| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K050862 |
04/05/2005 |
3TP WORKSPACE |
3TP LLC |
MICHAEL KOCHIAN |
| K051041 |
04/25/2005 |
INSULIN PUMP |
ABBOTT DIABETES CARE INC. |
MARY ROSE |
| K050936 |
04/14/2005 |
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K050878 |
04/06/2005 |
ON CALL MULTI-DRUG HOME TEST CUP |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K050950 |
04/15/2005 |
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS |
ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS |
EFRAIM BIDAS |
| K051083 |
04/27/2005 |
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
| K050922 |
04/13/2005 |
ANS SCS ACCESSORY KIT |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K050979 |
04/19/2005 |
S4 SPINAL SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
| K051054 |
04/26/2005 |
VISULIZE FACTOR IX ANTIGEN KIT |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K051028 |
04/22/2005 |
BREEZE |
AFIKIM ELECTRIC VEHICLES |
AVNER FISHBEIN |
| K050953 |
04/15/2005 |
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE |
AIR SAFETY LTD |
PAUL DRYDEN |
| K051101 |
04/29/2005 |
VERIFY FLASH INTEGRATOR |
ALBERT BROWNE LTD. |
CYNTHIA J M. NOLTE |
| K051056 |
04/26/2005 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J M. NOLTE |
| K050985 |
04/19/2005 |
GLUCODR SUPERSENSOR SYSTEM |
ALL MEDICUS CO., LTD |
JE YOUNG CHANG |
| K050830 |
04/01/2005 |
ZODIAC SPINAL FIXATION SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
| K051044 |
04/25/2005 |
ARCTEC SEMIRIGID PLATING SYSTEM |
ALTIVA CORP. |
JOHN KAPTIAN |
| K051031 |
04/22/2005 |
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS |
AMERIWATER |
BRIAN R BOWMAN |
| K051059 |
04/26/2005 |
AMSURE 100% SILICONE FOLEY CATHETER |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K050919 |
04/12/2005 |
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P |
ANALOGIC CORP. |
DONALD SHERRATT |
| K051060 |
04/26/2005 |
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K051042 |
04/25/2005 |
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 |
ANGIOMETRX INC. |
TIM VERSPAGEN |
| K050969 |
04/18/2005 |
INCLOSE SURGICAL MESH SYSTEM |
ANULEX TECHNOLOGIES, INC |
TIM MILLER |
| K050864 |
04/05/2005 |
PARALLAX ACRYLIC RESIN WITH TRACERS TA |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K051069 |
04/26/2005 |
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER |
ARTHROTEK, INC. |
GARY BAKER |
| K050900 |
04/11/2005 |
MEDIOSTAR XT |
ASCLEPION LASER TECHNOLOGIES GMBH |
REINHARD THIEME |
| K051077 |
04/27/2005 |
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 |
ASEPTICO, INC. |
GRANT RAMALEY |
| K050874 |
04/06/2005 |
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K051011 |
04/21/2005 |
ENDOSSEOUS DENTAL IMPLANT ABUTMENT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K051046 |
04/25/2005 |
PAINACEA MODEL XR8 INFRARED HEAT LAMP |
ATLANTIS LUMINESCENT PRODUCTS, LLC |
JAMES HARVEY KNAUSS |
| K050832 |
04/01/2005 |
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT |
BARD PERIPHERAL VASCULAR, INC. |
DENNIS SALZMANN |
| K050948 |
04/15/2005 |
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
ANNE ZAVERTNIK |
| K050881 |
04/07/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GUIGUERE |
| K050946 |
04/15/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050865 |
04/05/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050982 |
04/19/2005 |
