FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K050500 |
06/27/2005 |
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
KIMBERLEY KLINE |
K051125 |
06/08/2005 |
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 |
ABBOTT LABORATORIES |
KIM SMITH-SERVANCE |
K051519 |
06/21/2005 |
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) |
ABBOTT LABORATORIES (PERCLOSE, INC.) |
ANN E LEONARD |
K050936 |
06/24/2005 |
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K050878 |
06/08/2005 |
ON CALL MULTI-DRUG HOME TEST CUP |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K042297 |
06/01/2005 |
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES |
ACTA VASCULAR SYSTEMS, INC. |
RICHARD M RUEDY |
K051351 |
06/08/2005 |
PRECEDENCE SPECT/CT IMAGING SYSTEM |
ADAC LABORATORIES |
COLEEN A COLEMAN |
K050428 |
06/14/2005 |
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) |
ADVANCED SPINAL TECHNOLOGIES, INC. |
JEFFREY R PERELMAN |
K042644 |
06/01/2005 |
AESKULISA TTG A AND AESKULISA TTG G |
AESKU, INC |
STANLEY AMMONS |
K051054 |
06/29/2005 |
VISULIZE FACTOR IX ANTIGEN KIT |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
K050953 |
06/29/2005 |
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE |
AIR SAFETY LTD |
PAUL DRYDEN |
K051554 |
06/29/2005 |
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
K043358 |
06/06/2005 |
REPROCESSED ULTRASONIC SCALPELS |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
K051167 |
06/01/2005 |
REVOLIX AND REVOLIX JR |
ALLMED SYSTEMS INC. |
PETER N ALLEN |
K050830 |
06/22/2005 |
ZODIAC SPINAL FIXATION SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
K051286 |
06/17/2005 |
ZODIAC SPINAL FIXATION SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
K050445 |
06/17/2005 |
AMS COLLAGEN DERMAL MATRIX |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
K051059 |
06/28/2005 |
AMSURE 100% SILICONE FOLEY CATHETER |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
K050919 |
06/14/2005 |
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P |
ANALOGIC CORP. |
DONALD SHERRATT |
K050236 |
06/27/2005 |
FISHVIEW |
APPLIED SPECTRAL IMAGING, LTD. |
DAN LAOR |
K043176 |
06/17/2005 |
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM |
ARC SURGICAL LLC. |
ED BOEHMER |
K033720 |
06/10/2005 |
ARI COLD SPRAY |
ARI |
RON ARKIN |
K050790 |
06/06/2005 |
SPOTCHEM II LDH TEST |
ARKRAY, INC. |
HELEN LANDICHO |
K051432 |
06/17/2005 |
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
K051219 |
06/29/2005 |
PUSHLOCK |
ARTHREX, INC. |
SALLY FOUST |
K050864 |
06/17/2005 |
PARALLAX ACRYLIC RESIN WITH TRACERS TA |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K051069 |
06/29/2005 |
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER |
ARTHROTEK, INC. |
GARY BAKER |
K051187 |
06/08/2005 |
REXEED SERIES DIALYZERS |
ASAHI KASEI MEDICAL CO., LTD. |
DAVID L WEST |
K050459 |
06/13/2005 |
ATRICURE ISOLATOR TRANSPOLAR PEN |
ATRICURE, INC. |
ELSA ABRUZZO |
K051250 |
06/09/2005 |
AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
K051392 |
06/29/2005 |
BTI-SCAN, VERSION 4.0 |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
LEYRE ZUNIGA HERNANDO |
K051168 |
06/29/2005 |
BARRX HALO 360 SYSTEM, MODEL 1100C-115A |
BARRX MEDICAL, INCORPORATED |
JONATHAN S KAHAN |
K051265 |
06/13/2005 |
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
K050374 |
06/15/2005 |
ADVIA IMS LITHIUM ASSAY |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
K051307 |
06/13/2005 |
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K051138 |
06/03/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K051109 |
06/15/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML |
