FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K060684 |
04/24/2006 |
ADPER PROMPT, ADPER PROMPT L-POP |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
K060768 |
04/21/2006 |
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS |
ABBOTT DIABETES CARE INC. |
MARIA E TREJO |
K060466 |
04/21/2006 |
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
K053481 |
04/14/2006 |
KELO-COTE SPRAY |
ADVANCED BIO-TECHNOLOGIES, INC. |
STEVEN CHERNOFF |
K060366 |
04/07/2006 |
THE AMO OPHTHALMIC SURGICAL SYSTEM |
ADVANCED MEDICAL OPTICS, INC. |
TONI ELLIOTT |
K060492 |
04/07/2006 |
AESCULAP CRANIOFACIAL PLATE AND SCREW |
AESCULAP, INC. |
MATTHEW M HULL |
K053187 |
04/27/2006 |
AMPLATZER NOODLEWIRE GUIDEWIRE |
AGA MEDICAL CORP. |
PATRICIA A LAFORET |
K053117 |
04/10/2006 |
EZ-OX PLUS |
AIR LIQUIDE HEALTHCARE AMERICA |
ANGIE BEYER |
K060761 |
04/28/2006 |
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
K060145 |
04/14/2006 |
FDS INTIMATE AND INTIMATE WARMING LUBRICANT |
ALBERTO-CULVER USA, INC. |
RICK MAIN |
K051438 |
04/04/2006 |
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) |
ALLIANCE MEDICAL, INC. |
MOIRA BARTON |
K052527 |
04/12/2006 |
NEUROPROBES |
ALPHA OMEGA ENGINEERING, LTD. |
SHLOMO PUNDAK |
K060308 |
04/26/2006 |
COOLGARD 3000 |
ALSIUS CORP. |
KENNETH A COLLINS |
K060314 |
04/06/2006 |
ROTATING GAMMA SYSTEM. GAMMA ART-6000 |
AMERICAN RADIOSURGERY, INC. |
DAN OLIVIER |
K060382 |
04/19/2006 |
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 |
AMERIFLO CORP. |
MATTHEW THIE |
K053407 |
04/05/2006 |
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M |
ANALYTICAL INDUSTRIES, INC. |
PATRICK J PRINDIBLE |
K060887 |
04/28/2006 |
ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K060629 |
04/07/2006 |
GELPORT BLUNT TIP TROCAR SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K060800 |
04/07/2006 |
SEEKER/SPARK ULTRASOUND SYSTEM |
Ardent Sound, Inc. |
PAUL JAEGER |
K060865 |
04/24/2006 |
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
K060309 |
04/06/2006 |
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES |
ARROW INTL., INC. |
KAREN PROVENCHER |
K053543 |
04/03/2006 |
ARTHREX ARTHOERESIS IMPLANT |
ARTHREX, INC. |
ANN WATERHOUSE |
K060823 |
04/10/2006 |
ARTHROCARE WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K060461 |
04/28/2006 |
V-505 INFA WARMER |
ATOM MEDICAL INC |
MARY STANIEWICZ |
K053589 |
04/13/2006 |
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING |
BARD ACCESS SYSTEMS, INC. |
MICHAELA RIVKOWICH |
K060733 |
04/24/2006 |
SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 |
BARRIERMED, INC. |
VICTOR RAGUCCI |
K060169 |
04/21/2006 |
BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
K060470 |
04/12/2006 |
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 |
BAYER HEALTHCARE |
ROGER SONNEMBURG |
K053612 |
04/26/2006 |
DRI-STAT ACID PHOSPHATASE REAGENT |
BECKMAN COULTER, INC. |
ERI HIRUMI |
K060774 |
04/21/2006 |
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 |
BECKMAN COULTER, INC. |
CAROLYN ANDERSON |
K060935 |
04/28/2006 |
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K060217 |
04/12/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML |
BECTON DICKINSON & CO. |
MONICA E GIGUERE |
K060447 |
04/26/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) |
BECTON DICKINSON & CO. |
MONICA E GIGUERE |
K060444 |
04/12/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K060257 |
04/14/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K052457 |
04/13/2006 |
PICSI SPERM SELECTION DEVICE |
BIOCOAT, INC. |
JAMES B JOHNSTON |
K060815 |
04/18/2006 |