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K051091 |
04/28/2005 |
SYNTHOGRAFT |
BICON, INC. |
VINCENT J MORGAN |
| K051072 |
04/26/2005 |
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM |
BIO-RAD LABORATORIES, INC. |
WILLIAM G GUSTAFSON |
| K051030 |
04/22/2005 |
COAG-A-MATE MTX III |
BIOMERIEUX, INC. |
JOHN CUSACK |
| K050976 |
04/18/2005 |
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K050961 |
04/18/2005 |
RNA1C CONTROL FOR NYCOCARD HBA1C |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K050877 |
04/06/2005 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR |
BIOSENSE WEBSTER, INC. |
MICHAEL JOHNSON |
| K050971 |
04/18/2005 |
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) |
BIOVALVE TECHNOLOGIES, INC. |
SCOTT HUIE |
| K050840 |
04/01/2005 |
MODIFICATION TO DUET SYSTEM |
BIOVIEW LTD. |
DORIT WINITZ |
| K050892 |
04/08/2005 |
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
| K050964 |
04/18/2005 |
PV 1900 SYNCHRO 0.016 GUIDEWIRE |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
RICK GAYKOWSKI |
| K050863 |
04/05/2005 |
IMAGER II ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC CORP. |
Diane Brinza |
| K050996 |
04/20/2005 |
O-ARM IMAGING SYSTEM |
BREAKAWAY IMAGING, LLC |
WOLFGANG KRULL |
| K050931 |
04/14/2005 |
6 FR DL POWERPICC CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K050875 |
04/06/2005 |
U-BALLOON DILATION CATHETER |
C.R. BARD, INC. |
JOHN C KNORPP |
| K050987 |
04/19/2005 |
DIGITAL RADIOGRAPHY MODEL CXDI-40EG |
CANON, INC. |
SHEILA DRISCOLL |
| K050940 |
04/14/2005 |
PMP4 MEDICAL WEB CENTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K050853 |
04/04/2005 |
PMP4 SPIROPRO |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
NA'AMA OREN |
| K050994 |
04/19/2005 |
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
Cardinal Health |
SHARON NICHOLS |
| K050939 |
04/14/2005 |
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM |
CARDIOMEMS INC |
CAROL VIERLING |
| K051055 |
04/26/2005 |
INTRABEAM SYSTEM |
CARL ZEISS SURGICAL GMBH |
ROSINA ROBINSON |
| K050844 |
04/04/2005 |
750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K051013 |
04/21/2005 |
SPINEMED S200B/S200C |
CERT HEALTH SCIENCES, LLC |
TIM R EMSKY |
| K050826 |
04/01/2005 |
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS |
CETRO AMERICA |
MAYA CIANCIOLO |
| K050828 |
04/01/2005 |
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM |
CHURCH & DWIGHT CO., INC. |
STEPHEN C KOLAKOWSKY |
| K050951 |
04/15/2005 |
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 |
| K051038 |
04/25/2005 |
506 PATIENT MONITOR |
CIRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K051089 |
04/28/2005 |
GII SPINAL FIXATION SYSTEM |
CO-LIGNE AG |
DAVID W SCHLERF |
| K051085 |
04/28/2005 |
DOPPLER-BOX |
COMPUMEDICS GERMANY GMGH |
GEROLD WIDENHORN |
| K050998 |
04/20/2005 |
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 |
CONFLUENT SURGICAL,INC |
ERIC P ANKERUD |
| K050992 |
04/19/2005 |
CONMED IRRIGATION NOZZLE |
CONMED CORP. |
IRA DUESLER |
| K050829 |
04/01/2005 |
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
| K050923 |
04/13/2005 |
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR |
CONMED LINVATEC |
ELIZABETH PAUL |
| K051048 |
04/25/2005 |
SURGISIS STAPLE LINE REINFORCEMENT II |
COOK BIOTECH, INC. |
MARK BLEYER |
| K050889 |
04/06/2005 |
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH |
CRS MEDICAL DIAGNOSTICS INC. |
JOSEPH M MATTANO |
| K051081 |
04/27/2005 |
ESSENPACS |
CYMED ENGINEERING, INC. |
CARL ALLETTO |
| K050928 |
04/14/2005 |
DADE THROMBIN REAGENT |
DADE BEHRING, INC. |
KATHELEEN A DRAY-LYONS |
| K051087 |
04/28/2005 |
DIMENSION VISTA INTEGRATED SYSTEM |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K050860 |
04/05/2005 |
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K050851 |
04/04/2005 |
DELTA PUNCTUM PLUG |
DELTA LIFE SCIENCE, INC. |
GEORGE W MURRAY |
| K050959 |
04/18/2005 |
DELTON ILLUMINATING PIT AND FISSURE SEALING |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K050880 |
04/06/2005 |
DYRACT EXTRA RESTORATIVE |
DENTSPLY INTL. |
HELEN LEWIS |
| K051084 |
04/28/2005 |
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE |
DENVER BIOMEDICALS, INC. |
NANCY SAUER |
| K050991 |
04/19/2005 |
THE ODFS DROPPED FOOT STIMULATOR |
DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. |
TINA LECHMAN |
| K051024 |
04/22/2005 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K050888 |
04/07/2005 |
INTEGRA IMMOBILIZATION SYSTEM |
DIACOR, INC. |
GLENN N WATERMAN |
| K050827 |
04/01/2005 |
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) |
DIALYSIS SOLUTIONS, INC. |
MARCY MACDONALD |
| K050913 |
04/12/2005 |
DICK'S FORMALWEAR MALE LATEX CONDOM |
DICK'S FORMALWEAR INC. |
CURT STRENK |
| K050890 |
04/08/2005 |
ECC.O SYSTEM |
DIDECO S.R.L. |
BARRY SALL |
| K050974 |
04/18/2005 |
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K051014 |
04/21/2005 |
SILENT PARTNER SERIES OSA APPLIANCES |
DREAMWRX DENTAL LABORATORY |
NICOLAAS BESSELING |
| K050921 |
04/13/2005 |
EASYSTIM NMS-28 |
EASYMED INSTRUMENT CO., LTD. |
JEFFERY WU |
| K051022 |
04/22/2005 |
GAMMAPLAN |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K051075 |
04/27/2005 |
ENCORE REVERSE SHOULDER PROSTHESIS |
ENCORE MEDICAL, L.P. |
CHRISTIE SHUMAKER |
| K051002 |
04/20/2005 |
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER |
ETHICON ENDO-SURGERY, INC. |
GEORGIA C ABERNATHY |
| K051036 |
04/25/2005 |
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P |
ETHICON ENDO-SURGERY, INC. |
RACHEL D AUSTIN |
| K050845 |
04/04/2005 |
MONOCRYL PLUS ANTIBACTERIAL SUTURE |
ETHICON, INC. |
JENNIFER M PAINE |
| K050904 |
04/11/2005 |
CPAP HUMIDIFIER, MODEL HC238JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K050927 |
04/13/2005 |
RT019 INSPIRATORY/EXPIRATORY FILTER |
FISHER & PAYKEL HEALTHCARE, LTD. |
RENETA MONEY |
| K050997 |
04/20/2005 |
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE |
FLEXUSPINE, INC. |
COREY HARBOLD |
| K051062 |
04/26/2005 |
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO |
FLOWCARDIA, INC. |
RICHARD SPANO |
| K050907 |
04/11/2005 |
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P |
FUJINON, INC. |
JOSEPH AZARY |
| K051052 |
04/25/2005 |
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) |
GALIL MEDICAL LTD. |
JONATHAN S KAHAN |
| K051092 |
04/28/2005 |
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 |
04/01/2005 |
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K050837 |
04/01/2005 |
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE |
GE HEALTHCARE |
JOEL KENT |
| K051026 |
04/22/2005 |
MARS HOLTER ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
| K050943 |
04/14/2005 |
GE VIEWPOINT |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K050850 |
04/04/2005 |
