| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K050534 |
05/20/2005 |
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT LABORATORIES |
Joanna Develter |
| K051213 |
05/27/2005 |
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS |
ABBOTT LABORATORIES INC |
ANDREA RUTH |
| K050546 |
05/20/2005 |
ACON +/- MIDSTREAM PREGNANCY TEST |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K050593 |
05/06/2005 |
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K051083 |
05/12/2005 |
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
| K050922 |
05/18/2005 |
ANS SCS ACCESSORY KIT |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K042450 |
05/12/2005 |
STERRAD NX CHALLENGE PACK |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH M ASCENZI |
| K050813 |
05/04/2005 |
ABC 2 SCREW |
AESCULAP, INC. |
KATHY A RACOSKY |
| K050693 |
05/26/2005 |
ACCENT |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K050060 |
05/04/2005 |
LAGUNA PEDICLE SCREW SYSTEM |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K050557 |
05/27/2005 |
AMT NANOCATH |
AMERICAN MEDICAL TECHNOLOGIES, INC. |
MICHAEL RENICK |
| K050654 |
05/02/2005 |
AMSINO I.V. START KIT |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K050656 |
05/02/2005 |
AMSINO SUTURE REMOVAL KIT |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K051060 |
05/26/2005 |
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K043191 |
05/16/2005 |
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH |
ANGIOLOGICA B. M. SRL |
ROBERTO MANCA |
| K050259 |
05/27/2005 |
ARTHREX BIO-PIN |
ARTHREX, INC. |
ANN WATERHOUSE |
| K050749 |
05/12/2005 |
ARTHREX TAK FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
| K050900 |
05/16/2005 |
MEDIOSTAR XT |
ASCLEPION LASER TECHNOLOGIES GMBH |
REINHARD THIEME |
| K051077 |
05/03/2005 |
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 |
ASEPTICO, INC. |
GRANT RAMALEY |
| K050874 |
05/05/2005 |
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K040145 |
05/04/2005 |
ATA HCM MONOPLACE HYPERBARIC SYSTEM |
ATA HYPERBARIC CHAMBER MANUFACTURING |
HUMPHREY KILLAM |
| K051046 |
05/10/2005 |
PAINACEA MODEL XR8 INFRARED HEAT LAMP |
ATLANTIS LUMINESCENT PRODUCTS, LLC |
JAMES HARVEY KNAUSS |
| K043249 |
05/25/2005 |
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARK |
| K050814 |
05/06/2005 |
ATRIUM ICAST COVERED STENT |
ATRIUM MEDICAL CORP. |
JOSEPH P PAOLO |
| K051201 |
05/26/2005 |
E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY |
BARCOVIEW |
LIEVEN DE WANDEL |
| K050948 |
05/18/2005 |
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
ANNE ZAVERTNIK |
| K050495 |
05/02/2005 |
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) |
BAXTER HEALTHCARE CORP., BIOSCIENCE |
RON LAGERQUIST |
| K050632 |
05/26/2005 |
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K050119 |
05/06/2005 |
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT |
BECKMAN COULTER, INC. |
KIM WALKER |
| K050780 |
05/12/2005 |
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML |
BECTON DICKINSON & CO. |
LINDA DILLON |
| K050881 |
05/12/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GUIGUERE |
| K050946 |
05/27/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050865 |
05/20/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050982 |
05/24/2005 |
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K041984 |
05/11/2005 |
ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT |
BEST SANITIZERS, INC. |
RICHARD M ORMSBEE |
| K051072 |
05/12/2005 |
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM |
BIO-RAD LABORATORIES, INC. |
WILLIAM G GUSTAFSON |
| K043067 |
05/31/2005 |
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 |
BIOARRAY SOLUTIONS LTD |