BECTON, DICKINSON & CO. |
MINICA E GIGUERE |
K051183 |
06/21/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K051204 |
06/24/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K042084 |
06/15/2005 |
BIODERM SCIENCES WOUND HEALING SPRAY |
BIODERM SCIENCES, INC. |
EDWARD R GUBISH |
K050734 |
06/03/2005 |
COOL.CLICK |
BIOJECT, INC. |
MELANIE TALBERT |
K051411 |
06/29/2005 |
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
K050441 |
06/29/2005 |
TAPER 2 POROUS FEMORAL STEM |
BIOMET, INC. |
KACY ARNOLD |
K050877 |
06/24/2005 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR |
BIOSENSE WEBSTER, INC. |
MICHAEL JOHNSON |
K050799 |
06/29/2005 |
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS |
BIOSITE INCORPORATED |
RACHAEL S WILLIAMSON |
K051470 |
06/08/2005 |
REMOTE CARE MANAGEMENT SYSTEMS (RCMS) |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
K043548 |
06/14/2005 |
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
K051246 |
06/14/2005 |
CONSTRUX MINI PEEK VBR SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
K050805 |
06/20/2005 |
30 ML OR 60 ML PEDI-SYRINGE FILTER |
BLOOD PRODUCTS SPECIALTIES LLC |
ALAN A WALDMAN |
K050964 |
06/13/2005 |
PV 1900 SYNCHRO 0.016 GUIDEWIRE |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
RICK GAYKOWSKI |
K051361 |
06/16/2005 |
EASY CORE DETACHABLE BIOPSY SYSTEM |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M CAMERON |
K051179 |
06/08/2005 |
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 |
BOSTON SCIENTIFIC CORP. |
CATHERINE A PETERS |
K051504 |
06/16/2005 |
SPYSCOPE ACCESS AND DELIVERY CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER JOHNSON |
K050599 |
06/03/2005 |
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
VICTOR HAM |
K051254 |
06/22/2005 |
PERIPHERAL CUTTING BALLOON |
BOSTON SCIENTIFIC IVT |
RENUKA KRISHNAN |
K050931 |
06/15/2005 |
6 FR DL POWERPICC CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
K051417 |
06/30/2005 |
6 FR FL POWERHOHN AND POWERLINE CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
K050673 |
06/13/2005 |
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
K051228 |
06/10/2005 |
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG |
CARDIODYNAMICS INTERNATIONAL CORP. |
DENNIS HEPP |
K051283 |
06/23/2005 |
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE |
CARDIOPULMONARY CORP. |
JORDAN SCHRECK |
K050844 |
06/23/2005 |
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 |
K051207 |
06/21/2005 |
CAVEX ORTHOTRACE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K051293 |
06/14/2005 |
CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM |
CEREMED, INC. |
TADEUSZ WELLISZ |
K043558 |
06/06/2005 |
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A |
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. |
GEORGE SU |
K033591 |
06/03/2005 |
REPROCESSED TROCARS |
CLEAR MEDICAL, INC. |
MIKE KOVACS |
K051415 |
06/23/2005 |
ENDOTINE RIBBON |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
K051243 |
06/23/2005 |
JET BLUE BITE |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
K050998 |
06/15/2005 |
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 |
CONFLUENT SURGICAL,INC |
ERIC P ANKERUD |
K043296 |
06/06/2005 |
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING |
COVALON TECHNOLOGIES, INC. |
PAUL L GUILBAUD |
K050779 |
06/27/2005 |
CYNERGY MULTIPLEX LASER |
CYNOSURE, INC. |
GEORGE CHO |
K050928 |
06/29/2005 |
DADE THROMBIN REAGENT |
DADE BEHRING, INC. |
KATHELEEN A DRAY-LYONS |
K051202 |
06/23/2005 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K051460 |
06/15/2005 |