XPAND CORPECTOMY SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K051103 |
04/29/2005 |
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY |
HAAG-STREIT USA, INC. |
EDUARDO MARCH |
| K050932 |
04/14/2005 |
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM |
HAND INNOVATIONS, INC. |
ERNIE HERNANDEZ |
| K050858 |
04/05/2005 |
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM |
HEARTLAB, INC. |
RICHARD PETROCELLI |
| K051006 |
04/20/2005 |
IBOND NEXT GENERATION |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| K050854 |
04/04/2005 |
PALACOS LV+G |
HERAEUS KULZER GMBH |
CHRISTIAN TUCHSCHERER |
| K050855 |
04/04/2005 |
PALAMED G |
HERAEUS KULZER GMBH |
CHRISTIAN TUCHSCHERER |
| K051025 |
04/22/2005 |
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K051079 |
04/27/2005 |
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY |
HOSPICARE, INC. |
Yuliya Matlin |
| K050852 |
04/04/2005 |
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
ALBERT LIPPINCOTT |
| K050926 |
04/13/2005 |
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 |
IDEV TECHNOLOGIES, INC. |
SHANNON HURD |
| K050983 |
04/19/2005 |
IRMA TRUPOINT CREATININE CONTROL KIT |
INTERNATIONAL TECHNIDYNE CORPORATION |
NANCY RING |
| K050861 |
04/05/2005 |
PEEK CAS |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
| K050970 |
04/18/2005 |
MILO DENTAL IMPLANT SYSTEM |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K050915 |
04/12/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K050916 |
04/12/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K051037 |
04/25/2005 |
IMAGEQUBE PACS |
INTUITIVE IMAGING INFORMATICS, LLC |
DONALD MUNDT |
| K050838 |
04/01/2005 |
THE LF-P CERAMIC SYSTEM |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
| K050999 |
04/20/2005 |
YI XIN STERILE SYRINGE FOR SINGLE USE |
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP |
YUN YUAN GAO |
| K050944 |
04/14/2005 |
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K050984 |
04/19/2005 |
BIOPLANT |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K050897 |
04/08/2005 |
NAVIPRO SHOULDER SOFTWARE MODULE |
KINAMED, INC. |
VINEET K SARIN |
| K050918 |
04/12/2005 |
KOO AMERICAS VALVE PEEP, MODEL KM-809 |
KOO AMERICAS, INC. |
WILLIAM SLEVIN |
| K051061 |
04/26/2005 |
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
MEATHER VIELE |
| K051067 |
04/26/2005 |
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) |
LEMAITRE VASCULAR, INC. |
AMY WATZKE |
| K050989 |
04/19/2005 |
AWQ-104 |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K051020 |
04/22/2005 |
ES-160 |
LHASA OMS, INC. |
MARK W SHEEHAN |
| K051058 |
04/26/2005 |
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K051088 |
04/28/2005 |
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K050988 |
04/19/2005 |
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
| K050945 |
04/14/2005 |
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K051034 |
04/22/2005 |
URYXXON 200 URINE ANALYZER |
MACHEREY-NAGEL GMBH & CO., KG. |
EDUARDO MARCH |
| K050973 |
04/18/2005 |
MODIFICATION TO: VOYAGER LINUX |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K050963 |
04/18/2005 |
GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN |
MDS NORDION |
ROSS KACHANIWSKY |
| K051065 |
04/26/2005 |
RAYCELL X-RAY BLOOD IRRADIATOR |
MDS NORDION |
ROSS KACHANIWSKY |
| K050934 |
04/14/2005 |
MODUS TITANIUM OSTEOSYNTHESIS SYSTEM |
MEDARTIS, INC. |
FLOYD G LARSON |
| K050873 |