KEVIN WYCKOFF |
| K050596 |
05/13/2005 |
QUANTIA A1-AT |
BIOKIT S.A. |
JOAN GUIXER |
| K043005 |
05/03/2005 |
MODIFICATION TO MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K050816 |
05/12/2005 |
VITEK 2 GRAM POSITIVE MEROPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K050976 |
05/23/2005 |
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K050251 |
05/27/2005 |
BALANCE HIP SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K050961 |
05/13/2005 |
RNA1C CONTROL FOR NYCOCARD HBA1C |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K043542 |
05/18/2005 |
BIOPRO TARA FEMORAL RESURFACING COMPONENT |
BIOPRO, INC. |
DAVID MRAK |
| K050305 |
05/23/2005 |
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 |
BIOSCREEN MEDICAL INC. |
JIMMY LIANG |
| K050892 |
05/11/2005 |
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K050684 |
05/20/2005 |
ATLANTIS PV |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
| K050389 |
05/25/2005 |
ULTRA-SOFT SV BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
ANGIE BYLAND |
| K042543 |
05/17/2005 |
IPLAN! DIGITAL TEMPLATING |
BRAINLAB AG |
RAINER BIRKENBACH |
| K050996 |
05/05/2005 |
O-ARM IMAGING SYSTEM |
BREAKAWAY IMAGING, LLC |
WOLFGANG KRULL |
| K050006 |
05/27/2005 |
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO |
C.R. BARD, INC. |
DEBORAH L HERRINGTON |
| K050185 |
05/26/2005 |
POWERHOHN AND POWERLINE CATHETERS |
C.R. BARD, INC. |
CHRLES MORREALE |
| K050875 |
05/26/2005 |
U-BALLOON DILATION CATHETER |
C.R. BARD, INC. |
JOHN C KNORPP |
| K050853 |
05/04/2005 |
PMP4 SPIROPRO |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
NA'AMA OREN |
| K043518 |
05/11/2005 |
RADIOPAQUE BONE CEMENT |
Cardinal Health |
SHARON NICHOLS |
| K051055 |
05/23/2005 |
INTRABEAM SYSTEM |
CARL ZEISS SURGICAL GMBH |
ROSINA ROBINSON |
| K050129 |
05/17/2005 |
CELLERATION MIST THERAPY SYSTEM 5.1 |
CELLERATION, INC. |
DAVID BREMSETH |
| K050065 |
05/27/2005 |
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES |
CIBA VISION CORPORATION |
PENNY NORTHCUTT, RAC |
| K051085 |
05/05/2005 |
DOPPLER-BOX |
COMPUMEDICS GERMANY GMGH |
GEROLD WIDENHORN |
| K050470 |
05/06/2005 |
CONCENTRIC EMBOLIC PEARLS |
CONCENTRIC MEDICAL, INC. |
JEAN M CAILLOUETTE |
| K050829 |
05/06/2005 |
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
| K050923 |
05/18/2005 |
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR |
CONMED LINVATEC |
ELIZABETH PAUL |
| K050246 |
05/19/2005 |
SIS DERMAL AUGMENTATION STRAND |
COOK BIOTECH, INC. |
MARK BLEYER |
| K043509 |
05/05/2005 |
GUNTHER TULIP VENA CAVA FILTER SET |
COOK, INC. |
EARL E KNIGHT III |
| K050717 |
05/13/2005 |
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K051081 |
05/12/2005 |
ESSENPACS |
CYMED ENGINEERING, INC. |
CARL ALLETTO |
| K050080 |
05/05/2005 |
CYNOSUREA ECLILITE AND ECLILITE U |
CYNOSURE, INC. |
GEORGE CHO |
| K050650 |
05/16/2005 |
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 |
CYTYC SURGICAL PRODUCTS |
JIM TALBOT |
| K050665 |
05/02/2005 |
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) |
DADE BEHRING, INC. |
DONNA A WOLF |
| K050610 |
05/25/2005 |
SALUTE FIXATION SYSTEM |
DAVOL INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
| K050098 |
05/23/2005 |
DDAT OMT |
DDAT(UK) LTD |
PETER LIOYD |
| K043330 |
05/16/2005 |
POLYPROPILENE SURGICAL SUTURES |
DEMETECH CORP. |
ARTHUR WARD |
| K050959 |
05/11/2005 |
DELTON ILLUMINATING PIT AND FISSURE SEALING |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K050315 |
05/16/2005 |
DELTA HUMERAL CUPS |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI D ROGERS |
| K041059 |
05/17/2005 |
EPI-MAX |
DERMAGENICS, INC. |
STEVE MONROE |
| K050888 |
05/23/2005 |