C.CAM-AC |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS SORENSEN |
K042891 |
06/29/2005 |
DATEX-OHMEDA OXY-AFR SENSOR |
DATEX-OHMEDA |
JOEL C KENT |
K050860 |
06/21/2005 |
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
K050208 |
06/14/2005 |
FRIADENT ESTHETICAP |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
K051462 |
06/24/2005 |
MODIFICATION TO: CERCON BASE |
DENTSPLY INTL. |
HELEN LEWIS |
K051084 |
06/13/2005 |
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE |
DENVER BIOMEDICALS, INC. |
NANCY SAUER |
K050523 |
06/15/2005 |
DIADEXUS PLAC TEST |
DIADEXUS, INC. |
Julie Blacklock |
K040290 |
06/01/2005 |
DIASORIN LIAISON CMV IGM/IGG |
DIASORIN S.P.A. |
DAVID M IKEDA |
K051258 |
06/01/2005 |
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 |
EASTMAN KODAK COMPANY |
CHRISTINE E EHMANN |
K051483 |
06/21/2005 |
KODAK DIRECTVIEW DR SYSTEM DETECTOR |
EASTMAN KODAK COMPANY |
CHRISTINE E EHMANN |
K051225 |
06/10/2005 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K051319 |
06/15/2005 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K051022 |
06/01/2005 |
GAMMAPLAN |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
K042686 |
06/16/2005 |
ENERGEX |
ENERGEX SYSTEMS, INC. |
TRISH LANDRY |
K051308 |
06/01/2005 |
MYLAB 70 ULTRASOUND IMAGING SYSTEM |
ESAOTE, S.P.A. |
CARRI GRAHAM |
K051036 |
06/02/2005 |
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P |
ETHICON ENDO-SURGERY, INC. |
RACHEL D AUSTIN |
K050845 |
06/29/2005 |
MONOCRYL PLUS ANTIBACTERIAL SUTURE |
ETHICON, INC. |
JENNIFER M PAINE |
K051379 |
06/17/2005 |
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT |
EV3 CORPORATION |
GLEN D SMYTHE |
K051335 |
06/21/2005 |
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS |
EXACTECH, INC. |
MARITZA ELIAS |
K040871 |
06/01/2005 |
FACEMASTER FACIAL TONING SYSTEM |
FACEMASTER OF BEVERLY HILLS, INC. |
JIM ENGLAND |
K050243 |
06/06/2005 |
IMMEDIA PROTHROMBIN TIME SYSTEM |
FARALLON MEDIAL INC |
JAMES MCKINLEY |
K050738 |
06/02/2005 |
FT FIBER OPTIC DELIVERY SYSTEMS |
FIBERTECH GMBH |
ARMIN KAUS |
K050424 |
06/23/2005 |
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 |
FIM MEDICAL |
DANIEL KAMM |
K050273 |
06/08/2005 |
FRESENIUS ART HEMOADSORPTION SYSTEM |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
K051449 |
06/16/2005 |
GE VIVID 7 WITH OR WITHOUT SUFFIX |
GE MEDICAL SYSTEMS |
ALLEN SCHUH |
K050583 |
06/21/2005 |
MODEL 250 SERIES MATERNAL/FETAL MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
K051367 |
06/20/2005 |
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
TYLER SEDONE |
K050178 |
06/28/2005 |
HBA1C ENZYMATIC ASSAY |
GENERAL ATOMICS |
HUAN TRAN |
K051471 |
06/29/2005 |
CARDIODAY |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
K051345 |
06/23/2005 |
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
K051166 |
06/07/2005 |
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET |
GLOVECO, INC. |
MICKY LIN |
K050713 |
06/06/2005 |
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
K051402 |
06/13/2005 |
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM |
GVI TECHNOLOGY PARTNERS |
KEVIN M MURROCK |
K043480 |
06/08/2005 |
ENHANCE CLITORAL STIMULATION AID |
GYNAVATIONS, INC. |
DAVID GLOTH |
K051103 |
06/07/2005 |
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY |
HAAG-STREIT USA, INC. |
EDUARDO MARCH |
K050277 |
06/07/2005 |
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
K051546 |
06/24/2005 |
BPCALIBRATOR MC3000/MC3100 |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
K051325 |
06/15/2005 |
WEBPAX, MODEL 200 |
HEART IMAGING TECHNOLOGIES, LLC |
ROBERT M JUDD |
K050858 |
06/29/2005 |
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM |
HEARTLAB, INC. |
RICHARD PETROCELLI |
K051154 |
06/20/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
HEBEI MANFUL IMPORT & EXPORT CO., LTD. |
YANCHAI ZHANG |
K043050 |
06/03/2005 |
HEMCON BANDAGE AND HEMCON BANDAGE OTC |
HEMCON, INC. |
JOHN W MORGAN |
K051006 |
06/07/2005 |
IBOND NEXT GENERATION |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
K050721 |
06/01/2005 |
ABX ERYTROL |
HORIBA ABX |
TIM LAWTON |
K051363 |
06/23/2005 |
RESTORATION MODULAR SYSTEM |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K051306 |
06/17/2005 |
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K050696 |
06/17/2005 |
MEDLITE C1 Q-SWITCHED ND:YAG LASER |
HOYA PHOTONICS, INC. |
JIM GREEN |
K050852 |
06/22/2005 |
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
ALBERT LIPPINCOTT |
K051189 |
06/08/2005 |
PREVAIL DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K051196 |
06/17/2005 |
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 |
IMPLEX CORP. |
MARCI HALEVI |
K050662 |
06/13/2005 |
QUANTA LITE SP100 ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
K051630 |
06/29/2005 |
SUPER VIEW DISPOSABLE BIOM LENS SET |
INSIGHT INSTRUMENTS, INC. |
MICHAEL ANNEN |
K051408 |
06/29/2005 |
INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS |
INTELIFUSE, INC. |
SHARON ROCKWELL |
K050538 |
06/07/2005 |
IMC DRAPES |
INTL. MEDSURG CONNECTION, INC. |
MANNY GUPTA |
K050915 |
06/07/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K050916 |
06/08/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K051037 |
06/28/2005 |
IMAGEQUBE PACS |
INTUITIVE IMAGING INFORMATICS, LLC |
DONALD MUNDT |
K050802 |
06/29/2005 |
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K051512 |
06/28/2005 |
CAC-127-8 CARDOAC ARRAY COIL |
INVIVO CORP. |
THOMAS SCHUBERT |
K050156 |
06/17/2005 |
WHS-1000 WOUND HEALING SYSTEM |
IYIA TECHNOLOGIES, INC. |
ALAN DONALD |
K051481 |
06/29/2005 |
JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
K051482 |
06/29/2005 |
JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
K051127 |
06/03/2005 |
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 |
KIKA MEDICAL INC. |
HOWARD HOSTEIN |
K051347 |
06/07/2005 |
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
K051521 |
06/28/2005 |
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
K050918 |
06/06/2005 |
KOO AMERICAS VALVE PEEP, MODEL KM-809 |
KOO AMERICAS, INC. |
WILLIAM SLEVIN |
K043314 |
06/20/2005 |
MANZI CLEANER SYSTEM |
LANGFORD IC SYSTEMS, INC. |
TERRY LANGFORD |
K051608 |
06/29/2005 |
STAR 50 MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
K043479 |
06/30/2005 |
MC+ PARTIAL VBR |
LDR SPINE USA |
BRIAN BURKINSHAW |
K043349 |
06/29/2005 |
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) |
LDR SPINE USA |
BRAIN BURKINSHAW |
K051387 |
06/10/2005 |
LEVO COMFORT II |
LEVO AG |
MARKUS BURGER |
K051088 |
06/24/2005 |
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHENG-I LIN |
K050733 |
06/13/2005 |
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
CHENG-I LIN |
K051416 |
06/16/2005 |
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA |
MALLINCKRODT MEDICAL |
PATRICK GARVEY |
K041177 |
06/23/2005 |
SYNTHACER; SYNTRICER |
MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG |
HANS-PETER WETTL |
K051499 |
06/22/2005 |
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
SALVADORE F PALOMARES |
K051247 |
06/16/2005 |
SONOTIP II ULTRASOUND NEEDLE SYSTEM |
MEDI-GLOBE CORP. |
SCOTT KARLER |
K050478 |
06/15/2005 |
MEDICON IMF-ORION SCREWS |
MEDICON, E.G. |
JOACHIM SCHMID |
K042164 |
06/09/2005 |