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT |
BIOFORM MEDICAL, INC. |
JAMES S MILLER |
K052996 |
04/28/2006 |
POROUS TITANIUM ACETABULAR SHELLS |
BIOMET MANUFACTURING CORP. |
ALLISON KOSKEY |
K060807 |
04/24/2006 |
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM |
BIOTRONIK, INC. |
Jon Brumbaugh |
K060655 |
04/04/2006 |
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H |
BIOTRONIK, INC. |
Jon Brumbaugh |
K051984 |
04/10/2006 |
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 |
BOSTON SCIENTIFIC CORP. |
DEBBIE MCINTIRE |
K060947 |
04/19/2006 |
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
K060960 |
04/12/2006 |
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
SARA L COON |
K060959 |
04/12/2006 |
SYMMETRY BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
ANGELA BYLAND |
K060658 |
04/10/2006 |
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
K052843 |
04/17/2006 |
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
K060962 |
04/19/2006 |
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 |
BYRNE MEDICAL, INC. |
J. HARVEY KNAUSS |
K052322 |
04/10/2006 |
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 |
C.R. BARD, INC. |
ROBIN DRAGO |
K060636 |
04/19/2006 |
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE |
C.R. BARD, INC. |
JULIE J BASSETT |
K060341 |
04/14/2006 |
SHERLOCK TIP LOCATION SYSTEM (TLS) |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K060703 |
04/04/2006 |
PMP4 BP PRO BLOOD PRESSURE MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K060167 |
04/19/2006 |
ATRIA 3100, ATRIA 6100 |
CARDIAC SCIENCE CORPORATION |
CHERYL SHEA |
K053263 |
04/25/2006 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 |
CARDIONET, INC |
JACK GAIKWAD |
K060866 |
04/28/2006 |
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS |
CARMEL PHARMA AB. |
KJELL ANDREASSON |
K060089 |
04/27/2006 |
TULIP DISPOSABLE CANNULAS |
CELL BIO-SYSTEMS, INC. |
CHRISTINE EMANUEL |
K052643 |
04/11/2006 |
EPICERAM |
CERAGENIX CORPORATION |
CARL GENBERG |
K050826 |
04/10/2006 |
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS |
CETRO AMERICA |
MAYA CIANCIOLO |
K060828 |
04/19/2006 |
MODIFICATION TO ENDOTINE RIBBON |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
K050674 |
04/25/2006 |
PHYSIOGLOVE ES |
COMMWELL LTD. |
JONATHAN S KAHN |
K060570 |
04/13/2006 |
HEMOGLOBIN ALC CONTROL |
COMPASS BIOSCIENCE |
CARTER GRANDJEAN |
K061021 |
04/28/2006 |
ENTAKE STANDARD AND SAFETY PEG SYSTEM |
CONMED CORP. |
BETH A ZIS |
K060717 |
04/25/2006 |
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
K060714 |
04/06/2006 |
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR |
CONMED LINVATEC |
ELIZABETH PAUL |
K060877 |
04/27/2006 |
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX |
CORDIS CORP. |
KAREN WILK |
K060302 |
04/11/2006 |
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED |
CORDIS EUROPA, N.V. |
HARM HOVINGA |
K053415 |
04/25/2006 |
LESIONPOINT RF CANNULA |
COSMAN MEDICAL, INC. |
MICHAEL ARNOLD |
K060804 |
04/18/2006 |
COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING |
COVALON TECHNOLOGIES LTD. |
JACQUES LEMMETTI |
K060555 |
04/21/2006 |
SPRAYGENIX CRYO ABLATION SYSTEM |
CRYMED TECHNOLOGIES, INC. |
TIM ASKEW |
K051842 |
04/14/2006 |
GREEN LOVE MALE CONTRACEPTIVE (CONDOM) |
CUPID CONDOM, LTD. |
K.K. GOYAL |
K060878 |
04/13/2006 |
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP |
CURAMEDICAL, BV |
WILLIAM GREENROSE |
K060628 |
04/06/2006 |
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K053577 |
04/14/2006 |
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K060385 |
