04/29/2005 |
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
KAREN HARDWICK |
| K050765 |
04/08/2005 |
LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE |
N.S. UNI-GLOVES SDN. BHD. |
KENNETH J STANTON |
| K043156 |
04/28/2005 |
D-CARIE, MODEL N121-M1 |
NEKS TECHNOLOGIES, INC. |
CHARLES H KYPER |
| K050377 |
04/07/2005 |
NBD HEAD SCREW |
NEW BUSINESS DEVELOPMENT, LLC |
TIM B LUSBY |
| K050833 |
04/29/2005 |
ELECTRODE JUNCTION BOX, MODEL JE-921A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K050258 |
04/19/2005 |
GROOVY IMPLANTS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K050641 |
04/07/2005 |
ZYGOMA TIUNITE |
NOBEL BIOCARE USA LLC |
ELIZABETH MASON |
| K050350 |
04/29/2005 |
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) |
NOTAL VISION, INC. |
RICHARD E LIPPMAN |
| K050244 |
04/08/2005 |
MALE NATURAL RUBBER LATEX CONDOM |
NRS GLOBAL PARTNERS |
ELI J CARTER |
| K042506 |
04/05/2005 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K042505 |
04/05/2005 |
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
| K042565 |
04/11/2005 |
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K050866 |
04/27/2005 |
CENTRION 500 C-ARM SYSTEM |
OSTEOSYS CO., LTD. |
T. WHIT ATHEY |
| K041495 |
04/15/2005 |
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS |
PENTAFERTE S.P.A |
VITTORIO SERVIDORI |
| K050742 |
04/05/2005 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K050692 |
04/08/2005 |
FLXIS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K050762 |
04/22/2005 |
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
EGON PFEIL |
| K050794 |
04/28/2005 |
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| DEN050003 |
04/18/2005 |
PAXGENE BLOOD RNA SYSTEM |
PREANALYTIX GMBH |
JING ZHANG |
| K050488 |
04/01/2005 |
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES |
PROSURG, INC. |
ASHVIN DESAI |
| K050691 |
04/21/2005 |
R. POON MEDICAL PRODUCTS WHEELCHAIRS |
R. POON MEDICAL PRODUCTS CO., LTD. |
RICHARD GRAVER |
| K043143 |
04/22/2005 |
SAFEPICO |
RADIOMETER MEDICAL APS |
LENE MEINECHE MARNAES |
| K050533 |
04/26/2005 |
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K050414 |
04/11/2005 |
PLIX |
RESPIRONICS, INC. |
ZITA YURKO |
| K050423 |
04/22/2005 |
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) |
Roche Diagnostics |
DIMITRIS DEMIRTZOGLOU |
| K043529 |
04/08/2005 |
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K043474 |
04/27/2005 |
ACCU-CHEK AVIVA SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K050387 |
04/25/2005 |
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K050895 |
04/20/2005 |
SURPASSON P5 NEWTRON |
SATELEC |
PASCAL DUPEYRON |
| K050778 |
04/13/2005 |
TELEREHAD 2004 |
SCOTTCARE |
WAYNE STRIPE |
| K042449 |
04/18/2005 |
DOLPHIN INFLATION DEVICE |
SEDAT S.A. |
LAETITIA BERNARD |
| K050419 |
04/01/2005 |
QMS VANCOMYCIN |
SERADYN INC. |
JACK ROGERS |
| K050510 |
04/01/2005 |
ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
| K050401 |
04/28/2005 |
CERAMAGE |
SHOFU DENTAL CORP. |
DAVID MORAIS |
| K040757 |
04/13/2005 |
SIC PRO |
SIC INVENT AG |
GEORG SCHILLI |
| K050867 |
04/14/2005 |
SYNGO BODY PERFUSION-CT |
SIEMENS AG |
RUEDIGER KOERNER |
| K042018 |
04/15/2005 |
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
SIMPLY CLEAN AIR & WATER, INC. |
RAYMOND KOWALEC |
| DEN050001 |
04/18/2005 |
DECAPINOL ORAL RINSE |
SINCLAIR PHARMACEUTICALS LIMITED |
MICHAEL KILLEEN |
| K050462 |
04/26/2005 |
SBI HAND FIXATION SYSTEM (TM) |
SMALL BONE INNOVATIONS LLC |
DONALD GUTHNER |
| K050122 |
04/18/2005 |
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K050598 |
04/07/2005 |
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K050580 |
04/20/2005 |
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHLEEN BURNS |
| K050030 |
04/21/2005 |
ACTICOAT MOISTURE CONTROL DRESSING |
SMITH & NEPHEW, INC. |
TERRY C MCMAHON |
| K043495 |
04/22/2005 |
BABYPAC |
SMITHS MEDICAL INTERNATIONAL LTD., LUTON |
DONALD ALEXANDER |
| K050532 |
04/14/2005 |
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K050706 |
04/15/2005 |
HARMONY PORT SYSTEM, MODEL 1907 SERIES |
SPINAL CONCEPTS, INC. |
NOAH BARTSCH |
| K042958 |
04/08/2005 |
DUREX PLAY TINGLING LUBRICANT |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K042470 |
04/05/2005 |
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K041539 |
04/28/2005 |
COMPEL SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K050831 |
04/12/2005 |
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A |
STELLARTECH RESEARCH CORP. |
JAMES SANTOS |
| K050343 |
04/12/2005 |
REPROCESSED HARMONIC SCALPELS |
STERILMED, INC. |
BRUCE LESTER |
| K050515 |
04/05/2005 |
BONE BLOCK FIXATION SET |
STRAUMANN USA, INC. |
LINDA JALBERT |
| K050615 |
04/21/2005 |
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 |
STRYKER INSTRUMENTS |
BECKY DITTY |
| K043250 |
04/15/2005 |