INTEGRA IMMOBILIZATION SYSTEM |
DIACOR, INC. |
GLENN N WATERMAN |
| K051232 |
05/20/2005 |
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER |
DIDECO S.R.L. |
BARRY SALL |
| K050890 |
05/05/2005 |
ECC.O SYSTEM |
DIDECO S.R.L. |
BARRY SALL |
| K043409 |
05/05/2005 |
ACCUCHANGER |
DIREX SYSTEMS CORP. |
LARISA GERSTEIN |
| K042610 |
05/16/2005 |
DR. THEISS ALERGOL POLLEN BLOCKER CREAM |
DR. THEISS NATURWAREN GMBH |
STUART PORTNOY |
| K050248 |
05/25/2005 |
ELECTRODE |
ELECTRAMOLD |
E.W. JOHNSON |
| K051075 |
05/27/2005 |
ENCORE REVERSE SHOULDER PROSTHESIS |
ENCORE MEDICAL, L.P. |
CHRISTIE SHUMAKER |
| K043489 |
05/19/2005 |
ENPATH DEFLECTABLE CATHETER |
ENPATH MEDICAL INCORPORATED |
KARYL D HASKELL |
| K050672 |
05/02/2005 |
ERCHONIA EVRL LASER |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
| K051002 |
05/17/2005 |
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER |
ETHICON ENDO-SURGERY, INC. |
GEORGIA C ABERNATHY |
| K050788 |
05/13/2005 |
EVERLIFE |
EVERLIFE MEDICAL INSTRUMENT CO., LTD. |
JEN KE-MIN |
| K050660 |
05/12/2005 |
FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS |
FIRST QUALITY HYGIENIC, INC. |
ROBERT J STAAB |
| K043149 |
05/25/2005 |
FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) |
FIRSTLINE, LLC. |
COLETTE PERCHES |
| K050904 |
05/25/2005 |
CPAP HUMIDIFIER, MODEL HC238JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K050556 |
05/11/2005 |
ALUMINA HEAD |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K050907 |
05/19/2005 |
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P |
FUJINON, INC. |
JOSEPH AZARY |
| K051052 |
05/06/2005 |
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K033262 |
05/27/2005 |
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) |
GAMBRO RENAL PRODUCTS |
KAE MILLER |
| K043342 |
05/27/2005 |
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR |
GAMBRO RENAL PRODUCTS |
KAE MILLER |
| K051092 |
05/25/2005 |
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC |
GE HEALTHCARE |
JOEL C KENT |
| K050835 |
05/06/2005 |
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K050093 |
05/13/2005 |
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RONALD N BLASKI |
| K050731 |
05/19/2005 |
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
| K050943 |
05/23/2005 |
GE VIEWPOINT |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K050850 |
05/26/2005 |
XPAND CORPECTOMY SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K050071 |
05/11/2005 |
MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE |
H.B.M. USA CO.,INC. |
GORDON X HU |
| K050658 |
05/27/2005 |
RESO-PAC PERIODONTAL DRESSING |
HAGER WORLDWIDE, INC. |
DANIEL J MANELLI |
| K041360 |
05/05/2005 |
ALDAHOL III HIGH-LEVEL DISINFECTANT |
HEALTHPOINT, LTD. |
NORM MINER, PHD |
| K051153 |
05/18/2005 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
HEBEI MANFUL IMPORT & EXPORT CO., LTD. |
YANCHAI ZHANG |
| K051025 |
05/13/2005 |
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K051079 |
05/19/2005 |
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY |
HOSPICARE, INC. |
Yuliya Matlin |
| K050926 |
05/09/2005 |
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 |
IDEV TECHNOLOGIES, INC. |
SHANNON HURD |
| K042431 |
05/27/2005 |
PROCON2 |
INCONTINENT CONTROL DEVICES, INC. |
NYLE ELLIOTT |
| K050741 |
05/16/2005 |
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT |
IND DIAGNOSTIC INC. |
JASON PENG |
| K051341 |
05/27/2005 |
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 |
INION LTD. |
HANNA MARTTILA |
| K050171 |
05/04/2005 |
IT NASAL MASK |
INNOMED TECHNOLOGIES |
FRANK PELC |
| K050521 |
05/02/2005 |
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S |
INNTEC, INC. |
Gary Syring |