04/06/2006 |
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT |
DADE BEHRING, INC. |
YUK-TING LEWIS |
K060548 |
04/06/2006 |
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK |
DADE BEHRING, INC. |
PAMELA A JURGA |
K060654 |
04/28/2006 |
DSI PINS AND WIRES |
DELTA SURGICAL INSTRUMENTS, INC. |
DANDENIA ZABAT |
K060359 |
04/14/2006 |
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 |
DENKA SEIKEN CO., LTD. |
TOSHIMI MATSUNAGA |
K060377 |
04/26/2006 |
DR DISPOSABLE PROPHY ANGLE MODEL H310 |
DENTAL RESOURCES |
BRYAN NICHOLS |
K060640 |
04/24/2006 |
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM |
DENTAMERICA |
ERIC HUANG |
K060837 |
04/10/2006 |
IN-OVATION C |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
K060696 |
04/14/2006 |
ACCLAIM TOTAL ELBOW SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K060139 |
04/28/2006 |
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
K060140 |
04/24/2006 |
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
K060929 |
04/28/2006 |
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 |
DIAGNOSTIC PRODUCTS CORPORATION |
DEBORAH L MORRIS |
K050913 |
04/04/2006 |
DICK'S FORMALWEAR MALE LATEX CONDOM |
DICK'S FORMALWEAR INC. |
CURT STRENK |
K060039 |
04/12/2006 |
INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS |
Draeger Medical Systems, Inc. |
KAREN IORIO |
K060223 |
04/12/2006 |
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM |
Draeger Medical Systems, Inc. |
KAREN A IORIO |
K060254 |
04/04/2006 |
MODIFICATION TO INFINITY EXPLORER |
Draeger Medical Systems, Inc. |
KAREN A IORIO |
K052611 |
04/26/2006 |
ECP HEALTH SYSTEM, MODEL 2005 |
ECP HEALTH INC. |
SHAMON HUANG |
K060660 |
04/25/2006 |
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER |
EDWARDS LIFESCIENCES, LLC. |
PAULA A TORRIANNI |
K060093 |
04/28/2006 |
PRESEP OLIGON OXIMETRY CATHETERS |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
K060845 |
04/25/2006 |
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K060231 |
04/13/2006 |
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK |
ELCAM MEDICAL A.C.A.L. |
TALI HAZAN |
K053563 |
04/07/2006 |
HUMAPEN MEMOIR |
ELI LILLY AND COMPANY |
LEEANN CHAMBERS |
K060683 |
04/18/2006 |
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
K060990 |
04/26/2006 |
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
K053078 |
04/27/2006 |
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P |
ERGOLINE GMBH |
HAIKO BELL |
K060317 |
04/28/2006 |
ANTHOGYR CONTRA ANGLES AND HANDPIECES |
EST. ANTHOGYR |
ERIC GENEVE |
K060245 |
04/07/2006 |
HARMONIC SCALPEL BLADES AND SHEARS |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
K060778 |
04/28/2006 |
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
K053386 |
04/21/2006 |
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K060044 |
04/06/2006 |
ACUTE CARE FACE MASK, MODEL RT040 |
FISHER & PAYKEL HEALTHCARE, LTD. |
BRETT WHISTON |
K060390 |
04/27/2006 |
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA |
GALIL MEDICAL LTD. |
JONATHAN S KAHN |
K060195 |
04/24/2006 |
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
K060779 |
04/05/2006 |
ADVANCE VESSEL ANALYSIS II |
GE HEALTHCARE |
LARRY A KROGER |
K053121 |
04/05/2006 |
TRAM MODULE |
GE HEALTHCARE |
JOEL KENT |
K060661 |
04/07/2006 |
MACTRODE 3 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN RUSSELL |
K053356 |
04/19/2006 |
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
RONALD N BLASKI |
K060052 |
04/19/2006 |
GE LIGHTSPEED XTRA CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, LLC |
GLEN E SABIN |
K060222 |
