| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K040890 |
11/02/2004 |
3M TEGADERM SILVER |
3M COMPANY |
AMY E SHORT |
| K043097 |
11/19/2004 |
3VISEON |
3MENSIO MEDICAL IMAGING BV |
CARL ALLETTO |
| K042390 |
11/19/2004 |
ETEST FOR GEMIFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K042752 |
11/10/2004 |
ACCUPACH V |
ACCUTOME ULTRASOUND, INC. |
JEFFREY L WRIGHT |
| K042069 |
11/01/2004 |
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
| K042880 |
11/03/2004 |
JETSTREAM WORKSPACE |
ADAC LABORATORIES |
COLEEN A COLEMAN |
| K042496 |
11/02/2004 |
ADEPT ULTRALITE 532 LASER |
ADEPT MEDICAL CONCEPTS |
JERRY MCFARLAND |
| K041855 |
11/10/2004 |
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S |
AEARO CO. |
ANN PHILLIPS |
| K042227 |
11/19/2004 |
INSTANT-VIEW TROPONIN I TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K041978 |
11/23/2004 |
REPROCESSED DIAMOND BURS |
ALLIANCE MEDICAL CORP. |
ERIC VARTY |
| K043196 |
11/30/2004 |
ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
| K042250 |
11/12/2004 |
SENSATOUCH |
ALUNA MANAGEMENT CO., LTD. |
CHARITY MARTIN |
| K042843 |
11/12/2004 |
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS |
AMBU, INC. |
SANJAY PARIKH |
| K042682 |
11/15/2004 |
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR |
AMBU, INC. |
SANJAY PARIKH |
| K041712 |
11/03/2004 |
'RAPIDTEC 4' TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K030275 |
11/29/2004 |
MB SYSTEM, BIOENERGY LIGHT THERAPY |
AMEST CORP. |
JOHN IEST |
| K042889 |
11/16/2004 |
DYNAMOMETER - MODEL FCE AND MODEL MSC |
AMETEK |
PHILIP LACHANCE |
| K042906 |
11/19/2004 |
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 |
AMPLIFE CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K043025 |
11/19/2004 |
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 |
ANALOGIC CORP. |
DONALD J SHERRATT |
| K042685 |
11/18/2004 |
METRICATH SYSTEM |
ANGIOMETRX INC. |
TIM VERSPAGEN |
| K041766 |
11/26/2004 |
EZY-TRAVEL WRISTBAND |
APOTHECARY PRODUCTS, INC. |
DAVID KRAMER |
| K042443 |
11/24/2004 |
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL |
ARKRAY, INC. |
HELEN LANDICHO |
| K041427 |
11/24/2004 |
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K041356 |
11/04/2004 |
ARTHREX TENODESIS SCREW FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
| K041189 |
11/04/2004 |
ARTHREX TRIMIT FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
| K042690 |
11/13/2004 |
ASCENSION PYROSPHERE (PCS) |
ASCENSION ORTHOPEDICS, INC. |
PETER STRZEPA |
| K042968 |
11/24/2004 |
MCL 30 DERMABLATE ER:YAG LASER SYSTEM |
ASCLEPION LASER TECHNOLOGIES GMBH |
GEORGE CHO |
| K043138 |
11/22/2004 |
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 |
ATOS MEDICAL AB |
EDDY ABERG |
| K042580 |
11/17/2004 |
TIDI BRAND STERILIZATION WRAP |
BANTA HEALTHCARE GROUP, LTD. |
INA GORDON |
| K042942 |
11/22/2004 |
MGP 15 DICOM THEATER |
BARCO NV BARCOVIEW |
FRANK FURGUSON |
| K042660 |
11/19/2004 |
NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
| K042661 |
11/19/2004 |
NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FURGUSON |
| K042662 |
11/22/2004 |
NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
| K041172 |
11/18/2004 |
BASBA E-MACHINE |
BASBA INC. |
M. JOYCE HEINRICH |
| K040985 |
11/30/2004 |
PUMP CONNECTIVITY INTERFACE |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
| K042936 |
11/26/2004 |
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K042459 |
11/17/2004 |
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT |
BECKMAN COULTER, INC. |
KIM WALKER |
| K042291 |
11/12/2004 |
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS |
BECKMAN COULTER, INC. |
MARY BETH TANG |
| K042812 |
11/22/2004 |
BBLCHROMAGAR MRSA |
BECTON DICKINSON & CO. |
DENNIS R MERTZ |
| K042491 |
11/22/2004 |
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER |
BECTON DICKINSON & CO. |
LESLIE WOOD |
| K042400 |
11/24/2004 |
MUCOTROL CONCENTRATED ORAL GEL WAFER |
BELCHER PHARMACEUTICALS, INC. |
KOTHA SEKHARAM |
| K042586 |
11/03/2004 |
BEST BREAST BRACHYTHERAPY APPLICATOR |
BEST MEDICAL INTERNATIONAL, INC. |
JOSEPH C WANG |
| K042786 |
11/18/2004 |
BEST MODEL # 81-01 SERIES IR-192 SOURCES |
BEST MEDICAL INTERNATIONAL, INC. |
JOSEPH C WANG |
| K031568 |
11/23/2004 |
BICONITE SURFACE TREATMENT |
BICON, INC. |
VINCENT J MORGAN |
| K042637 |
11/15/2004 |
THE 5.0 X 6.0MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
| K042837 |
11/02/2004 |
LIQUICHEK ELEVATED CRP CONTROL |
BIO-RAD |
ELIZABETH PLATT |
| K042836 |
11/05/2004 |
LIQUICHEK RETICULOCYTE CONTROL (A) |
BIO-RAD |
ELIZABETH PLATT |
| K042865 |
11/24/2004 |
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) |
BIO-RAD |
SUZANNE S PARSONS |
| K042815 |
11/05/2004 |
QUEST TUMOR MARKER CONTROL, MODEL 955 |
BIO-RAD |
ELIZABETH PLATT |
| K042446 |
11/02/2004 |
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS |
BIO-RAD LABORATORIES, INC. |
MARIA ZEBALLOS |
| K042231 |
11/12/2004 |
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
JOHN GREENBAUM |
| K041432 |
11/30/2004 |
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT |
BIOFILM, INC. |
ROBERT L DE ARMOND |
| K042314 |
11/22/2004 |
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE |
BIOGEN |
VICTOR J GANGI |
| K041388 |
11/23/2004 |
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 |
BIOMEDICAL LIFE SYSTEMS, INC. |
GARY BUSSETT |
| K042093 |
11/01/2004 |
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS |
BIOMET, INC. |
TAACY BICKEL JOHNSON |
| K042029 |
11/09/2004 |
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K041595 |
11/12/2004 |
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 |
BIOPRO, INC. |
DAVID MARK |
| K042890 |
11/29/2004 |
TRIAGE D-DIMER TEST, MODEL 98100 |
BIOSITE INCORPORATED |
JEFFERY R DAHLEN |
| K042083 |
11/16/2004 |
MODIFICATION TO VISITOME 20-10 MICROKERATOME |
BIOVISION AG |
DALE SADLIK |
| K042134 |
11/01/2004 |
VERSATILE 1 WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
RICHARD WESTON |
| K042882 |
11/09/2004 |
ENTERYX INJECTION CATHETER |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K041818 |
11/10/2004 |
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
| K041464 |
11/05/2004 |
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K042949 |
11/09/2004 |
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) |
C.R. BARD, INC. |
JOHN C KNORPP |
| K041088 |
11/01/2004 |
TRIFUSION, MODEL 0609190/0659350 |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K042350 |
11/03/2004 |
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
| K041242 |
11/22/2004 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE CALZETTA PATROVIC |
| K041392 |
11/08/2004 |
SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K042615 |
11/05/2004 |
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K043096 |
11/24/2004 |
COMMANDER II |
CARDIOCOM |
CONSTANCE G BUNDY |
| K042806 |
11/24/2004 |
QUADRANT UNIT-1-BOND |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K042144 |
11/12/2004 |
NICOM |
CHEETAH MEDICAL INC. |
BENNY ARAZY |
| K042176 |
11/03/2004 |
AQUIFY LENS COMFORT DROPS |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K042039 |
11/17/2004 |
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
| K042796 |
11/05/2004 |
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE |
COAPT SYSTEMS, INC. |
BANKIM MEHTA |
| K042473 |
11/19/2004 |
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM |
COBE CARDIOVASCULAR, INC. |
JACK ELLISON |
| K042746 |
11/22/2004 |
PET-DOSE |
COMECER S.R.L. |
E.J. Smith |
| K042611 |
11/12/2004 |
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE |
COOK, INC. |
EARL KNIGHT |
| K042824 |
11/16/2004 |
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
BONNIE J TSYMBAL |
| K042969 |
11/08/2004 |
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
DONNA MARSHALL |
| K042680 |
11/19/2004 |
RHIGENE HEP-ANA TEST SYSTEM |
CORGENIX, INC. |
YUSUKE KOBE |
| K042230 |
11/05/2004 |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
CRYOVASCULAR SYSTEMS, INC. |
KIM TOMPKINS |
| K041080 |
11/30/2004 |
SURGICAL DRAPE KIT - D.I.R.R.A. SRL |
D.I.R.R.A. S.R.L. |
ELISABETTA BACCHI |
| K042347 |
11/19/2004 |
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K041680 |
11/10/2004 |
ORAJEL ADVANCED TOOTH DESENSITIZER |
DEL PHARMACEUTICALS, INC. |
MARLENE TIETJEN |
| K042196 |
11/01/2004 |
SAVEDENT BLUE |
DENFOTEX LIGHT SYSTEMS LTD |
JOHN COLLES |
| K042153 |
11/08/2004 |
SOUTH BEACH SMILE LIGHT WHITENING SYSTEM |
DENTOVATIONS, INC. |
M. JOYCE HEINRICH |
| K042905 |
11/04/2004 |
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY |
DENTSPLY INTL. |
HELEN LEWIS |
| K041075 |
11/09/2004 |
FASTIN RC ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KAREN SYLVIA |
| K041069 |
11/09/2004 |
SPIRALOK ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KAREN SYLVIA |
| K042544 |
11/23/2004 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K041928 |
11/23/2004 |
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K041926 |
11/23/2004 |
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K041927 |
11/23/2004 |
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
| K042607 |
11/26/2004 |
PRIMUS US |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K042197 |
11/15/2004 |
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K042704 |
11/26/2004 |
REUSABLE FINGER CLIP SPO2 SENSORS |
ELEKON INDUSTRIES U.S.A., INC. |
KRISTA OAKES |
| K040354 |
11/04/2004 |
METAL/METAL HIP SYSTEM |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
| K042918 |
11/22/2004 |
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 |
ENDO OPTIKS, INC. |
KEITH HERTZ |
| K041708 |
11/30/2004 |
ENPATH SAFETY INTRODUCER |
ENPATH MEDICAL INCORPORATED |
KARYL HASKELL |
| K042700 |
11/08/2004 |
IMAGE MEDICAL ACQUISITION STATION (IMAS) |
ERAD IMAGEMEDICAL CORP. |
GARY J ALLSEBROOK |
| K042897 |
11/19/2004 |
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
| K042753 |
11/08/2004 |
MAMMOTOME MR BIOPSY SYSTEM |
ETHICON ENDO-SURGERY, INC. |
CAROL J SPRINKLE |
| K042842 |
11/09/2004 |
NOVATION 12/14 PRESS-FIT FEMORAL STEM |
EXACTECH, INC. |
Lisa Simpson |
| K041869 |
11/18/2004 |
SELF RETAINING BICANALICULUS INTUBATION SET |
FCI OPHTHALMICS, INC. |
LOUIS ARMAND |
| K041470 |
11/22/2004 |
MORTON IUI CATHETERS |
FERTILITY TECHNOLOGY RESOURCES, INC. |
CONSTANCE W STURGEON |
| K042035 |
11/17/2004 |
ALUMINA HEAD |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K041903 |
11/10/2004 |
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 |
FUJINON, INC. |
JOSEPH M AZARY |
| K042076 |
11/18/2004 |
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 |
FUJINON, INC. |
JOSEPH M AZARY |
| K042043 |
11/24/2004 |
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 |
FUJINON, INC. |
JOSEPH M AZARY |
| K042731 |
11/19/2004 |
ARCHITECT CA 125 II ASSAY |
FUJIREBIO DIAGNOSTICS, INC. |
KIMBERLY PETERSON |
| K040301 |
11/01/2004 |
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K042348 |
11/18/2004 |
GRADIA DIRECT LOFLO |
GC AMERICA, INC. |
TERRY JORITZ |
| K042866 |
11/02/2004 |
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS |
GE HEALTHCARE TECHNOLOGIES |
D. DUERSTELER |
| K042694 |
11/18/2004 |
ADVANCED LUNG ANALYSIS II |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K042642 |
11/03/2004 |
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ANDREW KLUESSENDORF |
| K042844 |
11/03/2004 |
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K042559 |
11/17/2004 |
GEM-TWIN TENS/ MODELS GM3XY/Z |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K042748 |
11/12/2004 |
GENEMAX POWER WHEELCHAIR, PW3 |
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. |
Ke-Min Jen |
| K042749 |
11/12/2004 |
GENEMAX POWER WHEELCHAIR, PW4 |
GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. |
Ke-Min Jen |
| K043112 |
11/24/2004 |
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
| K041239 |
11/08/2004 |
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 |
GENESIS MEDICAL TECHNOLOGY, INC. |
THOMAS KROENKE |
| K041968 |
11/03/2004 |
GENICON BIPOLAR FORCEPS MODEL # 600-005-005 |
GENICON |
GARY HABERLAND |
| K041967 |
11/12/2004 |
GENICON SUCTION IRRIGATION SYSTEM |
GENICON |
GARY HABERLAND |
| K042960 |
11/24/2004 |
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO |
GIVEN IMAGING LTD. |
SHOSH FRIEDMAN |
| K042953 |
11/22/2004 |
MODIFICATION TO PROTEX STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K042830 |
11/17/2004 |
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K041501 |
11/30/2004 |
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS |
GUANGZHOU FORTUNIQUE LTD. |
JANE B CAMPBELL |
| K042908 |
11/12/2004 |
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM |
GUIDANT CORP. |
VIRGINIA SINGER |
| K040660 |
11/15/2004 |
STERICHEK GLUTARALDEHYDE REAGENT STRIPS |
HACH COMPANY |
DAVID A MORRIS |
| DEN040009 |
11/04/2004 |
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) |
HAMILTON THORNE BIOSCIENCES |
DIARMAID DOUGLAS-HAMILTON |
| K042853 |
11/10/2004 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K042980 |
11/17/2004 |
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE |
HOSPIRA, INC. |
PATRICIA MELERSKI |
| K042883 |
11/23/2004 |
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
| K041170 |
11/09/2004 |
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K032315 |
11/18/2004 |
IOP8 INTRA OPERATIVE PROBE |
HUNTLEIGH HEALTHCARE, INC. |
B.J. COLLEYPRIEST |
| K041007 |
11/15/2004 |
MILLENIUM, MODELS 2000, 2001 AND 2002 |
HYPERBARIC FOR LIFE LLC |
RICK RYDER |
| K042697 |
11/19/2004 |
SECOND LOOK VIEWER |
ICAD INC. |
JOHN ROSENSTENGEL |
| K042894 |
11/19/2004 |
IMALUX NIRIS IMAGING SYSTEM |
IMALUX CORPORATION |
STEPHANIE HARRINGTON |
| K041817 |
11/19/2004 |
WEST NILE DETECT IGM ELISA |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
| K042557 |
11/08/2004 |
INNOJECT AUTO-INJECTOR |
INNOJECT, INC |
JONATHAN S KAHAN |
| K042798 |
11/04/2004 |
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
| K042855 |
11/12/2004 |
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K042538 |
11/08/2004 |
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX |
INVATEC INNOVATIVE TECHNOLOGIES |
MIKE WINEGAR |
| K042537 |
11/08/2004 |
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX |
INVATEC INNOVATIVE TECHNOLOGIES |
MIKE WINEGAR |
| K042775 |
11/04/2004 |
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
BONNIE BISHOP |
| K042848 |
11/22/2004 |
FRC POSTEC PLUS |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K042819 |
11/09/2004 |
TETRIC EVOCERAM |
IVOCLAR VIVADENT, INC. |
DONNA HARTNETT |
| K042900 |
11/05/2004 |
K.E.P. CONNECTOR AND CLIP |
K.E.P., LLC |
ROSINA ROBINSON |
| K042340 |
11/24/2004 |
KASIOS TCP |
KASIOS BIOMATERIALS |
LAETITA BERNARD |
| K042872 |
11/23/2004 |
RONDOFLEX PLUS 360 |
KAVO AMERICA CORPORATION |
DANIEL KAMM |
| K042572 |
11/05/2004 |
KENDALL CO2NFIRM NOW CO2 DETECTOR |
KENDALL |
BRIDGET GARDNER |
| K042888 |
11/10/2004 |
DEMETRON IDS CURING LIGHT |
KERR CORP. |
COLLEEN BOSWELL |
| K042133 |
11/24/2004 |
DRY LASER IMAGER, MODEL DRYPRO MODEL 793 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K042913 |
11/26/2004 |
CLEARFIL TRI-S BOND |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
| K042618 |
11/26/2004 |
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K041747 |
11/24/2004 |
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) |
LIFEPOINT,INC |
DAVID B GOLDBERG |
| K041746 |
11/23/2004 |
IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) |
LIFEPOINT,INC |
DAVID B GOLDBERG, PH.D. |
| K042966 |
11/19/2004 |
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H |
LINVATEC BIOMATERIALS, LTD. |
TUIJA ANNALA |
| K042778 |
11/04/2004 |
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE |
LINVATEC CORP. |
ELIZABETH PAUL |
| K042744 |
11/30/2004 |
OPTIV ANTAGE DH POWER INJECTION SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
ELLIS ROGERS |
| K042228 |
11/08/2004 |
BEELINE MOTIV, PROPOLIS, PCA |
MCKINLEY, INC. |
MICHELLE PRATTE |
| K042382 |
11/30/2004 |
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD |
MED-GENERAL TECHNOLOGIES LLC |
PAUL MCCREIGHT |
| K040328 |
11/24/2004 |
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER |
MEDCOMP |
ROSANNA SEVERINI |
| K042527 |
11/08/2004 |
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 |
MEDICAL ACTION INDUSTRIES, INC. |
ROBIN BLANKENBAKER |
| K042717 |
11/05/2004 |
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
MARY THORSNESS |
| K042359 |
11/17/2004 |
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL |
MEDICAL DESIGNS, LLC |
PAUL JOHN AXT |
| K040744 |
11/30/2004 |
ATRILAZE SOFT TISSUE ABLATION SYSTEM |
MEDICALCV, INC. |
DENNY STEGER |
| K041284 |
11/22/2004 |
MEDICULT IVM SYSTEM |
MEDICULT A/S |
RONALD G LEONARDI |
| K030901 |
11/26/2004 |
MEDTRADE PRODICT'S SOOTHING GEL PATCH |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K042790 |
11/04/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K042886 |
11/18/2004 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K042210 |
11/04/2004 |
MSD SILO SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K042922 |
11/19/2004 |
VENTURE ANTERIOR CERVICAL PLATING SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K042859 |
11/24/2004 |
KOBRA GPS FIXATION SYSTEM |
MEDTRONIC VERTELINK, INC. |
ALBERT REGO |
| K042851 |
11/09/2004 |
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT |
MENTOR CORP. |
DONNA CRAWFORD |
| K042769 |
11/24/2004 |
ADSEAL ROOT CANAL SEALER |
META BIOMED CO., LTD. |
JENNY SHON |
| K042171 |
11/10/2004 |
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 |
MICRO-MEGA SOCIETE ANONYME |
PHILIPPE GARCIA |
| K041852 |
11/15/2004 |
MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K033095 |
11/17/2004 |
SMOKE EVACUATION ATTACHEMENT |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DAVID LOU |
| K041632 |
11/17/2004 |
MINIMESH POLYPROPYLENE MESH |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K042353 |
11/24/2004 |
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS |
NATIONAL DISPLAY SYSTEMS |
RON HANSEN |
| K042339 |
11/02/2004 |
NEOPLANT IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
DAE KYU CHANG |
| K041323 |
11/17/2004 |
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K041861 |
11/26/2004 |
NEXUS INTRAVENOUS TUBING SETS (NIVTS) |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
| K043042 |
11/18/2004 |
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
NOBEL BIOCARE AB |
ELIZABETH J MASON |
| K042434 |
11/03/2004 |
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 |
NOUVAG AG |
ERICH FORSTER |
| K042089 |
11/24/2004 |
NX STAGE WATER PURIFICATION SYSTEM |
NX STAGE MEDICAL INC |
NORMA LEMAY |
| K043018 |
11/10/2004 |
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 |
OMRON HEALTHCARE, INC. |
LARRY LEPLEY |
| K041983 |
11/17/2004 |
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 |
OPTICON MEDICAL |
GLENN D BRUNNER |
| K042914 |
11/12/2004 |
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
| K042809 |
11/02/2004 |
CUFFPATCH |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
| K042665 |
11/23/2004 |
SMART BITEBLOC |
ORIDION MEDICAL 1987 LTD. |
SANDY BROWN |
| K042625 |
11/18/2004 |
QUIKREAD CRP CALIBRATOR SET |
ORION DIAGNOSTICA OY |
ANNIKHA RANTAMA |
| K042643 |
11/18/2004 |
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K042521 |
11/18/2004 |
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K042520 |
11/30/2004 |
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
| K042475 |
11/10/2004 |
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC |
Ortho-Clinical Diagnostics, Inc. |
MARLENE HANNA |
| K042477 |
11/19/2004 |
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K042816 |
11/10/2004 |
TRAUMACAD 1.2 |
ORTHOCRAT, LTD. |
ADI ICKOWICZ |
| K042766 |
11/16/2004 |
ORTHOFIX VOLAR DISTAL RADIAL PLATE |
ORTHOFIX, INC. |
NICOLLE L FERRIS |
| K041443 |
11/16/2004 |
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K042653 |
11/26/2004 |
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP |
PACK & PROPER CO., LTD. |
JEN KE-MIN |
| K042950 |
11/30/2004 |
VAG O SPECULUM, MODELS VS1, VM1, VL1 |
PANATREX, INC. |
KEVIN KUO |
| K040912 |
11/16/2004 |
HYDROGEL CANALICULAR PLUG |
PARTNERS IN BIOMATERIALS, INC. |
JAMES CHRISTENSEN |
| K042877 |
11/16/2004 |
MICROVERTER URETERAL ACCESS SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON |
| K042867 |
11/02/2004 |
PHILIPS ORTHOPAEDIC APPLICATIONS |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN T HARMER |
| K042935 |
11/09/2004 |
GEMINI GXL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
RAE ANN FARROW |
| K042845 |
11/12/2004 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
EGON PFEIL |
| K042881 |
11/18/2004 |
PMD-2000 INTERFERENTIAL STIMULATOR |
PHOENIX MEDICAL DEVICES, LLC |
JIM KLETT |
| K042671 |
11/19/2004 |
PLANMED SOPHIE NUANCE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
| K041882 |
11/23/2004 |
FLOWCARE SYSTEM |
POINTCARE TECHNOLOGIES INC. |
CYNTHIA A SINCLAIR |
| K042811 |
11/08/2004 |
VIVOSORB SHEET, MODEL FS01 |
Polyganics BV |
JAN NIEUWENHUIS |
| K042874 |
11/05/2004 |
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| K040708 |
11/22/2004 |
STATUS FIRST STREP A |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K042645 |
11/26/2004 |
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
| K042919 |
11/29/2004 |
FIBROTEK FIB |
R2 DIAGNOSTICS, INC. |
PEGGY S CARTER |
| K041143 |
11/05/2004 |
RANDOX BARBITURATE ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K041142 |
11/23/2004 |
RANDOX CANNABINOIDS ASSSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K041144 |
11/03/2004 |
RANDOX OPIATES ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K041951 |
11/15/2004 |
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B |
REMEL INC |
MARY ANN SILVIUS |
| K041937 |
11/16/2004 |
RESTITU |
RESONANT MEDICAL, INC. |
SEAN M CURRY |
| K042601 |
11/19/2004 |
CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX, INC. |
KEVIN MADER |
| K043175 |
11/24/2004 |
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K043095 |
11/23/2004 |
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K042264 |
11/24/2004 |
GUIDEWIRES |
ROCKET MEDICAL PLC |
T. CHARLTON |
| K042773 |
11/23/2004 |
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
| K042614 |
11/22/2004 |
S&C-SELF ETCH PR-BOND |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K040021 |
11/02/2004 |
SHUNTCHECK (PROMETHEUS 1) |
SAMUEL NEFF M.D. |
SAMUEL NEFF |
| K042964 |
11/22/2004 |
MX MONOAXIAL PEDICLE SCREW |
SCIENT'X |
J.D. WEBB |
| K043002 |
11/18/2004 |
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR |
SEDECAL S.A. |
DANIEL KAMM |
| K042876 |
11/18/2004 |
URS LP DIGITAL, MILLENNIUM, RADPRO |
SEDECAL S.A. |
DANIEL KAMM |
| K042307 |
11/03/2004 |
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) |
SERADYN INC. |
JACK ROGERS |
| K042119 |
11/03/2004 |
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHEN YUHONG |
| K042120 |
11/04/2004 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., |
CHEN YUHONG |
| K042617 |
11/05/2004 |
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
NEALIE HARTMAN |
| K043016 |
11/16/2004 |
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
| K042995 |
11/24/2004 |
X-LEONARDO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ANA LADINO |
| K042718 |
11/12/2004 |
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA |
SIEMENS MEDICAL SOLUTIONS, INC. |
NEALIE HARTMAN |
| K043082 |
11/23/2004 |
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
| K034005 |
11/18/2004 |
SDS-4I |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE CHIANG |
| K042127 |
11/19/2004 |
SMITH & NEPHEW MODULAR HIP |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
| K043052 |
11/24/2004 |
TRIGEN HINDFOOT FUSION NAIL |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
| K042619 |
11/05/2004 |
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT |
SONOTECH, INC. |
MARGARET J LARSON |
| K040684 |
11/05/2004 |
T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 |
SPECTROS CORPORATION |
DAVID A BENARON |
| K042640 |
11/23/2004 |
UNI-THREAD SPINAL SYSTEM |
SPINEVISION, INC. |
LYNNETTE WHITAKER |
| K042733 |
11/15/2004 |
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K042909 |
11/12/2004 |
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K042438 |
11/08/2004 |
SUPERDIMENSION/BRONCHUS |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
| K042211 |
11/08/2004 |
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS |
SURGICAL LASER TECHNOLOGIES, INC. |
BOB ROSE |
| K042555 |
11/09/2004 |
SURGICHIP TAG SURGICAL MARKER |
SURGICHIP, INC. |
BRUCE WAXMAN |
| K043008 |
11/17/2004 |
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM |
SURGRX, INC. |
LINDA OLESON |
| K042422 |
11/15/2004 |
D3 CHROMA |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K041959 |
11/08/2004 |
POLARIS DS/COMET |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K042986 |
11/17/2004 |
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K042987 |
11/23/2004 |
MODIFICATION TO SYNTHES CRANIAL PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K042365 |
11/18/2004 |
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K042895 |
11/16/2004 |
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K042652 |
11/04/2004 |
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR |
TAIWAN KING STRONG CO., LTD. |
KE-MEN JEN |
| K042152 |
11/22/2004 |
BINDING SITE IGG SUBLCASS OLYMPUS KITS |
THE BINDING SITE |
JAY H GELLER |
| K041891 |
11/05/2004 |
MININEPH HUMAN RHEUMATOID FACTOR KIT |
THE BINDING SITE |
JAY H GELLER |
| K042739 |
11/03/2004 |
HI-ART SYSTEM |
TOMOTHERAPY INCORPORATED |
KENNETH D BUROKER |
| K041367 |
11/05/2004 |
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
DONALD H WINFIELD |
| K043078 |
11/17/2004 |
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K043111 |
11/18/2004 |
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K033146 |
11/23/2004 |
TONO-PEN TONOMETER TIP COVER |
TRA & ACCESSORIES |
RICHARD MASTROLEO |
| K043012 |
11/17/2004 |
OMNIPULSE MINI, MODEL 2120 |
TRIMEDYNE, INC. |
GLENN YEIK |
| K033033 |
11/22/2004 |
VIZILITE-BLUE ORAL EXAM KIT |
TRYLON CORP. |
MARTIN L LONKY |
| K042256 |
11/17/2004 |
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE |
USA LASER BIOTECH INC. |
M. JOYCE HEINRICH |
| K042216 |
11/12/2004 |
COOL-TIP RF ABLATION SYSTEM |
VALLEYLAB |
CHARLES COPPERBERG |
| K042566 |
11/08/2004 |
VASC-ALERT |
VASC-ALERT, INC. |
JOHN B KENNEDY |
| K042910 |
11/22/2004 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
VELOCIMED INC. |
JOHN CARLINE |
| K042468 |
11/17/2004 |
IVENT 201 PORTABLE VENTILATOR |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K042670 |
11/01/2004 |
FUTURABOND NR |
VOCO GMBH |
GERALD W SHIPPS |
| K042996 |
11/24/2004 |
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE |
VOLCANO THERAPEUTICS, INC. |
LORRY HUFFMAN |
| K042188 |
11/10/2004 |
VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM |
VOLCANO THERAPEUTICS, INC. |
JAMES FARNWORTH |
| K042549 |
11/08/2004 |
MULTI CHEM CAL B |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K042551 |
11/16/2004 |
MULTI-CHEM CALIBRATOR A |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K042550 |
11/08/2004 |
MULTI-LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K042516 |
11/08/2004 |
OTOMIMIX |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K042948 |
11/03/2004 |
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM |
WANDONG MEDICAL |
WANG WEIMIN |
| K031402 |
11/22/2004 |
PERFECTA FEMORAL STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K042466 |
11/24/2004 |
X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE |
ZEST ANCHORS, INC. |
PAUL ZUEST |
| K042702 |
11/23/2004 |
SILHOUETTE SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
TIM CRABTREE |
| K043061 |
11/23/2004 |
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K042776 |
11/04/2004 |
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX |
ZIMMER, INC. |
KAREN CAIN |
| K042761 |
11/17/2004 |
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES |
ZIMMER, INC. |
NOAH BARTSCH |
| K042337 |
11/04/2004 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING |
ZIMMER, INC. |
DALENE BINKLEY |