| K050715 |
05/12/2005 |
QUANTA PLEX ANCA PROFILE |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K051182 |
05/19/2005 |
INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
INOVEL LLC |
WILLIAM WAWRZYNIAK |
| K050661 |
05/02/2005 |
HEMOSIL FACTOR II DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K050720 |
05/11/2005 |
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 |
INTEGRA NEUROSCIENCES |
NANCY A MATHEWSON |
| K050983 |
05/16/2005 |
IRMA TRUPOINT CREATININE CONTROL KIT |
INTERNATIONAL TECHNIDYNE CORPORATION |
NANCY RING |
| K050861 |
05/27/2005 |
PEEK CAS |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
| K050756 |
05/05/2005 |
SKIPPER AND SKIPPER RACE GUIDEWIRE |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
MELISSA SOMMERFELD |
| K050453 |
05/27/2005 |
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 |
IVOCLAR VIVADENT, INC. |
DONNA HARNETT |
| K050669 |
05/26/2005 |
JEIL BONE FIXATION SYSTEM |
JEIL MEDICAL CORPORATION |
DANIEL KAMM |
| K050838 |
05/04/2005 |
THE LF-P CERAMIC SYSTEM |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
| K050130 |
05/13/2005 |
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM |
KERBEROS PROXIMAL SOLUTIONS, INC. |
TOM MASON |
| K050897 |
05/24/2005 |
NAVIPRO SHOULDER SOFTWARE MODULE |
KINAMED, INC. |
VINEET K SARIN |
| K050261 |
05/26/2005 |
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING |
KINETIC CONCEPTS, INC. |
CHRISTY OVIATT |
| K050051 |
05/16/2005 |
ARMAND ENDOSCOPE HOLDER |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
| K043484 |
05/16/2005 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
DAVID W SCHLERF |
| K051067 |
05/27/2005 |
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) |
LEMAITRE VASCULAR, INC. |
AMY WATZKE |
| K050638 |
05/31/2005 |
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES |
LENSTEC, INC. |
LUIS RUIZ |
| K050499 |
05/17/2005 |
PROBLOC, HN SERIES AND PROLONG, PL SERIES |
LIFE-TECH, INC. |
JEFF KASOFF |
| K043197 |
05/20/2005 |
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
MARY ELLEN HOLDEN |
| K050612 |
05/04/2005 |
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE |
LIGHTSPEED TECHNOLOGY, INC. |
STEVEN SENIA |
| K050519 |
05/17/2005 |
ADVANCED TURBO DRIVE SYSTEM |
LINVATEC CORP. |
ELIZABETH PAUL |
| K050735 |
05/23/2005 |
MC6A |
MACAN ENGINEERING CO. |
RICH GARRETT |
| K050973 |
05/17/2005 |
MODIFICATION TO: VOYAGER LINUX |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K042534 |
05/10/2005 |
MARINA MEDICAL FINGER PROTECTORS |
MARINA MEDICAL INSTRUMENTS, INC. |
JAY MANSOUR |
| K050252 |
05/11/2005 |
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K050332 |
05/27/2005 |
SURGI-WRAP MAST BIORESORBABLE SHEET |
MAST BIOSURGERY USA INC. |
KENNETH K KLEINHENZ |
| K050963 |
05/20/2005 |
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN |
MDS NORDION |
ROSS KACHANIWSKY |
| K051065 |
05/26/2005 |
RAYCELL X-RAY BLOOD IRRADIATOR |
MDS NORDION |
ROSS KACHANIWSKY |
| K050934 |
05/05/2005 |
MODUS TITANIUM OSTEOSYNTHESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K050561 |
05/04/2005 |
WINDSURFER |
MEDCON LTD. |
ELI M ORBACH |
| K050873 |
05/26/2005 |
CANALIZER HYDROPHILIC GUIDE WIRE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
| K050990 |
05/02/2005 |
REMREST HEATED HUMIDIFIER |
MEDICAL INDUSTRIES AMERICA, INC. |
KEITH THEISEN |
| K050993 |
05/26/2005 |
MMS VIDEO OPTION |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
| K051040 |
05/24/2005 |
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
MEDTRONIC PERFUSION SYSTEMS |
BRUCE BACKLUND |
| K051039 |
05/12/2005 |
BASIS SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K050981 |
05/17/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TRECHAME |
| K050484 |
05/04/2005 |
BASIS SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARME |
| K050022 |
05/05/2005 |
MEDX HOME |
MEDX ELECTRONICS, INC. |
ANITA SALTMARCHE |
| K050924 |
05/27/2005 |
MERETE DUOTHREADTM BONE SCREW |
MERETE MEDICAL GMBH |
JENIK RADON |
| K050962 |
05/06/2005 |
MERIT PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
JERRIE HENDRICKSON |
| K041823 |
05/10/2005 |
PIONEER U121 SERIES CPAP |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K050812 |
05/05/2005 |
90XL INSTRUMENTATION SYSTEM |
MESA LABORATORIES, INC. |
TODD ROMERO |
| K043586 |
05/06/2005 |
LASER SYS*STIM 540, MODEL ME 540 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K051090 |
05/13/2005 |
X-CHANGE |
MEYRA |
KIRK MACKENZIE |
| K050941 |
05/05/2005 |
BRIX WHEELCHAIR |
MEYRA, INC. |
KIRK MACKENZIE |
| K051252 |
05/27/2005 |
MICROPUMP MP-101 |
MICREL MEDICAL DEVICES S.A. |
ALEXANDRE TSOUKALIS |
| K051100 |
05/11/2005 |
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K050322 |
05/17/2005 |
MICROTEK EQUIPMENT DRAPES |
MICROTEK MEDICAL, INC. |
THOMAS BONNER |
| K050595 |
05/23/2005 |
FT2000 SEQUENCER FOR MUSCLE STIMULATOR |
MIDWEST DEVELOPMENT |
STEPHEN GORSKI |
| K043036 |
05/06/2005 |
NON-STICK ELECTRODE |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
ROBERT STILLMAN |
| K050786 |
05/09/2005 |
BARRIER SURGICAL GOWNS |
MOLNLYCKE HEALTH CARE |
JOHN CLAY |
| K051203 |
05/25/2005 |
BLUELEX |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K042595 |
05/04/2005 |
SPIRO'AIR |
MORGAN SCIENTIFIC, INC. |
PATRICK MORGAN |
| K050469 |
05/13/2005 |
EZ-STIK ELECTRODES |
NAIMCO, INC. |
ROBERT L MCCLURE |
| K050594 |
05/15/2005 |
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE |
NANO-DITECH CO. |
SUSAN D GOLDSTEIN-FALK |
| K042912 |
05/17/2005 |
INTERX5000 |
NEURO RESOURCE GROUP, INC. |
KRISTA OAKES |
| K050702 |
05/17/2005 |
NEUROSYSTEMS 1TM MONITOR |
NEUROSYSTEMS LLC |
JAMES R PETITE JR. |
| K050882 |
05/27/2005 |
NEWDEAL ANKLE NAIL |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K050312 |
05/09/2005 |
AMIGO INSULIN PUMP |
NIPRO DIABETES SYSTEMS, INC. |
CLARENCE ODOM |
| K050014 |
05/05/2005 |
HEMONIR TM |
NIR DIAGNOSTICS, INC. |
CYNTHIA A SINCLAIR |
| K050356 |
05/05/2005 |
COMPRESSION ANASTOMOSIS RING (CAR) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
| K050393 |
05/04/2005 |
THE GUIDED SURGERY CONCEPT |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K050705 |
05/19/2005 |
TIUNITE IMPLANTS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K050920 |
05/11/2005 |
CZR PRESS LF STAINS |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K041184 |
05/03/2005 |
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION |
NTI-TSS, INC. |
JAMES BOYD |
| K042729 |
05/17/2005 |
DERMACYN WOUND IRRIGATION |
OCULUS INNOVATIVE SCIENCES, INC. |
MOANISHA DESHMUKH |
| K041161 |
05/03/2005 |
MICROCYN WOUND CARE DRESSING |
OCULUS INNOVATIVE SCIENCES, INC. |
MANISHA S DESHMUKH |
| K042977 |
05/10/2005 |
LASIK EYE DRAPE |
ODYSSEY MEDICAL, INC. |
IVAN HARLAN |
| K050503 |
05/12/2005 |
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LARUA STORMS-TYLER |
| K050541 |
05/09/2005 |
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY |
OMNIGUIDE COMMUNICATIONS, INC. |
IRINA KULINETS |
| K050454 |
05/27/2005 |
OMNITECH FULGURATING ELECTRODE |
OMNITECH SYSTEMS, INC. |
JON D BARRETT |
| K050856 |
05/31/2005 |
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM |
OPHTHOCARE LTD. |
DORIT WINITZ |
| K043125 |
05/04/2005 |
ORION DIAGNOSTICA UNIQ PINP RIA |
ORION DIAGNOSTICA OY |
ANNIKKA RANTAMA |
| K050868 |
05/27/2005 |
MAXLOCK |
ORTHOHELIX SURGICAL DESIGNS, INC. |
EDWARD A KROLL |
| K051181 |
05/23/2005 |
CUSTOM-HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K051032 |
05/23/2005 |
TITANIUM-HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K050680 |
05/13/2005 |
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 |
OSTAR MEDITECH CORP. |
STEVEN CHANG |
| K050929 |
05/20/2005 |
THE HERMES SYSTEM |
PALAISTRA SYSTEMS INC. |
PATRIC GORA |
| K050980 |
05/26/2005 |
ULTRASONIC BIO-MICROSCOPE, MODEL P60 |
PARADIGM MEDICAL INDUSTRIES, INC. |
EDWARD A KROLL |
| K051170 |
05/23/2005 |
GEMINI GXL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
RAE ANN FARROW |
| K050573 |
05/04/2005 |
NEUROLAC NERVE GUIDE |
Polyganics BV |
JAN NIEUWENHUIS |
| K050754 |
05/18/2005 |
PRECIMED CANNULATED SCREW SYSTEM |
PRECIMED, INC. |
BARBARA LYONS |
| K041971 |
05/20/2005 |
WIMRT MODULE FOR ARTP PLANNING SYSTEM |
PRODIGM GROUP, INC. |
LEE POTTS |
| K050029 |
05/10/2005 |
CARDIOMPO TEST |
PROGNOSTIX, INC. |
THOMAS M JACKSON |
| K050678 |
05/20/2005 |
MOTIFMESH SOFT TISSUE PATCH |
PROXY BIOMEDICAL LTD. |
ELAINE DUNCAN |
| K051126 |
05/19/2005 |
CARDIOSCOPE SONOPLUS 3000 |
PULSONIC AG, MEDICAL TECHNOLOGY |
JAY MANSOUR |
| K050789 |
05/27/2005 |
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX |
R AND D MEDICAL, LLC |
FLOYD G LARSON |
| K043218 |
05/10/2005 |
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX |
RADIOMETER MEDICAL APS |
LENE MEINECHE MARNAES |
| K050179 |
05/17/2005 |
RANDOX BENZODIAZEPINE CLASS ASSAY |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K050884 |
05/19/2005 |
ADAPTER CABLE |
REMINGTON MEDICAL, INC. |
DON ROSVOLD |
| K050775 |
05/10/2005 |
RESSCAN |
RESMED LTD. |
DAVID D'CRUZ |
| K050872 |
05/02/2005 |
ACCU-CHEK INTEGRA SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K050748 |
05/20/2005 |
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
| K050686 |
05/04/2005 |
CARDIOVIT AT-10PLUS |
SCHILLER AG |
MARKUS BUETLER |
| K050348 |
05/27/2005 |
CO VERTEBRAL BODY REPLACEMENT |
SCIENT'X |
J.D. WEBB |
| K051063 |
05/23/2005 |
POLYAXIAL HEMISPHERICAL SPINAL SCREWS |
SCIENT'X |
J.D. WEBB |
| K050736 |
05/05/2005 |
IMORGON ULTRASOUND PACS SOLUTIONS |
SEA RIDGE SOFTWARE, INC. |
GARY J ALLSEBROOK |
| K051158 |
05/16/2005 |
ENCOR 7 GAUGE |
SENORX, INC. |
AMY BOUCLY |
| K051010 |
05/02/2005 |
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 |
SEPTODONT |
WAYNE H MATELSKI |
| K051139 |
05/13/2005 |
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K050849 |
05/04/2005 |
HA COATED LAG SCREW |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K050938 |
05/04/2005 |
KNEE FUSION NAIL |
SMITH & NEPHEW, INC. |
LAURIE JORDAN |
| K051086 |
05/31/2005 |
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K050898 |
05/25/2005 |
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
| K050166 |
05/26/2005 |
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT |
SMITHS MEDICAL |
CHRISTOPHER TURNBULL |
| K050471 |
05/12/2005 |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K050605 |
05/03/2005 |
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 |
SPACELABS MEDICAL INC. |
AL VAN HOUDT |
| K050957 |
05/18/2005 |
EUTROCHAR |
SPECIAL DEVICES, INC. |
JOSEPH J SPRANZA III |
| K050600 |
05/12/2005 |
MINILOC SAFETY INFUSION SET |
SPECIALIZED HEALTH PRODUCTS, INTL. |
Mark Nelson |
| K050528 |
05/19/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K051000 |
05/19/2005 |
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE |
SPINAL CONCEPTS, INC. |
NOAH BARTSCH |
| K051173 |
05/27/2005 |
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K051096 |
05/17/2005 |
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 |
ST. JUDE MEDICAL, DAIG DIVISION, INC. |
MIKE BURNSIDE |
| K041540 |
05/05/2005 |
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K043592 |
05/23/2005 |
REPROCESSED ENDOSCOPIC TROCAR |
STERILMED, INC. |
BRUCE R LESTER |
| K043466 |
05/10/2005 |
PAINPUMP2 |
STRYKER INSTRUMENTS |
JENNIFER MARS |
| K050753 |
05/18/2005 |
STRYKER DISCMONITOR |
STRYKER INSTRUMENTS |
JEAN W SHEPPARD |
| K043442 |
05/31/2005 |
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE |
STRYKER INSTRUMENTS |
JEAN SHEPPARD |
| K050718 |
05/26/2005 |
DDRCOMBI TRAUMA |
SWISSRAY INTERNATIONAL, INC. |
JOHN MONAHAN |
| K042606 |
05/27/2005 |
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE |
SYNTHES (USA) |
KATHY ANDERSON |
| K050608 |
05/18/2005 |
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K050589 |
05/04/2005 |
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K050325 |
05/05/2005 |
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE |
TECHNOMED EUROPE |
RENE RONCKEN |
| K042421 |
05/09/2005 |
URITEK 151 URINE ANALYZER, MODEL TC-151 |
TECO DIAGNOSTICS |
TONG S CHIAH |
| K051118 |
05/31/2005 |
MODEL TL-360 POWER SCOOTER |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
| K051116 |
05/31/2005 |
MODEL TL-560 POWER SCOOTER |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
Ke-Min Jen |
| K050128 |
05/13/2005 |
VITALWARE VMS |
TELEVITAL, INC. |
GRACE BARTOO |
| K050418 |
05/16/2005 |
TISSUE FIXATION SYSTEM |
TFS MANUFACTURING PTY LTD |
ALASTAIR DOWLING |
| K050846 |
05/26/2005 |
B-CAD SYSTEM, VERSION 1.0 |
THE MEDIPATTERN CORPORATION |
PATRICIA A MILBANK |
| K050058 |
05/17/2005 |
THEKEN REVEAL VBR SYSTEM |
THEKEN SURGICAL,LLC |
RANDY THEKEN |
| K042990 |
05/10/2005 |
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERLIE |
| K042988 |
05/12/2005 |
RAPID ONE STEP BUPRENORPHINE TEST CARD |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERLIE |
| DEN050004 |
05/09/2005 |
TAG-IT CYSTIC FIBROSIS KIT |
TM BIOSCIENCE CORPORATION |
NANCY KRUNIC |
| K050012 |
05/06/2005 |
VENTANA IMAGE ANALYSIS SYSTEM |
TRIPATH IMAGING, INC. |
BRYAN TUCKER |
| K050464 |
05/11/2005 |
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 |
ULTI MED, INC. |
CAROLE STAMP |
| K050930 |
05/12/2005 |
E.P.T. CERTAINTY PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K050116 |
05/09/2005 |
UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES |
UNIQSAFE BIOMEDITECH CO., LTD. |
JENNIFER REICH |
| K043198 |
05/27/2005 |
VANGUARD REPROCESSED ARTHROSCOPIC WANDS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K050168 |
05/18/2005 |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
| K050146 |
05/27/2005 |
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K043084 |
05/02/2005 |
PREMERE DELIVERY SHEATH, MODEL PDS |
VELOCIMED INC. |
JOHN CARLINE |
| K043044 |
05/06/2005 |
ANTI-I.V. ENTERAL FEEDING SYSTEM |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K040916 |
05/04/2005 |
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE |
VITALCARE GROUP, INC. |
MICHAEL MCAVENIA |
| DEN050002 |
05/19/2005 |
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K043203 |
05/11/2005 |
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K043234 |
05/25/2005 |
LIGHT DRAPE |
WRAPPED IN COMFORT |
JANE GETSLA |
| K043073 |
05/04/2005 |
PROCOTYL-E ACETABULAR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K051064 |
05/26/2005 |
ZIEHM QUANTUM |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K050766 |
05/26/2005 |
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K050937 |
05/11/2005 |
TRABECULAR METAL ACETABULAR REVISION SHELLS |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K050105 |
05/17/2005 |
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS |
ZIMMER, INC. |
BRANDON HIPSHER |
| K051076 |
05/13/2005 |
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