STRYKER PATIENT SPECIFIC POLYMER IMPLANT |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
| K050624 |
04/11/2005 |
STRYKER SPINE AVS PL PEEK SPACER |
STRYKER SPINE |
SIMONA VOIC |
| K043533 |
04/01/2005 |
SURGICAL DESIGN CIRCUMCISION CLAMP |
SURGICAL DESIGN, INC. |
MOHAMMAD BASHIR |
| K050548 |
04/01/2005 |
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K050671 |
04/01/2005 |
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM |
SURGRX, INC. |
LINDA OLESON |
| K041515 |
04/08/2005 |
TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
| K050625 |
04/26/2005 |
VARELISA RECOMBI ANA PROFILE, MODEL 18496 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
SABINE KLUGBAUER |
| K050604 |
04/15/2005 |
KERR VPS IMPRESSION MATERIAL |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K050796 |
04/12/2005 |
AURORA DS, DS APPLICATOR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K050646 |
04/26/2005 |
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES |
SYNTHES (USA) |
KATHY ANDERSON |
| K050683 |
04/27/2005 |
SYNTHES (USA) 3.5MM CONICAL SCREWS |
SYNTHES (USA) |
KATHY ANDERSON |
| K050631 |
04/11/2005 |
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K050606 |
04/06/2005 |
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) |
SYNTHES (USA) |
KATHY ANDERSON |
| K050607 |
04/11/2005 |
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) |
SYNTHES (USA) |
KATHY ANDERSON |
| K050636 |
04/21/2005 |
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K043555 |
04/12/2005 |
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR |
SYNTHES (USA) |
KATHY ANDERSON |
| K050517 |
04/13/2005 |
JSZ-MULTIPURPOSE SOLUTION |
SZABOCSIK AND ASSOCIATES |
JOHN MSZABOCSIK |
| K041648 |
04/28/2005 |
NITI-S STENT & INTRODUCER, MODEL EOXXXX |
TAEWOONG MEDICAL CO., LTD |
JAMES HARVY KNAUSS |
| K050628 |
04/07/2005 |
ANSPACH COUPLER |
THE ANSPACH EFFORT, INC. |
WILLIAM G CONETY |
| K042767 |
04/27/2005 |
DATAPRO CLINICAL CHELISTRY ANALYZER |
THERMO ELECTRON CORPORATION |
BOLA NICHOLSON |
| K050619 |
04/26/2005 |
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K050485 |
04/07/2005 |
20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K050616 |
04/21/2005 |
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K050617 |
04/22/2005 |
21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K050663 |
04/08/2005 |
TRAXYLOC-1 SYSTEM |
TRAXYZ MEDICAL, INC. |
F. DAVID ROTHKOPF |
| K050540 |
04/29/2005 |
UCP RAPID DRUG SCREENING TESTS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K050815 |
04/26/2005 |
XACT.CARDIAC & XPRESS.CARDIAC |
ULTRASPECT LTD. |
DAN LAOR |
| K050743 |
04/13/2005 |
AQUAFLEX 2 (TEFILCON) CONTACT LENS |
UNILENS CORP., USA |
JOSEPHA BRUNO |
| K043253 |
04/08/2005 |
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K050321 |
04/18/2005 |
ONTRAK TESTCARD 9 |
VARIAN INC |
LORNA GAMBOA |
| K050511 |
04/14/2005 |
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K050474 |
04/14/2005 |
VEINNOVATIONS INFILTRATION SYSTEM |
VEINNOVATIONS, LLC |
ROSINA ROBINSON |
| K050972 |
04/29/2005 |
VISION-SCIENCES ENT-3000 SCOPE |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K043503 |
04/05/2005 |
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 |
VISX, INCORPORATED |
ALAN F RUSSELL |
| K043604 |
04/29/2005 |
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE |
VIVOMETRICS, INC. |
HOWARD M HOLSTEIN |
| K043083 |
04/18/2005 |
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K050819 |
04/11/2005 |
CHARLOTTE SNAP-OFF SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K043339 |
04/18/2005 |
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG |
XTREMI-T, LLC |
SHAWN T HUXEL |
| K050801 |
04/20/2005 |
URISCAN OPTIMA II URINE ANALYZER |
YD DIAGNOSTICS |
JERRI HOI |
| K050769 |
04/14/2005 |
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 |
Z-MEDICA CORPORATION |
ROBERT V PACKARD |
| K042118 |
04/29/2005 |
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K042092 |
04/12/2005 |
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K050450 |
04/04/2005 |
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES |
ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD |
KAREN ABELL |
| K043356 |
04/18/2005 |
WAGNER SL REVISION STEM LATERAL |
ZIMMER AUSTIN, INC. |
AUDREY SWEARINGTON |
| K050433 |
04/13/2005 |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM |
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
CINDY J DICKEY |
| K050101 |
04/15/2005 |
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 |
ZIMMER TRABECULAR |
ROBERT A POGGIE |
| K050723 |
04/20/2005 |
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS |
ZIMMER, INC. |
TONI KINGSLEY |
| K050761 |
04/11/2005 |
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM |
ZIMMER, INC. |
DARLENE BINKLEY |
| K042007 |
04/07/2005 |
ZOLL E SERIES DEFIBRILLATOR |
ZOLL MEDICAL CORP. |
SEAN REYNOLDS |