04/06/2005 |
CANALIZER HYDROPHILIC GUIDE WIRE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KRISTINE LIBERACKI |
| K050990 |
04/19/2005 |
REMREST HEATED HUMIDIFIER |
MEDICAL INDUSTRIES AMERICA, INC. |
KEITH THEISEN |
| K050993 |
04/19/2005 |
MMS VIDEO OPTION |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
| K050933 |
04/14/2005 |
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 |
MEDISURG LTD. |
RICHARD J FUGO |
| K051082 |
04/27/2005 |
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K051040 |
04/25/2005 |
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
MEDTRONIC PERFUSION SYSTEMS |
BRUCE BACKLUND |
| K051039 |
04/25/2005 |
BASIS SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K050981 |
04/19/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TRECHAME |
| K051029 |
04/22/2005 |
STELTHSTATION WIRELESS SURGEON MOUSE |
MEDTRONIC SURGICAL NAVIGATION |
TINA DREILING |
| K051018 |
04/21/2005 |
INTERMEZZO IMPLANT SYSTEMS |
MEGAGEN CO., LTD. |
DAE KYU CHANG |
| K050924 |
04/13/2005 |
MERETE DUOTHREADTM BONE SCREW |
MERETE MEDICAL GMBH |
JENIK RADON |
| K050962 |
04/18/2005 |
MERIT PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
JERRIE HENDRICKSON |
| K051090 |
04/28/2005 |
X-CHANGE |
MEYRA |
KIRK MACKENZIE |
| K050941 |
04/14/2005 |
BRIX WHEELCHAIR |
MEYRA, INC. |
KIRK MACKENZIE |
| K051074 |
04/27/2005 |
MAS IMMUNOSUPPRESSANT CONTROLS |
MICROGENICS CORP. |
LISA CHARTER |
| K051100 |
04/29/2005 |
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K050954 |
04/15/2005 |
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K051073 |
04/26/2005 |
MIDIVIEW SERIES OF MICROENDOSCOPES |
MILLENNIUM DEVICES, INC. |
JOSEPH LIBRIZZI |
| K050952 |
04/15/2005 |
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR |
MINNTECH CORP. |
LYNN LUEDERS |
| K051007 |
04/20/2005 |
ACCU02 SYSTEM |
MITI CORP. |
JONATHAN S KAHAN |
| K050842 |
04/01/2005 |
AGCEL WOUND DRESSING,AGCEL BURN DRESSING |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
BOB STILLMAN |
| K050896 |
04/08/2005 |
H12+ HOLTER RECORDER |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K050975 |
04/18/2005 |
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN |
NANO-DITECH CO. |
SUSAN D GOLDSTEIN-FALK |
| K050882 |
04/07/2005 |
NEWDEAL ANKLE NAIL |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K050833 |
04/01/2005 |
ELECTRODE JUNCTION BOX, MODEL JE-921A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K050920 |
04/12/2005 |
CZR PRESS LF STAINS |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K051009 |
04/21/2005 |
HUBER CLEAR SAFETY INFUSION SET |
NOW MEDICAL DISTRIBUTION, INC. |
CHRISTINE EMANNUEL |
| K050857 |
04/05/2005 |
BIB PTA BALLOON CATHETER |
NUMED, INC. |
JODI GIJANTO |
| K050885 |
04/07/2005 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K050856 |
04/05/2005 |
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM |
OPHTHOCARE LTD. |
DORIT WINITZ |
| K051095 |
04/28/2005 |
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
OPTICAL CONNECTION, INC. |
GAROLD L EDWARDS |
| K050966 |
04/18/2005 |
PIVOT BIPOLAR FEMORAL HEAD |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K050868 |
04/06/2005 |
MAXLOCK |
ORTHOHELIX SURGICAL DESIGNS, INC. |
EDWARD A KROLL |
| K051032 |
04/22/2005 |
TITANIUM-HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K051053 |
04/25/2005 |
OSCAR, MODEL OE3000DB |
ORTHOSONICS, LTD. |
T. WHIT ATHEY |
| K051047 |
04/25/2005 |
COLLOSS E BONE VOID FILLER |
OSSACUR AG |
KRISTI KISTNER |
| K051093 |
04/28/2005 |
OSTEOPORE PCL SCAFFOLD |
OSTEOPORE, INC. |
ALEXANDER YEO |
| K050866 |
04/05/2005 |
CENTRION 500 C-ARM SYSTEM |
OSTEOSYS CO., LTD. |
T. WHIT ATHEY |
| K050929 |
04/14/2005 |
THE HERMES SYSTEM |
PALAISTRA SYSTEMS INC. |
PATRIC GORA |
| K050980 |
04/19/2005 |
ULTRASONIC BIO-MICROSCOPE, MODEL P60 |
PARADIGM MEDICAL INDUSTRIES, INC. |
EDWARD A KROLL |
| K050955 |
04/15/2005 |
LIFESIGN DXPRESS, MODEL LSR2000 |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K050968 |
04/18/2005 |
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K051017 |
04/21/2005 |
R-X-FIX EXTERNAL FIXATOR |
R-X-FIX |
J.D. WEBB |
| K050869 |
04/06/2005 |
MODIFICATION TO ABL800 FLEX |
RADIOMETER MEDICAL APS |
MARK A HELLER |
| K050899 |
04/11/2005 |
BIOGEL LATEX STERILE POWDER-FREE GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K050841 |
04/01/2005 |
FRAXEL SR LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K050884 |
04/07/2005 |
ADAPTER CABLE |
REMINGTON MEDICAL, INC. |
DON ROSVOLD |
| K051097 |
04/29/2005 |
GERATHERM SOS-RESCUE BLANKET |
RG ENT., INC. |
RONALD G LETOURNEAU |
| K051102 |
04/29/2005 |
OMNIPICC PI |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
| K050872 |
04/06/2005 |
ACCU-CHEK INTEGRA SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K050910 |
04/11/2005 |
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS |
ROEI MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHN |
| K050883 |
04/07/2005 |
SAFERSLEEP SYSTEM |
SAFER SLEEP LLC |
STEVEN CHERNOFF |
| K051012 |
04/21/2005 |
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 |
| K051019 |
04/22/2005 |
SAFETY NEEDLE |
SARSTEDT, INC. |
PETER RUMSWINKEL |
| K050895 |
04/08/2005 |
SURPASSON P5 NEWTRON |
SATELEC |
PASCAL DUPEYRON |
| K051050 |
04/25/2005 |
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
| K051063 |
04/26/2005 |
POLYAXIAL HEMISPHERICAL SPINAL SCREWS |
SCIENT'X |
J.D. WEBB |
| K050836 |
04/01/2005 |
CRP DIAGNOSTIC ASSAY |
SENTINEL CH. SRL |
Maria E Donawa |
| K051010 |
04/21/2005 |
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 |
SEPTODONT |
WAYNE H MATELSKI |
| K051021 |
04/22/2005 |
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A |
SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K050925 |
04/13/2005 |
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE |
SHIMADZU CORP. |
RANDAL WALKER |
| K050867 |
04/06/2005 |
SYNGO BODY PERFUSION-CT |
SIEMENS AG |
RUEDIGER KOERNER |
| K050849 |
04/04/2005 |
HA COATED LAG SCREW |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K050938 |
04/14/2005 |
KNEE FUSION NAIL |
SMITH & NEPHEW, INC. |
LAURIE JORDAN |
| K051086 |
04/28/2005 |
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K050898 |
04/11/2005 |
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX |
SMITH & NEPHEW, INC. |
KAREN PROVENCHER |
| K050870 |
04/06/2005 |
RIVA LIGHT CURE |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
| K050871 |
04/06/2005 |
RIVA PROTECT |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
| K051008 |
04/20/2005 |
SET |
SOUTHERN DENTAL INDUSTRIES, LTD. |
RAY CAHILL |
| K050957 |
04/15/2005 |
EUTROCHAR |
SPECIAL DEVICES, INC. |
JOSEPH J SPRANZA III |
| K051045 |
04/25/2005 |
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 |
SPECTRX, INC. |
WILLIAM M VONDERSMITH |
| K051000 |
04/20/2005 |
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE |
SPINAL CONCEPTS, INC. |
NOAH BARTSCH |
| K051096 |
04/29/2005 |
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 |
ST. JUDE MEDICAL, DAIG DIVISION, INC. |
MIKE BURNSIDE |
| K050831 |
04/01/2005 |
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A |
STELLARTECH RESEARCH CORP. |
JAMES SANTOS |
| K050956 |
04/15/2005 |
TBR IDEA CONIC/CONIC |
SUDIMPLANT SA |
DIDIER SAILHAN |
| K051027 |
04/22/2005 |
STALIF TT |
SURGICRAFT LTD. |
JANET M WEBB |
| K050967 |
04/18/2005 |
VARELISA RECOMBI CTD SCREEN, MODEL 13096 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
| K051035 |
04/22/2005 |
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS |
SYNERGEYES |
RICHARD E LIPPMAN |
| K051049 |
04/25/2005 |
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR |
SYNTHES (USA) |
KATHY ANDERSON |
| K050891 |
04/08/2005 |
TOX A/B QUICK CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K051094 |
04/28/2005 |
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE |
TERANG NUSA SDN BHD |
LOW CHIN GUAN |
| K050846 |
04/04/2005 |
B-CAD SYSTEM, VERSION 1.0 |
THE MEDIPATTERN CORPORATION |
PATRICIA A MILBANK |
| K050847 |
04/04/2005 |
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A |
THERATECH, INC. |
MICHAEL PRICE |
| K051066 |
04/26/2005 |
THERATEST EL-ANA PROFILES |
THERATEST LABORATORIES, INC. |
MARIUS TEDORESCU |
| DEN050004 |
04/05/2005 |
TAG-IT CYSTIC FIBROSIS KIT |
TM BIOSCIENCE CORPORATION |
NANCY KRUNIC |
| K051023 |
04/22/2005 |
TOPEZ TOTAL ANKLE REPLACEMENT |
TOPEZ ORTHOPEDICS, INC |
LEWIS WARD |
| K050848 |
04/04/2005 |
TORNIER ELBOW PROSTHESIS |
TORNIER |
Mireille Lemery |
| K050965 |
04/18/2005 |
TRANS1 AXIALIF SYSTEM |
TRANS1 INCORPORATED |
ROBERT L SHERIDAN |
| K050930 |
04/14/2005 |
E.P.T. CERTAINTY PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K050947 |
04/15/2005 |
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K051043 |
04/25/2005 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K051169 |
04/29/2005 |
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K051071 |
04/26/2005 |
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K050972 |
04/18/2005 |
VISION-SCIENCES ENT-3000 SCOPE |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K050906 |
04/11/2005 |
VITALCARE I.V. ADMINISTRATION SET |
VITALCARE GROUP, INC. |
MICHAEL MCAVENIA |
| K050995 |
04/20/2005 |
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
LORRY HUFFMAN |
| DEN050002 |
04/07/2005 |
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K050960 |
04/18/2005 |
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT |
WALLAC OY |
GUNNEL LAAKSONEN |
| K050903 |
04/11/2005 |
XAWEX G 100 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K050843 |
04/01/2005 |
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
XOFT, INC. |
Kathy O'Shaughnessy |
| K050887 |
04/07/2005 |
GONGDONG DISPOSABLE VAGINAL SPECULUM |
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
WEIFENG ZHONG |
| K051064 |
04/26/2005 |
ZIEHM QUANTUM |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K050937 |
04/14/2005 |
TRABECULAR METAL ACETABULAR REVISION SHELLS |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K051098 |
04/29/2005 |
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K051076 |
04/27/2005 |
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
| K051068 |
04/26/2005 |
ZUTRON COLONOSCOPE STIFFENING DEVICE |
ZUTRON MEDICAL |
JORDAN HARTONG |