04/28/2006 |
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
DEN060001 |
04/26/2006 |
PHICAL TEST |
GENOVA DIAGNOSTICS |
PATRICK HANAWAY |
K053497 |
04/14/2006 |
GUAVA EZCD4 SYSTEM |
GUAVA TECHNOLOGIES, INC. |
LAWRENCE F BRUDER |
K053459 |
04/12/2006 |
OMNILINK .035 BILIARY STENT SYSTEM |
GUIDANT CORPORATION |
SYLVIA HERNANDEZ |
K052420 |
04/06/2006 |
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
GYNOVA, LLC |
DON GUINAN |
K060864 |
04/28/2006 |
MULTIDIRECTIONAL THREADED PEG |
HAND INNOVATIONS, LLC. |
NATALIE S HECK |
K060635 |
04/28/2006 |
CONSENSUS ACETABULAR SHELL SYSTEM |
HAYES MEDICAL, INC. |
LUKE ROSE |
K060729 |
04/12/2006 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV |
HEALTH & LIFE CO., LTD. |
ALEX KOU |
K060835 |
04/21/2006 |
HL888SF |
HEALTH & LIFE CO., LTD. |
ALEX KOU |
K060843 |
04/20/2006 |
MODIFICATION TO HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH |
K060315 |
04/07/2006 |
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
K060834 |
04/19/2006 |
PROBEAT WITH MGCS |
HITACHI, LTD. |
JONATHAN S KAHN |
K060111 |
04/24/2006 |
IVA (MXA II SOFTWARE OPTION) |
HOLOGIC, INC. |
JEANETTE SCHIER-PUGSLEY |
K060147 |
04/28/2006 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
HONGYE PLASTIC PRODUCTS CO., LTD. |
MICKY LIN |
K060806 |
04/21/2006 |
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 |
HOSPIRA, INC. |
PATRICIA MELERSKI |
K060921 |
04/13/2006 |
S2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
K060798 |
04/12/2006 |
STRYKER PLATING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K060613 |
04/21/2006 |
VARIAX LOCKING PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K052319 |
04/04/2006 |
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 |
IMPEDIMED PTY LTD. |
NEVILLE BERTWISTLE |
K051419 |
04/27/2006 |
INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 |
INDITHERM MEDICAL |
M.W. (ANDY) ANDERSON |
K060688 |
04/13/2006 |
HEMOSIL SYNTHASIL |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K060413 |
04/27/2006 |
INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE |
INTACT MEDICAL CORPORATION |
DAVID JACOBS |
K060014 |
04/03/2006 |
INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS |
INTELIFUSE, INC. |
SHARON ROCKWELL |
K060391 |
04/10/2006 |
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 |
INTUITIVE SURGICAL, INC. |
MICHAEL J HYRAMATEGUI |
K060695 |
04/11/2006 |
IBA PROTON THERAPY SYSTEM - PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
K060757 |
04/19/2006 |
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
DENNIS HONG |
K060168 |
04/24/2006 |
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K060365 |
04/17/2006 |
APEXCAL |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K060618 |
04/12/2006 |
CIDEX ACTIVATED DIALDEHYDE SOLUTION |
JOHNSON & JOHNSON CO. |
JOSEPH M ASCENZI |
K060016 |
04/25/2006 |
THROMCAT THROMBECTOMY CATHETER SYSTEM |
KENSEY NASH CORP. |
JENNIFER J BOSLEY |
K060472 |
04/28/2006 |
PREMISE FLOWABLE |
KERR CORPORATION |
COLLEEN BOSWELL |
K060177 |
04/18/2006 |
KLS MARTIN RIGID FIXATION - STERILE |
KLS MARTIN L.P. |
JENNIFER DAMATO |
K060462 |
04/24/2006 |
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) |
LAB VISION CORP. |
GRACE CHANG |
K050094 |
04/20/2006 |
LADY COMP USA |
LADY COMP USA |
MICHAEL CARTAIN |
K060920 |
04/27/2006 |
VELSCOPE |
LED MEDICAL DIAGNOSTICS INC. |
DAVID C MORGAN |
K060533 |
04/14/2006 |
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM |
LENSTEC, INC. |
LUIS RUIZ |
K050989 |
04/06/2006 |
AWQ-104 |
LHASA OMS, INC. |
MARK W SHEEHAN |
K060706 |
04/28/2006 |
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION |
LIBERTY HEALTHCARE GROUP, INC. |
JOHN C GORMLEY |
K052929 |
04/26/2006 |
PREFTEST PROFESSIONAL SUITE |
LIMESTONE TECHNOLOGIES INC. |
NANCY RUTH |
K050988 |
04/06/2006 |
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
K060260 |
04/10/2006 |
MICROPOWER HAND PIECE HIGH SPEED DRILL |
LINVATEC CORP. |
ELIZABETH PAUL |
K060270 |
04/10/2006 |
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL |
LINVATEC CORP. |
ELIZABETH PAUL |
K053628 |
04/07/2006 |
LIGHTSHEER DUET LASER SYSTEM |
LUMENIS, INC. |
Connie Hoy |
K053568 |
04/17/2006 |
BILISOFT PHOTOTHERAPY SYSTEM |
LUMITEX, INC. |
JEFF WILLIAMS |
K060119 |
04/12/2006 |
MCKINLEY SATURATION CATHETER |
MCKINLEY MEDICAL LLC |
JOHN CHAPPELL |
K060166 |
04/21/2006 |
OHMEGA |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
K. OGINK-SOMHORST |
K060680 |
04/11/2006 |
ATRILAZE SURGICAL ABLATION SYSTEM |
MEDICALCV, INC. |
DENNY STEGER |
K060719 |
04/14/2006 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
EDWARD S CHIN |
K060697 |
04/11/2006 |
TRAVEL PAL (MM-111B) /MEGA MOTION |
MEGA MOTION, INC. |
MARK CALOMINO |
K053354 |
04/13/2006 |
INTERMEZZO PLUS FIXTURE |
MEGAGEN CO., LTD. |
DAE CHANG |
K053353 |
04/19/2006 |
RESCUE IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
DAE CHANG |
K060625 |
04/20/2006 |
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR |
MICRO THERAPEUTICS, INC. |
FLORIN TRUUVERT |
K053265 |
04/28/2006 |
MICRUS GUIDE WIRE, WATUSI 0.014 |
MICRUS ENDOVASCULAR CORPORATION |
MARGARET WEBBER |
K060566 |
04/05/2006 |
MINXRAY, MODELS HFP24 AND HFP40 |
MIKASA X-RAY CO., LTD. |
DANIEL KAMM |
K060646 |
04/21/2006 |
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 |
MONITEX INDUSTRIAL CO., LTD. |
Ke-Min Jen |
K060840 |
04/07/2006 |
SVIEW |
MRI CARDIAC SERVICES, INCORPORATED |
S. SCOTT HUBER |
K060679 |
04/21/2006 |
SURTRAK IMPLANTATION KIT |
NORTH AMERICAN SCIENTIFIC, INC. |
LEIGH SPOTTEN |
K053478 |
04/05/2006 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
NORTHERN IMPLANTS, LLC |
GRETA M HOLS |
K060345 |
04/28/2006 |
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K060432 |
04/04/2006 |
NOVABONE POROUS-BONE GRAFT SCAFFOLD |
NovaBone Products, LLC |
DAVID M GAISSER |
K060225 |
04/12/2006 |
NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K060193 |
04/10/2006 |
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 |
OCEANIC MEDICAL PRODUCTS, INC. |
HOWARD M HOLSTEIN |
K060064 |
04/10/2006 |
STETHOFLUX |
ODVI |
ARMELLE LAPRELLE |
K053306 |
04/19/2006 |
IVIEW |
ONDEMANDSOFT |
IAN P GORDON |
K060577 |
04/28/2006 |
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
K060940 |
04/24/2006 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
K060650 |
04/06/2006 |
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
K060336 |
04/28/2006 |
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
K051798 |
04/07/2006 |
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDERMAN |
K060357 |
04/05/2006 |
TREK S NEBULIZER COMPRESSOR |
PARI INNOVATIVE MANUFACTURERS, INC. |
MICHAEL JUDGE |
K053491 |
04/27/2006 |
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
K060579 |
04/20/2006 |
COMFORT/IO IONTOPHORESIS ELECTRODES |
PEPIN MFG., INC. |
Gary Syring |
K060749 |
04/04/2006 |
XPERCT |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
K060941 |
04/19/2006 |
CAAS MRV VERSION 3.0 |
PIE MEDICAL IMAGING B.V. |
CARL M BEAURLINE |
K061018 |
04/28/2006 |
PLANAR DOME EX LINE MODEL DOME E2C |
PLANAR SYSTEMS, INC. |
CRAIG HARSHMAN |
K060617 |
04/05/2006 |
PTS PANELS HDL CHOLESTEROL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
K053542 |
04/10/2006 |
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM |
PRAXIM SA |
RANDY VEALE |
K060282 |
04/10/2006 |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM |
PRAXIM SA |
RANDY VEALE |
K052243 |
04/12/2006 |
PROACT WITH GEL OR PROACT 1 |
PROACT INC. |
JOSEPH M AZARY |
K060326 |
04/05/2006 |
LASERTX - DIODE LASER & DELIVERY SYSTEM |
PROSURG, INC. |
ASHVIN DESAI |
K053388 |
04/04/2006 |
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION |
PURITAN BENNETT CORP. |
JAMES BONDS |
K052641 |
04/12/2006 |
MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
JASON BLAIN |
K053441 |
04/10/2006 |
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
K051227 |
04/07/2006 |
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 |
RENU MEDICAL, INC. |
GEORGE BIGGINS |
K060105 |
04/07/2006 |
VPAP III ST-A/KIDSTA MASK SYSTEM |
RESMED LTD. |
DAVID D'CRUZ |
K060904 |
04/28/2006 |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL LP |
SUSAN D GOLDSTEIN-FALK |
K060754 |
04/18/2006 |
ELECSYS TSH CALSET W/MODELS 04738551 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K060755 |
04/10/2006 |
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK |
ROCHE DIAGNOSTICS CORP. |
RANDY J JOHNSON |
K060330 |
04/07/2006 |
SEE-IT CARIES DETECTOR |
RONVIG DENTAL MFG. A/S |
ANNETTE RAVN NIELSEN |
K060342 |
04/04/2006 |
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K |
ROSSMAX INTERNATIONAL LTD. |
MARK LIN |
K060780 |
04/06/2006 |
TONOMETER DIATON |
RYAZAN STATE INSTRUMENTS |
BORIS KUN |
K060743 |
04/28/2006 |
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) |
SAFETY SYRINGES, INC. |
THOMAS L HALL |
K060522 |
04/11/2006 |
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
ERIC BANNON |
K060392 |
04/26/2006 |
ASP TITANIUM |
SEDATELEC |
Kevin Walls |
K060873 |
04/14/2006 |
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS |
SENTINELLE MEDICAL, INC. |
CAMERON PIRON |
K060753 |
04/27/2006 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
K052118 |
04/03/2006 |
DOSE VERIFICATION SYSTEM |
SICEL TECHNOLOGIES, INC. |
TAMMY B CARREA |
K060992 |
04/28/2006 |
SYNGO US WORKPLACE |
SIEMENS MEDICAL SOLUTIONS |
SHEILA W PICKERING |
K060879 |
04/19/2006 |
MODEL EC9-4 TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK LYNCH |
K060376 |
04/25/2006 |
SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 |
SIMPLER IMPLANT, INC. |
KAREN BERGMAN |
K060892 |
04/14/2006 |
GALILEOS |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K060782 |
04/12/2006 |
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE |
SMITH & NEPHEW WOUND MANAGEMENT |
TERRY MCMAHON |
K060736 |
04/18/2006 |
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS |
SMITH & NEPHEW, INC. |
DAVID HENSLEY |
K060777 |
04/13/2006 |
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM |
SMITH & NEPHEW, INC. |
KATHLEEN BURNS |
K060626 |
04/11/2006 |
VUMAX |
SONOMED, INC. |
GEORGE MYERS |
K052947 |
04/19/2006 |
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE |
SOURCE PRODUCTION & EQUIPMENT CO., INC. |
JOHN J MUNRO |
K053599 |
04/19/2006 |
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES |
SPACELABS MEDICAL INC. |
AL VAN HOUDT |
K060567 |
04/28/2006 |
SPECTRAGENICS ATS-1 |
SPECTRAGENICS, INC. |
ROBERT E GROVES |
K060025 |
04/18/2006 |
SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K052670 |
04/27/2006 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
RONALD K SMITH |
K060954 |
04/21/2006 |
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 |
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS |
KAREN J MCKELVEY |