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) |
MEDLINE INDUSTRIES, INC. |
BRUCE GIBBINS |
K051448 |
06/29/2005 |
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) |
MEDOC LTD. ADVANCED MEDICAL SYSTEMS |
GEORGE J HATTUB |
K051349 |
06/23/2005 |
3.0T PROSTATE IMAGING SYSTEM |
MEDRAD, INC. |
LISA A EWING |
K050456 |
06/17/2005 |
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM |
MEDRAD, INC. |
GEOFF M FATZINGER |
K050371 |
06/07/2005 |
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER |
MEDRAD, INC. |
GEOFF M FATZINGER |
K051303 |
06/10/2005 |
BIO-CONSOLE, MODEL 560 |
MEDTRONIC PERFUSION SYSTEMS |
DAWN M STENSTROM |
K051105 |
06/09/2005 |
BASIS VERTEBRAL BODY SPACER |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K050809 |
06/14/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
K050082 |
06/06/2005 |
CENTERPIECE PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE, PHD. |
K051029 |
06/08/2005 |
STELTHSTATION WIRELESS SURGEON MOUSE |
MEDTRONIC SURGICAL NAVIGATION |
TINA DREILING |
K050438 |
06/02/2005 |
STEALTHSTATION SYSTEM UPDATE |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
TINA DREILING |
K050008 |
06/03/2005 |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
MENTOR CORP. |
DONNA A CRAWFORD |
K051321 |
06/13/2005 |
INVIEW |
METRIKA, INC. |
Erika B Ammirati |
K051425 |
06/22/2005 |
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K051560 |
06/28/2005 |
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K051074 |
06/06/2005 |
MAS IMMUNOSUPPRESSANT CONTROLS |
MICROGENICS CORP. |
LISA CHARTER |
K050954 |
06/28/2005 |
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
K050776 |
06/06/2005 |
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
K051007 |
06/16/2005 |
ACCU02 SYSTEM |
MITI CORP. |
JONATHAN S KAHAN |
K050072 |
06/13/2005 |
GOODKNIGHT 425ST |
NELLCOR PURITAN BENNETT, INC. |
JAMES BONDS |
K050603 |
06/09/2005 |
OLPUR DIALYZER, MODEL HD 190 |
NEPHROS, INC. |
NADIA C GREENIDGE |
K050784 |
06/01/2005 |
NICHOLS ADVANTAGE ALDOSTERONE ASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
Xie Qiyi |
K050406 |
06/08/2005 |
NOBELSPEEDY IMPLANTS |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
K050649 |
06/13/2005 |
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
WILLIAM F MCNALLY |
K050056 |
06/21/2005 |
MODEL 2500A PALMSAT PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI ROTH |
K051107 |
06/01/2005 |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
NONIN MEDICAL, INC. |
LORI M ROTH |
K050727 |
06/13/2005 |
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K050525 |
06/24/2005 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K050885 |
06/03/2005 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K051551 |
06/28/2005 |
SMALL INTESTINAL VIDEOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K051233 |
06/21/2005 |
OMRON MODEL 514N TYMPANIC THERMOMETER |
OMRON HEALTHCARE, INC. |
IWAO KOJIMA |
K050568 |
06/01/2005 |
ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN N CAMBRIA |
K050795 |
06/03/2005 |
IMBIBE BONE MARROW ASPIRATION NEEDLE |
ORTHOVITA, INC. |
JANICE M HOGAN |
K041382 |
06/17/2005 |
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER, PH.D. |
K050370 |
06/15/2005 |
PALOMAR LUXIR HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
K041496 |
06/30/2005 |
PENTATRASFU BLOOD TRANSFUSION SETS |
PENTAFERTE S.P.A |
VICTOR PEREIRA |
K051218 |
06/09/2005 |
MODIFICATION TO: UNICAP SPECIFIC IGE |
PHARMACIA DIAGNOSTICS AB |
MARTIN R MANN |
K043408 |
06/08/2005 |
PIEZOSURGERY DEVICE |
PIEZOSURGERY SRL |
Maria E Donawa |
K051464 |
06/24/2005 |
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) |
PLANMECA OY |
BOB PIENKOWSKI |
K051317 |
06/20/2005 |
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
K051318 |
06/17/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
K031196 |
06/07/2005 |
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM |
PRAXIM |
SHEILA HEMEON-HEYER |
K051245 |
06/17/2005 |
POLYFORM SYNTHETIC MESH |
PROXY BIOMEDICAL LTD. |
ELAINE DUNCAN |
K051017 |
06/29/2005 |
R-X-FIX EXTERNAL FIXATOR |
R-X-FIX |
J.D. WEBB |
K050767 |
06/09/2005 |
STERLING INTERFERENCE SCREW ST |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
K043574 |
06/03/2005 |
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 |
RENAL SOLUTIONS, INC. |
RICHARD CONFER |
K051383 |
06/17/2005 |
THE INCOURAGE SYSTEM |
RESPIRATORY TECHNOLOGIES, INCORPORATED |
MARIO NOZZARELLA |
K051284 |
06/22/2005 |
MD TURBO |
RESPIRICS, INC. |
EDWARD M BASILE |
K050759 |
06/15/2005 |
BIPAP AUTO |
RESPIRONICS, INC. |
ZITA A YURKO |
K050036 |
06/27/2005 |
FES CYCLE ERGOMETER, MODEL RT300-S |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
K051292 |
06/17/2005 |
ELECSYS RBC FOLATE HEMOLYZED REAGENT |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K050910 |
06/16/2005 |
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS |
ROEI MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHN |
K041897 |
06/01/2005 |
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 |
SCHAERER MAYFIELD USA, INC. |
TECK AWA |
K051050 |
06/29/2005 |
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
K051304 |
06/03/2005 |
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM |
SCIENCE SURGICAL CORPORATION |
JUDY F GORDON |
K042939 |
06/27/2005 |
CAPILLARY'S IMMUNOTYPING (PN 2100) |
Sebia, Inc. |
BOREK JANIK |
K051315 |
06/15/2005 |
MODIFICATION TO: SECTRA IDS5 WORKSTATION |
SECTRA IMTEC AB |
CARL ALLETTO |
K051444 |
06/20/2005 |
SENTINEL CHOLINESTERASE LIQUID |
SENTINEL CH. SRL |
DAVIDE SPADA |
K043031 |
06/13/2005 |
SERIM DIALYSATE MONITOR TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA A RUPCHOCK |
K051021 |
06/20/2005 |
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A |
SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
K051156 |
06/14/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW) |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHU XIAOAN |
K050925 |
06/01/2005 |
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE |
SHIMADZU CORP. |
RANDAL WALKER |
K050434 |
06/24/2005 |
SHL DISPOSABLE AUTOINJECTOR |
SHL MEDICAL, USA |
LUCIO GIAMBATTISTA |
K051133 |
06/01/2005 |
ARCADIS AVANTIC |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MICHAEL J ANDREWS |
K051123 |
06/03/2005 |
CALLOS IMPACT AND INJECT BONE VOID FILLER |
SKELETAL KINETICS, LLC |
DURAN YETKINLER |
K042630 |
06/27/2005 |
REVLIGHT SKIN CARE SYSTEM |
SKINCARE TECHNOLOGY INC. |
RICHARD O WOOD |
K043306 |
06/06/2005 |
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR |
SKYLARK DEVICE & SYSTEMS CO., LTD |
BETTY CHIEN |
K051326 |
06/15/2005 |
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K051557 |
06/30/2005 |
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K050870 |
06/03/2005 |
RIVA LIGHT CURE |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K050871 |
06/10/2005 |
RIVA PROTECT |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
K051008 |
06/15/2005 |
SET |
SOUTHERN DENTAL INDUSTRIES, LTD. |
RAY CAHILL |
K050283 |
06/30/2005 |
CREATININE LIQUICOLOR |
STANBIO LABORATORY |
KIRK JOHNSON |
K050266 |
06/30/2005 |
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR |
STANBIO LABORATORY |
KIRK JOHNSON |
K051374 |
06/23/2005 |
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM |
STEREOTAXIS, INC. |
KELLY ROWLAND |
K051220 |
06/14/2005 |
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
BRUCE R LESTER |
K050486 |
06/07/2005 |
PROTECT TOOTH DESENSITIZER |
SUNSTAR BUTLER |
RICHARD O WOOD |
K051027 |
06/29/2005 |
STALIF TT |
SURGICRAFT LTD. |
JANET M WEBB |
K041512 |
06/02/2005 |
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
K041514 |
06/03/2005 |
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
K041511 |
06/03/2005 |
TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
K041510 |
06/02/2005 |
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE |
SUTURES INDIA PRIVATE LIMITED |
L.G. CHANDRASEKHAR |
K050967 |
06/28/2005 |
VARELISA RECOMBI CTD SCREEN, MODEL 13096 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
K050397 |
06/09/2005 |
VELASMOOTH, SHAPER |
SYNERON MEDICAL LTD. |
DONALD E SEGAL |
K042415 |
06/09/2005 |
MENDEC SPINE |
TECRES SPA |
CHRISTINE BRAUER |
K051190 |
06/10/2005 |
XENFORM SOFT TISSUE REPAIR MATRIX |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
K051563 |
06/20/2005 |
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
K051094 |
06/06/2005 |
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE |
TERANG NUSA SDN BHD |
LOW CHIN GUAN |
K051334 |
06/03/2005 |
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER |
TERATECH CORP. |
CHARLES F HOTTINGER |
K050847 |
06/17/2005 |
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A |
THERATECH, INC. |
MICHAEL PRICE |
K051502 |
06/21/2005 |
SPI DENTAL IMPLANT |
THOMMEN MEDICAL, AG |
Floyd Larson |
K050114 |
06/09/2005 |
SUPERCATH Z3V |
TOGO MEDIKIT CO., LTD. |
KOZO NAGAYAMAB |
K051414 |
06/16/2005 |
EYE CUP, STERILE 1 AND NON STERILE |
TOLLOT PTY.LTD.(AAXIS PACIFIC) |
Kevin Walls |
K051500 |
06/17/2005 |
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K051331 |
06/27/2005 |
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
K050965 |
06/14/2005 |
TRANS1 AXIALIF SYSTEM |
TRANS1 INCORPORATED |
ROBERT L SHERIDAN |
K043377 |
06/01/2005 |
ZENO |
TYRELL, INC. |
DARLA J ELKIN |
K050947 |
06/01/2005 |
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
K050728 |
06/28/2005 |
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES |
USA INSTRUMENTS, INC. |
DAVID BROWN |
K051043 |
06/06/2005 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
K050763 |
06/01/2005 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
K051235 |
06/08/2005 |
ON TRAK TESTCARD |
VARIAN INC |
LORNA GAMBOA |
K051395 |
06/24/2005 |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
K043340 |
06/02/2005 |
EZ SMART |
VIP DIAGNOSTICS LLC |
DAVID L ROSEN |
K050803 |
06/30/2005 |
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES |
VITAID, LTD. |
PAUL E DRYDEN |
K051535 |
06/28/2005 |
MODIFICATION TO:REGISTRADO X-TRA |
VOCO GMBH |
GERALD W SHIPPS |
K050995 |
06/20/2005 |
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
LORRY HUFFMAN |
K051267 |
06/15/2005 |
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE |
W.L. GORE & ASSOCIATES, INC. |
JACQUELINE KALBACH |
K041096 |
06/03/2005 |
WAGNER STERISET STERILIZATION CONTAINER |
WAGNER GMBH |
LARA N SIMMONS |
K051399 |
06/30/2005 |
WAVELIGHT AURIGA |
WAVELIGHT LASER TECHNOLOGIE AG |
ALEXANDER POPP |
K050903 |
06/23/2005 |
XAWEX G 100 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K051148 |
06/21/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K051152 |
06/03/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K051491 |
06/30/2005 |
TRABECULAR METAL PRIMARY HIP PROSTHESIS |
ZIMMER, INC. |
DALENE T BINKLEY |
K051475 |
06/24/2005 |
ZOLL M SERIES 12SL ANALYSIS OPTION |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |