| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K052825 |
10/05/2005 |
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K052918 |
10/19/2005 |
REPROCESSED EXTERNAL FIXATION DEVICES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K052944 |
10/20/2005 |
AMBU WHITE SENSOR CFM, CFL |
AMBU A/S |
SANJAY PARIKH |
| K052901 |
10/27/2005 |
ARTHREX TENSIONLOK |
ARTHREX, INC. |
ANN WATERHOUSE |
| K052776 |
10/03/2005 |
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD |
ARTHREX, INC. |
SALLY FOUST |
| K052830 |
10/07/2005 |
SPORTMESH |
ARTIMPLANT AB |
TERRY SHERIDAN POWELL |
| K052981 |
10/24/2005 |
BIS EEG MONITOR, MODEL BISX4 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K052893 |
10/14/2005 |
ATRICURE TRANSPOLAR SYSTEM |
ATRICURE, INC. |
ELSA CHI ABRUZZO |
| K052698 |
10/12/2005 |
MODIFICATION TO: AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
MICHAEL A DOUGLAS |
| K052845 |
10/18/2005 |
B-CARE POWDERED LATEX EXAMINATION GLOVES |
B-CARE INDUSTRIES CO., LTD. |
KEVIN WALLS |
| K052773 |
10/03/2005 |
B. BRAUN 0.2 MICRON FILTER |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K052764 |
10/03/2005 |
DIACAP ULTRA DIALYSIS FLUID FILTER |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCOTT J PEASE |
| K052958 |
10/21/2005 |
COLOR NIO 2MP, E-2320 C |
BARCOVIEW |
LIEVEN DE WANDEL |
| K052772 |
10/03/2005 |
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K052892 |
10/18/2005 |
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K052973 |
10/24/2005 |
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K |
BAXTER HEALTHCARE CORP. |
JOHN MANARIK |
| K053020 |
10/28/2005 |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K052905 |
10/14/2005 |
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K052876 |
10/12/2005 |
TELITHROMYCIN 15UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
DAINELLE CLARK |
| K052853 |
10/11/2005 |
TIGECYCLINE 15UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
DAINELLE CLARK |
| K053011 |
10/26/2005 |
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 |
BIO PROTECH, INC. |
E.J. SMITH |
| K052969 |
10/21/2005 |
SLENDERTONE GYMBODY, MODEL 512-01 |
BIO-MEDICAL RESEARCH, LTD. |
MICHAEL O'SULLIVAN |
| K052838 |
10/07/2005 |
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 |
BIO-RAD |
MARIA ZEBALLOS |
| K053012 |
10/26/2005 |
FIDIS VASCULITIS, MODEL MX007 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
CHRISTELLE COURIVAUD |
| K053004 |
10/28/2005 |
MSAS-VANTAGE |
BIOMERIDIAN, INT. |
GENE SWIFT |
| K052888 |
10/13/2005 |
POROUS TITANIUM ACETABULAR AUGMENTS |
BIOMET MANUFACTURING CORP. |
ALLISON KOSKEY |
| K052996 |
10/25/2005 |
POROUS TITANIUM ACETABULAR SHELLS |
BIOMET MANUFACTURING CORP. |
ALLISON KOSKEY |
| K052990 |
10/24/2005 |
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM |
BIOMET, INC. |
LESTER F PADILLA |
| K052789 |
10/31/2005 |
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 |
BIOSITE INCORPORATED |
RACHAEL S WILLIAMSON |
| K052799 |
10/03/2005 |
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K052964 |
10/21/2005 |
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN |
BOSTON SCIENTIFIC CORP. |
KATIE GERBENSKY |
| K052783 |
10/03/2005 |
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX |
BOSTON SCIENTIFIC CORP. |
DIANE BRINZA |
| K052966 |
10/21/2005 |
CI KNEE, CI MI TKR |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K052779 |
10/03/2005 |
BRECOMP |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052781 |
10/03/2005 |
BREFORMANCE |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052780 |
10/03/2005 |
DENTAPLAST HOT, MODEL 16-XXX |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052898 |
10/14/2005 |
IQMARK EZ STRESS |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
| K052862 |
10/11/2005 |
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) |
BRYAN KEROPIAN DDS |
BRYAN KEROPIAN |
| K052843 |
10/24/2005 |
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K053031 |
10/27/2005 |
EXTENDSURE HBFASC CONTROL |
CANTEBURY SCIENTIFIC LTD. |
MAURICE OWEN |
| K052595 |
10/03/2005 |
CRC 15ULTRA |
CAPINTEC, INC. |
MARY ANNE DELL |
| K053049 |
10/28/2005 |
ALARIS SAFETY MALE LUER |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K052790 |
10/03/2005 |
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K052963 |
10/21/2005 |
MEDIQ VERSION 1.0 |
CLARIO MEDICAL IMAGING, INC. |
PATRICIA A MILBANK |
| K053014 |
10/26/2005 |
POLY SILOXANE IMPRESSION MATERIAL |
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. |
JEANETTE SMITH |
| K052812 |
10/04/2005 |
OSSIMEND (TM) BONE GRAFT MATERIAL |
COLLAGEN MATRIX, INC. |
PEGGY C HANSEN |
| K053040 |
10/28/2005 |
PARACEM UNIVERSAL DC |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K052820 |
10/04/2005 |
PARAPOST PARACORE AUTOMIX 5ML |
COLTENE/WHALEDENT AG |
H. J. VOGELSTEIN |
| K052992 |
10/25/2005 |
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY |
CONMED LINVATEC |
ELIZABETH PAUL |
| K052841 |
10/07/2005 |
MIRA-FLEX 18 MICROCATHETER |
COOK, INC. |
THALIA BRINE |
| K052834 |
10/07/2005 |
MREYE EMBOLIZATION COIL |
COOK, INC. |
LISA M WEBB |
| K053061 |
10/31/2005 |
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
DADE BEHRING, INC. |
YUK-TING LEWIS |
| K052788 |
10/03/2005 |
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K052883 |
10/13/2005 |
CARDIOSERVER |
DATRIX |
LINDA GLUCKMAN |
| K052957 |
10/21/2005 |
IMPLANTIUM PROSTHETICS |
DENTIUM CO., LTD. |
CATHRYN N CAMBRIA |
| K052823 |
10/04/2005 |
IMPLANTIUM ABUTMENTS |
DENTIUM, INC. |
KLAAS BESSELING |
| K053010 |
10/26/2005 |
VISTADENT AT COMPLETE, MODEL 3.1 |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K052840 |
10/07/2005 |
IGI-SYSTEM |
DENX ADVANCED DENTAL SYSTEMS |
RACHEL WEISSBROD |
| K053002 |
10/27/2005 |
DEPUY CMW 1 GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K053003 |
10/27/2005 |
DEPUY CMW 1, 2 AND 3 BONE CEMENTS |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K052794 |
10/07/2005 |
ETI-MAX 3000 |
DIASORIN, INC. |
CAROL A DEPOUW |
| K052800 |
10/05/2005 |
PROVISIONAL INLAY/ONLAY KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K052743 |
10/03/2005 |
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 |
DYNAREX CORP. |
JAMES HURLMAN |
| K053008 |
10/26/2005 |
E-Z-EM ENDOSCOPIC CO2 REGULATOR |
E-Z-EM, INC. |
ROBERT WILLIAMS |
| K053016 |
10/26/2005 |
WIRELESS PHYSIOLOGIC MONITORING SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
DIANE PETERSON |
| K052777 |
10/03/2005 |
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D |
ELLEX MEDICAL PTY. LTD. |
KEVIN HOWARD |
| K052938 |
10/20/2005 |
CR-PRO |
ERADLINK, INC. |
ALBERT KOUBA |
| K052805 |
10/04/2005 |
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 |
ESAOTE S.P.A. |
CARRI GRAHAM |
| K053056 |
10/31/2005 |
HARMONIC SCALPEL BLADES AND SHEARS |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
| K052953 |
10/20/2005 |
NUVANCE* FACIAL REJUVENATION SYSTEM |
ETHICON, INC. |
JENNIFER M PAINE |
| K052999 |
10/25/2005 |
SEMPERFLO INFUSION SYSTEM |
ETHICON, INC. |
JENNIFER M PAINE |
| K052909 |
10/17/2005 |
EVENFLO ELAN BREAST PUMP |
EVENFLO COMPANY, INC. |
THOMAS A SPARNO |
| K052787 |
10/03/2005 |
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) |
EXACTECH, INC. |
MARITZA ELIAS |
| K052849 |
10/11/2005 |
INFRARED THERMOMETER, FDIR-V1 |
FAMIDOC TECHNOLOGY CO., LTD |
MR. STEELJIN |
| K052813 |
10/04/2005 |
FD TENS 2030, MODEL DFJ24T |
FUJI DYNAMICS LIMITED |
ANTHONY AH YIN SHUN |
| K052889 |
10/13/2005 |
VITROS CA 19-9 |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L WOLANIUK |
| K052995 |
10/25/2005 |
ADVANTAGE WORKSTATION 4.3. |
GE HEALTHCARE |
LARRY A KROGER |
| K052839 |
10/07/2005 |
CT PERFUSION 4 |
GE HEALTHCARE |
LARRY KROGER |
| K052972 |
10/24/2005 |
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
GE HEALTHCARE |
JOEL KENT |
| K052977 |
10/24/2005 |
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
| K052976 |
10/24/2005 |
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
| K052880 |
10/12/2005 |
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT |
GE HEALTHCARE |
JOEL C KENT |
| K052756 |
10/03/2005 |
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM |
GE HEALTHCARE |
JOEL KENT |
| K052755 |
10/03/2005 |
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT |
GE HEALTHCARE |
JOEL KENT |
| K052975 |
10/24/2005 |
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
| K052855 |
10/11/2005 |
STARSPEED SERIES CT SCANNER SYSTEMS |
GE HEALTHCARE |
LEKSHMI NAIR |
| K053009 |
10/26/2005 |
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K052978 |
10/24/2005 |
GE 1.5T SIGNA HDE MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K052897 |
10/14/2005 |
GE DEFINIUM AMX 700, MODEL AMX 700 |
GENERAL ELECTRIC MEDICAL SYSTEMS |
MARK STAUFFER |
| K053041 |
10/31/2005 |
MED SCULPT |
GENERAL PROJECT S.R.L. |
MAUREEN O'CONNELL |
| K052899 |
10/18/2005 |
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC |
GENESEE BIOMEDICAL, INC. |
JOHN T.M. WRIGHT |
| K053055 |
10/31/2005 |
ORTHODONTIC POLYMER COMPOSITE BRACKET |
GESTENCO INTERNATIONAL AB |
GORAN STEEN |
| K052923 |
10/18/2005 |
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES |
GREAT GLOVE (CHINA), INC. |
K.M. LEE |
| K052922 |
10/18/2005 |
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES |
GREAT GLOVE (CHINA), INC. |
K.M. LEE |
| K052956 |
10/21/2005 |
NITRILE BLUE POWDER FREE EXAMINATION GLOVE |
GREAT GLOVE SDN BHD |
LIM WEE-CHAI |
| K052955 |
10/21/2005 |
NITRILE BLUE POWDERED EXAMINATION GLOVES |
GREAT GLOVE SDN BHD |
LIM WEE-CHAI |
| K053019 |
10/26/2005 |
ACUITY STEERABLE STYLET ACCESSORY |
GUIDANT CORPORATION |
JENNIFER X TANG |
| K052965 |
10/21/2005 |
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. |
GUIDANT CORPORATION |
LINDA KLEINSASSER |
| K053000 |
10/25/2005 |
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) |
HAEMONETICS CORP. |
GABRIEL J MURACA |
| K052863 |
10/12/2005 |
RAPHAEL COLOR |
HAMILTON MEDICAL AG |
CURDIN DANUSER |
| K052925 |
10/18/2005 |
SMARTPREP2 CENTRIFUGE SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
JOHN D BONASERA |
| K052891 |
10/13/2005 |
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM |
HAWKEN INDUSTRIES |
GEORGE MYERS |
| K052935 |
10/19/2005 |
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) |
HEIDELBERG ENGINEERING |
GERHARD ZINSER |
| K052828 |
10/05/2005 |
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) |
HOSPIRA, INC. |
THOMAS KOZMA |
| K053038 |
10/27/2005 |
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K052917 |
10/18/2005 |
STRYKER COMPARTMENTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K052811 |
10/04/2005 |
HSINER JET NEBULIZER, MODEL HS-31100 |
HSINER CO., LTD. |
TOM SHANKS |
| K052865 |
10/11/2005 |
HOSPIRA CATH LAB CONVENIENCE KITS |
ICU MEDICAL, INC. |
TOM KOZMA |
| K053046 |
10/28/2005 |
ILUMA ORTHOCAT/DENTALCAT |
IMTEC CORP. |
J. BRAD VANCE |
| K052908 |
10/14/2005 |
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 |
INFRAREDX, INC. |
NANDINI MURTHY |
| K052951 |
10/20/2005 |
ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD HOLSTEIN |
| K053045 |
10/31/2005 |
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
INTEGRA LIFESCIENCES CORPORATION |
DONNA WALLACE |
| K052791 |
10/05/2005 |
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEPHANIE ROBINSON |
| K053017 |
10/26/2005 |
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS |
INVIVO CORPORATION |
THOMAS SCHUBERT |
| K052979 |
10/24/2005 |
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE |
ISOLUX LLC |
NILCOLAOS ANDREOULAKIS |
| K052798 |
10/03/2005 |
CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C |
ISOVAC PRODUCTS LLC |
LISA S JONES |
| K052587 |
10/11/2005 |
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K053030 |
10/27/2005 |
J. MORITA AZ ULTRASONIC SYSTEM |
J. MORITA USA, INC. |
HOWARD ROWE |
| K052870 |
10/13/2005 |
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 |
KIMBERLY-CLARK CORP. |
TIERNEY NORSTED |
| K052824 |
10/05/2005 |
KIMBERLY-CLARK PROCEDURE GOWN |
KIMBERLY-CLARK CORP. |
CHERYL M SANZARE |
| K053026 |
10/27/2005 |
KOWA NONMYD 7, KOWA NONMYD A-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K052980 |
10/24/2005 |
LIBERTY GLUCOSE CONTROL, MODEL 2120031 |
LIBERTY HEALTHCARE GROUP, INC. |
JOJN C GORMLEY |
| K052954 |
10/31/2005 |
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET |
LIFE-TECH, INC. |
JEFF KASOFF |
| K052929 |
10/19/2005 |
PREFTEST PROFESSIONAL SUITE |
LIMESTONE TECHNOLOGIES INC. |
NANCY RUTH |
| K052846 |
10/11/2005 |
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE |
MAANSHAN MEDICAL INSTRUMENTS CO., LTD. |
KEVIN WALLS |
| K052851 |
10/11/2005 |
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K052802 |
10/03/2005 |
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE |
MANAN MEDICAL PRODUCTS, INC. |
NICOHL R WILDING |
| K053025 |
10/27/2005 |
JOSTRA HLM TUBING SET |
MAQUET CARDIOPULMONARY AG |
KATHLEEN JOHNSON |
| K053052 |
10/31/2005 |
MEDELA SWING BREAST PUMP |
MEDELA AG |
WEMER FREI |
| K052911 |
10/17/2005 |
ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
SHIM KYUNG-AM |
| K052833 |
10/07/2005 |
GORE-TEX NON-STERILE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
| K053042 |
10/28/2005 |
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE |
MEDRAD, INC. |
LISA A EWING |
| K052827 |
10/07/2005 |
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS |
MEDRAD, INC. |
LISA A EWING |
| K052797 |
10/18/2005 |
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM |
MEDTEK DEVICES, INC. |
ROBERT O DEAN |
| K052854 |
10/11/2005 |
LIFENET EXCHANGE SYSTEM |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
TERESA DAVIDSON |
| K052860 |
10/12/2005 |
CG FUTURE ANNULOPLASTY BAND |
MEDTRONIC HEART VALVES |
JULIE SHERMAN |
| K052970 |
10/24/2005 |
SIMPLICI-T ANNULOPLASTY SYSTEM |
MEDTRONIC HEART VALVES |
PHIL NEURURER |
| K052931 |
10/19/2005 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052919 |
10/21/2005 |
MICROSULIS TISSUE ABLATION SYSTEM |
MICROSULIS AMERICAS, INC. |
TIMOTHY Y COWART |
| K053018 |
10/26/2005 |
POLY SILOXANE IMPRESSION MATERIAL |
MILLENNIUM DENTAL INTERNATIONAL, INC. |
JEANETTE SMITH |
| K052946 |
10/20/2005 |
MPS ACACIA NERVE BLOCK NEEDLE |
MPS ACACIA |
FERGIE F FERGUSON |
| K052874 |
10/12/2005 |
SOPRANO HAIR REMOVAL DIODE LASER |
MSQ (M2) LTD. |
TATIANA EPSTEIN |
| K052942 |
10/20/2005 |
21.3INCH MONOCHROME LCD MONITOR |
NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. |
SHUICHI KINO |
| K052930 |
10/19/2005 |
NAVIGATOR ENDOSCOPY SYSTEM |
NEOGUIDE SYSTEMS, INC. |
MICHAEL A DANIEL |
| K052878 |
10/14/2005 |
NT-1000 |
NEUROTHERM, INC. |
WILLIAM RITTMAN |
| K052885 |
10/20/2005 |
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
| K052829 |
10/13/2005 |
WRISTOX MODEL 3100 PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI ROTH |
| K052987 |
10/24/2005 |
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC |
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH |
CARL ALLETTO |
| K052804 |
10/04/2005 |
BREATHKEY MODEL G10/BREATHKEY MODEL G30X |
OMEGAPOINT SYSTEMS, LLC |
BARBARA S FANT |
| K053044 |
10/28/2005 |
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 |
OPTO GLOBAL, INC |
MARK T FUKUHARA |
| K052819 |
10/25/2005 |
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
DARLENE J PHILLIPS |
| K052867 |
10/11/2005 |
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
DARLENE J PHILLIPS |
| K052968 |
10/21/2005 |
MODIFICATION TO: ORLUS MINI SCREW |
ORTHOLUTION CO., LTD. |
CATHRYN CAMBRIA |
| K052866 |
10/14/2005 |
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER |
OXYHEAL HEALTH GROUP |
DAVE HEANY |
| K052983 |
10/28/2005 |
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K052793 |
10/03/2005 |
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 |
PHARMACIA DIAGNOSTICS AB |
MARTIN R MANN |
| K052974 |
10/24/2005 |
WARMING LIQUID PERSONAL LUBRICANT |
PHARMAPAC LLC |
TOM OTTO |
| K052961 |
10/21/2005 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN |
PHILIPS MEDICAL SYSTEMS |
TAPAN D SHAH |
| K052801 |
10/03/2005 |
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
| K052795 |
10/03/2005 |
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K052988 |
10/24/2005 |
CAAS |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
| K052910 |
10/17/2005 |
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K052941 |
10/20/2005 |
I-NEB INSIGHT AAD SYSTEM |
PROFILE THERAPEUTICS PLC |
BARBARA CAMPBELL |
| K052903 |
10/14/2005 |
PEDIATRIC FEEDING TUBE |
PROMEDIC, INC. |
PAUL DRYDEN |
| K052858 |
10/12/2005 |
SOOTHIES GEL PADS |
PURONXY, INC. |
LESLIE SEBASTAIN |
| K052900 |
10/14/2005 |
QUILL NONABSORBABLE NYLON BARBED SUTURE |
QUILL MEDICAL, INC. |
LOIS V SMART |
| K052991 |
10/25/2005 |
RADIANCY FACIAL SKINCARE DEVICE |
RADIANCY (ISRAEL) LTD. |
MARGARET FOURTE |
| K052914 |
10/17/2005 |
RX IMOLA |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K053047 |
10/28/2005 |
FRAXEL SR LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K052844 |
10/07/2005 |
KAVS - CATHETER, MODELS 1107100 & 1107060 |
RICHTER & ROTHE AG |
JOACHIM RICHTER |
| K052982 |
10/24/2005 |
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET |
ROCHE DIAGNOSTICS |
RANDY JOHNSON |
| K053059 |
10/31/2005 |
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK |
ROCHE DIAGNOSTICS |
RANDY JOHNSON |
| K053006 |
10/26/2005 |
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II |
ROSSMAX INTERNATIONL LTD. |
YOLANDA LIN |
| K052934 |
10/24/2005 |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
S.O.R. INTERNACIONAL, S.A. |
IAN GORDON |
| K052861 |
10/11/2005 |
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K052809 |
10/04/2005 |
SAUFLON FLAT COLOURED LENS CASE |
SAUFLON PHARMACEUTICALS, LTD. |
AZITTA JADALIZADEH |
| K052832 |
10/06/2005 |
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES |
SAUFLON PHARMACEUTICALS, LTD. |
TANYA FAIR |
| K052920 |
10/17/2005 |
DELTA4 |
SCANDIDOS AB |
THOMAS MATZEN |
| K052810 |
10/05/2005 |
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
ERIC BANNON |
| K052763 |
10/21/2005 |
STELLA CERVICAL PLATE |
SCIENT'X |
J. D. WEBB |
| K052904 |
10/14/2005 |
VIRTUAL MEDICAL SYSTEMS MODEL VT3000 |
SCIENTIFIC IMAGING, INC. |
CHRIS JOHNSON |
| K052857 |
10/11/2005 |
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 |
SENORX, INC. |
AMY BOUCLY |
| K052815 |
10/04/2005 |
QMS AMIKACIN REAGENTS |
SERADYN INC. |
JACK ROGERS |
| K052826 |
10/05/2005 |
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS |
SERADYN INC. |
JACK ROGERS |
| K052890 |
10/13/2005 |
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K053024 |
10/21/2005 |
SYNGO NEURO DSA CT |
SIEMENS AG |
RUEDIGER KOERNER |
| K052775 |
10/03/2005 |
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) |
SIEMENS AG, MEDICAL SOLUTIONS |
SIEGLINDE WEST |
| K052895 |
10/14/2005 |
FOURSIGHT VIEWTOOL IMAGE VIEWER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
| K053007 |
10/27/2005 |
SKYLARK URO PROBE |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE CHIANG |
| K052792 |
10/03/2005 |
ANTHOLOGY HIP STEM |
SMITH & NEPHEW, INC. |
JANET AKIL |
| K052947 |
10/25/2005 |
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE |
SOURCE PRODUCTION & EQUIPMENT CO., INC. |
JOHN J MUNRO |
| K052848 |
10/12/2005 |
SPECTRA HAIR REMOVAL LASER |
SPECTRAGENICS, INC. |
ROBERT E GROVE |
| K052871 |
10/12/2005 |
STRYKER CUSTOM TI IMPLANT |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
| K052971 |
10/24/2005 |
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052875 |
10/12/2005 |
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES |
SUMMIT MANUFACTURING, L.L.C. |
SUSAN D GOLDSTEIN-FALK |
| K052852 |
10/11/2005 |
SUPERDIMENSION/BRONCHUS PREMIUM |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
| K052695 |
10/11/2005 |
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS |
SURETEK MEDICAL |
MIKE SAMMON |
| K052691 |
10/11/2005 |
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES |
SURETEK MEDICAL |
MIKE SAMMON |
| K052692 |
10/11/2005 |
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES |
SURETEK MEDICAL |
MIKE SAMMON |
| K052690 |
10/11/2005 |
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS |
SURETEK MEDICAL |
MIKE SAMMON |
| K052962 |
10/21/2005 |
OPTIMIZED BARB DESIGN |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K052943 |
10/28/2005 |
DDRFORMULA AND DDRFORMULA PLUS |
SWISSRAY MEDICAL AG |
JOHN MONAHAN |
| K052877 |
10/13/2005 |
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
MICKY LIN |
| K053022 |
10/26/2005 |
SYNTHES (USA) CHRONOS-BETA-TCP |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K052872 |
10/11/2005 |
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A |
TAIDOC TECHNOLOGY CORPORATION |
SHU-MEI WU |
| K053028 |
10/27/2005 |
TECHDEVICE GUIDEWIRE |
TECHDEVICE CORPORATION |
LEIGH HAYWARD |
| K052932 |
10/19/2005 |
CRYPTOSPORIDIUM II |
TECHLAB, INC. |
DAVID M LYERLY |
| K052837 |
10/06/2005 |
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA |
TERANG NUSA SDN BHD |
CHIN GUAN LOW |
| K052887 |
10/13/2005 |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K052985 |
10/24/2005 |
POWDER FREE VINYL EXAMINATION GLOVE |
TG MEDICAL (CHINA) INCORPORATION |
WU KIN YEAP |
| K052984 |
10/24/2005 |
POWDERED VINYL EXAMINATION GLOVE |
TG MEDICAL (CHINA) INCORPORATION |
WU KIN YEAP |
| K052778 |
10/03/2005 |
THERMAGE THERMACOOL SKIN MARKETING |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K052936 |
10/19/2005 |
THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K052822 |
10/04/2005 |
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 |
THUNDER TIGER CORP. |
KE MIN JEN |
| K052882 |
10/12/2005 |
FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE |
TIANJIN NEW BAY BIORESEARCH CO., LTD. |
RODRIGO BERLIE |
| K052859 |
10/11/2005 |
AQUAMANTYS PUMP GENERATOR SYSTEM |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
| K053043 |
10/28/2005 |
ENCOMPASS SOFTWARE PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K052884 |
10/13/2005 |
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
MICHAELA MAHL |
| K052864 |
10/11/2005 |
TYRX SURGICAL MESH, MODEL SMPC-0501 |
TYRX PHARMA INC |
MASON W DIAMOND |
| K052818 |
10/04/2005 |
EZ SMART-168 GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
DAVID ROSEN |
| K052817 |
10/19/2005 |
EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF |
UNIVERSAL MEDICAL TECHNOLOGIES |
GLENN HERSKOWITZ |
| K052916 |
10/17/2005 |
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
| K052814 |
10/04/2005 |
LUMINA 1600, 3300 AND 6600 SYSTEMS |
USA LASER BIOTECH INC. |
M. JOYCE HEINRICH |
| K052836 |
10/06/2005 |
BODIHEALTH SYSTEM |
USA LASER THERAPEUTICS, INC. |
M. JOYCE HEINRICH |
| K052796 |
10/03/2005 |
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES |
VALLEYLAB |
ROBERT C MOORE |
| K053051 |
10/28/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
TRISH STEPHENS |
| K052738 |
10/11/2005 |
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 |
VEINRX INC. |
GREGORY J MATHISON |
| K052741 |
10/03/2005 |
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES |
W & H DENTALWERK BUERMOOS GMBH |
GABRIELE WIENBECK |
| K052806 |
10/04/2005 |
BURANE |
WAVELIGHT LASER TECHNOLOGIE AG |
ALEXANDER POPP |
| K052784 |
10/03/2005 |
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 |
WELCH ALLYN, INC. |
CHRIS KLACZKY |
| K053027 |
10/27/2005 |
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) |
WELCH ALLYN, INC. |
JOHN E SAWYER |
| K052785 |
10/05/2005 |
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 |
WELL-LIFE HEALTHCARE LIMITED |
GRACE CHANG |
| K052913 |
10/17/2005 |
IGNITE BONE VOID FILLER KIT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K052915 |
10/17/2005 |
PROFEMUR XTR HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K052847 |
10/07/2005 |
CAPLESS PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
FLOYD G LARSON |
| K052912 |
10/19/2005 |
YUSHENG DISPOSABLE VAGINAL SPECULUM |
ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. |
PEIFANG XING |
| K052997 |
10/25/2005 |
ZIMMER DENTAL ONE-PIECE IMPLANT |
ZIMMER DENTAL INC. |
ERIN MCVEY |
| K052950 |
10/20/2005 |
THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K052879 |
10/12/2005 |
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS |
ZIMMER, INC. |
BRANDON HIPSHER |
| K052906 |
10/14/2005 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
DALENE T BINKLEY |