K060532 |
04/11/2006 |
HDR 1000 PLUS WELL CHAMBER, MODEL 90008 |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
K060750 |
04/19/2006 |
STRYKER INJECTABLE CEMENT |
STRYKER CMF |
WADE T RUTKOSKIE |
K060802 |
04/07/2006 |
VISUM LED SURGICAL LIGHTING SYSTEM |
STRYKER COMMUNICATIONS CORP. |
LOUIS-PIERRE MARCOUX |
K060085 |
04/27/2006 |
STRYKER SCOPE/INSTRUMENT HOLDER |
Stryker Endoscopy |
CRYSTAL ONG |
K060748 |
04/13/2006 |
MODIFICATION TO XIA 4.5 SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K060410 |
04/10/2006 |
ECHOHEART TRANSVAGINAL DOPPLER PROBE |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
K060445 |
04/13/2006 |
NORIAN CRS BONE CEMENT |
SYNTHES (USA) |
ANGELA SILVESTRI |
K060443 |
04/13/2006 |
NORIAN CRS FAST SET PUTTY |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K060621 |
04/21/2006 |
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- |
TDS HOLDINGS INC. |
CYNTHIA C KNAPP |
K053572 |
04/26/2006 |
C. DIFF QUIK CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
K051927 |
04/06/2006 |
TECHLAB ASCA-CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
K053413 |
04/06/2006 |
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES |
TERUMO EUROPE N.V. |
M.J. AERTS |
K052520 |
04/24/2006 |
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERLIE |
K060190 |
04/04/2006 |
SUPER SHEATH XL INTRODUCER SHEATH |
TOGO MEDIKIT CO., LTD. |
HEIDI M ERICKSON |
K060912 |
04/19/2006 |
MODIFICATION TO: HI-ART SYSTEM |
TOMOTHERAPY INCORPORATED |
KENNETH D BUROKER |
K060438 |
04/18/2006 |
RHS |
TORNIER |
Mireille Lemery |
K060545 |
04/21/2006 |
UNITY HUMERAL PLATE |
TORNIER |
Mireille Lemery |
K053610 |
04/19/2006 |
ABARIS |
TRAXTAL TECHNOLOGIES INC. |
NEIL GLOSSOP |
K053520 |
04/11/2006 |
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 |
TRIPATH IMAGING, INC. |
BRYAN J TUCKER |
K060339 |
04/28/2006 |
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY |
TYCO HEALTHCARE/KENDALL |
BRIDGET GARDNER |
K051651 |
04/14/2006 |
G4, MODEL IGM-0004 |
U. S. DIAGNOSTICS, INC. |
EDWARD LETKO |
K052817 |
04/17/2006 |
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF |
UNIVERSAL MEDICAL TECHNOLOGIES |
GLENN HERSKOWITZ |
K053535 |
04/27/2006 |
VIVAWAVE MICROWAVE ABLATION SYSTEM |
VALLEYLAB |
HERBERT VINSON |
K060507 |
04/07/2006 |
VALPLAST YAMAHACHI TEETH |
VALPLAST INTL. CORP. |
MARY MCNAMARA-CULLINANE |
K060573 |
04/21/2006 |
BURBANK TENACULUM |
VASCULAR CONTROL SYSTEMS, INC |
KATHLEEN ROBERTS |
K060327 |
04/12/2006 |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K060797 |
04/07/2006 |
NAKED |
VERAXIS INT'L INC. |
JULES T MITCHEL |
K060741 |
04/05/2006 |
SWIRLGRAFT VASCULAR ACCESS GRAFT |
VERYAN MEDICAL LIMITED |
SEMITH OKTAY |
K060441 |
04/27/2006 |
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 |
VIDENT |
BARBARA J LEWANDOWSKI |
K060712 |
04/19/2006 |
VITELCARE C-TURTLE PATIENT MONITORING SYSTEM |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
ALLEN IZADPANAH |
K052564 |
04/05/2006 |
VYGON LEADER-FLEX |
VYGON CORP. |
COURTNEY SMITH |
K060356 |
04/18/2006 |
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K060731 |
04/19/2006 |
EVOLVE MODULAR RADIAL HEAD |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K060114 |
04/07/2006 |
VECTRA LASER SYSTEM |
XINTEC CORPORATION, DBA, |
MARILYN M CHOU |
K060638 |
04/06/2006 |
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS |
ZIMMER SPINE, INC |
TIM CRABTREE |
K060370 |
04/28/2006 |
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS |
ZIMMER, INC. |
STEPHEN MCKELVEY |
K060710 |
04/26/2006 |
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |