| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K052638 |
11/07/2005 |
ABBOTT SPINE, INC. SPINNAKER SYSTEM |
ABBOTT SPINE, INC. |
LISA PETERSON |
| K051925 |
11/29/2005 |
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN |
ACCESS BIO INCORPORATE |
YOUNG HO CHOI |
| K052335 |
11/23/2005 |
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA |
ACCUTRON, INC. |
ROBERT N CLARK |
| K052374 |
11/22/2005 |
RAPID PROGEAMMER 3.0 |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K051492 |
11/14/2005 |
AESKULISA ASCA A |
AESKU.INC |
STANLEY AMMONS |
| K052703 |
11/10/2005 |
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL |
ALDEN OPTICAL LABS., INC. |
CHARLES H CREIGHTON |
| K052603 |
11/16/2005 |
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
| K052414 |
11/16/2005 |
REPROCESSED ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
| K052201 |
11/10/2005 |
SOLANAS POSTERIOR STABILIZATION SYSTEM |
ALPHATEC SPINE, INC. |
ELLEN A YARNALL |
| K052537 |
11/16/2005 |
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 |
AMERICAN MEDICAL SALES, INC. |
CAROL M LIFLAND |
| K052647 |
11/09/2005 |
CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. |
AMERICAN SPINE CENTER, LTD. |
JAMES WHITE |
| K052387 |
11/29/2005 |
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX |
ARTHREX, INC. |
ANN WATERHOUSE |
| K052607 |
11/07/2005 |
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS |
ARTHREX, INC. |
ANN WATERHOUSE |
| K052736 |
11/03/2005 |
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT |
ARTHREX, INC. |
ANN WATERHOUSE |
| K052667 |
11/25/2005 |
ARTSANA PISTON AND INSULIN SYRINGES |
ARTSANA S.P.A. |
LARA N SIMMONS |
| K051561 |
11/02/2005 |
ASAHI ANGIOGRAPHIC CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K052339 |
11/30/2005 |
ASAHI PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K052137 |
11/03/2005 |
ASCENSION MUH |
ASCENSION ORTHOPEDICS, INC. |
GLEN NEALLY |
| K052981 |
11/01/2005 |
BIS EEG MONITOR, MODEL BISX4 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K052698 |
11/08/2005 |
MODIFICATION TO: AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
MICHAEL A DOUGLAS |
| K052075 |
11/09/2005 |
PROCEDUR-10 |
AVANCA MEDICAL DEVICES, INC. |
FRANK FERGUSON |
| K052541 |
11/03/2005 |
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM |
AVANT MEDICAL SYSTEMS |
DANIEL KAMM |
| K052393 |
11/09/2005 |
B. BRAUN MODIFIED BICARBONATE DIALYSATE |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K052252 |
11/16/2005 |
CONTRAST MEDIA TRANSFER SETS |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K052958 |
11/16/2005 |
COLOR NIO 2MP, E-2320 C |
BARCOVIEW |
LIEVEN DE WANDEL |
| K051672 |
11/23/2005 |
POWERPICC |
BARD ACCESS SYSTEMS, INC. |
LYNN M KIRCHOFF |
| K052578 |
11/25/2005 |
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J |
BARD PERIPHERAL VASCULAR, INC. |
GENEVIEVE BALUTOWSKI |
| K052892 |
11/30/2005 |
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K051722 |
11/18/2005 |
TRICOS T |
BAXTER HEALTHCARE CORP. |
BRIAN L BISHOP |
| K053082 |
11/30/2005 |
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K052905 |
11/18/2005 |
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K052876 |
11/14/2005 |
TELITHROMYCIN 15UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
DAINELLE CLARK |
| K052853 |
11/17/2005 |
TIGECYCLINE 15UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
DAINELLE CLARK |
| K052481 |
11/28/2005 |
BD VIPER SYSTEM |
BECTON, DICKINSON & CO. |
COLLEEN A KISTLER |
| K051914 |
11/03/2005 |
GENEROS 80, GENEROS 60 |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K051620 |
11/18/2005 |
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES |
BETTER WATER, INC. |
MICHAEL CLINE |
| K053126 |
11/30/2005 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
Angela Drysdale |
| K052969 |
11/16/2005 |
SLENDERTONE GYMBODY, MODEL 512-01 |
BIO-MEDICAL RESEARCH, LTD. |
MICHAEL O'SULLIVAN |
| K052838 |
11/09/2005 |
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 |
BIO-RAD |
MARIA ZEBALLOS |
| K052656 |
11/07/2005 |
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K052255 |
11/23/2005 |
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS |
BIOMET, INC. |
ALLISON K KOSKEY |
| K052596 |
11/15/2005 |
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 |
BIOPRO, INC. |
DAVID MRAK |
| K052456 |
11/04/2005 |
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
JASPER BENKE |
| K052280 |
11/07/2005 |
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM |
BOSTON SCIENTIFIC CORP. |
DEBBIE MCINTIRE |
| K053128 |
11/30/2005 |
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K052213 |
11/02/2005 |
NAVIGATION SW HIP 3.1 ON CI |
BRAINLAB AG |
RAINER BIRKENBACH |
| K050800 |
11/23/2005 |
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS |
CAESAREA MEDICAL ELECTRONICS LTD. |
GALI TZURY |
| K052218 |
11/23/2005 |
CRONO FIVE AND CRONO PCA 50 |
CANE S.R.L. |
CARLO MUSSO |
| K052595 |
11/08/2005 |
CRC 15ULTRA |
CAPINTEC, INC. |
MARY ANNE DELL |
| K040832 |
11/10/2005 |
C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 |
CARDICA, INC. |
SEVRINA CIUCCI |
| K051226 |
11/17/2005 |
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER |
Cardinal Health |
SHARON NICHOLS |
| K052568 |
11/28/2005 |
ESTEEM STRETCHY VINYL GLOVE WITH COATING |
Cardinal Health |
AMY HOYD |
| K052268 |
11/02/2005 |
VISUCAM PRO NM |
CARL ZEISS MEDITEC AG |
KENT W JONES |
| K052455 |
11/23/2005 |
IMPRESSIX |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K050609 |
11/09/2005 |
AQUADEX SYSTEM |
CHF SOLUTIONS, INC. |
CHRIS SCAVOTTO |
| K053014 |
11/15/2005 |
POLY SILOXANE IMPRESSION MATERIAL |
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. |
JEANETTE SMITH |
| K052679 |
11/18/2005 |
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K051799 |
11/02/2005 |
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS |
COEUR, INC. |
DEBRA F MANNING |
| K053040 |
11/09/2005 |
PARACEM UNIVERSAL DC |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K052834 |
11/23/2005 |
MREYE EMBOLIZATION COIL |
COOK, INC. |
LISA M WEBB |
| K042691 |
11/08/2005 |
VERTEFIX VERTEBROPLASTY PROCEDURE SET |
COOK, INC. |
JENNIFER J BOSLEY |
| K053155 |
11/23/2005 |
VIMPLANT |
CYBERMED, INC. |
SONG NAK CHOI |
| K052496 |
11/04/2005 |
PRIMECHAIR |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
| K052883 |
11/01/2005 |
CARDIOSERVER |
DATRIX |
LINDA GLUCKMAN |
| K053083 |
11/30/2005 |
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH |
DATRIX |
LINDA GLUCKMAN |
| K052370 |
11/01/2005 |
CP BRACKET SYSTEM |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K053010 |
11/22/2005 |
VISTADENT AT COMPLETE, MODEL 3.1 |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K051711 |
11/15/2005 |
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS |
DENVER BIOMEDICAL, INC. |
NANCY SAUER |
| K053002 |
11/22/2005 |
DEPUY CMW 1 GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K053003 |
11/22/2005 |
DEPUY CMW 1, 2 AND 3 BONE CEMENTS |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K051757 |
11/10/2005 |
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 |
DIAGNOSTIC CHEMICALS LTD. |
PENNY WHITE |
| K051658 |
11/16/2005 |
INFINITY ALPHA |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K053114 |
11/15/2005 |
SILVERFIL |
DUNIA PERWIRA MANUFACTURING SDN. BHD. |
NARESH SANCHANA |
| K052314 |
11/09/2005 |
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE |
DYNAREX CORP. |
JAMES HURLMAN |
| K052938 |
11/17/2005 |
CR-PRO |
ERADLINK, INC. |
ALBERT KOUBA |
| K052401 |
11/28/2005 |
GYNECARE TVT SECUR SYSTEM |
ETHICON, INC. |
PATRICIA M HOJNOSKI |
| K050571 |
11/02/2005 |
ABSOLUTE AMERICA |
EURODENT S.P.A. |
AVI POLITI |
| K051455 |
11/23/2005 |
WIESLAB CAP MPO-ANCA |
EURODIAGNOSTICA |
WILLIAM L BOTELER JR. |
| K051458 |
11/22/2005 |
WIESLAB CAP PR-3 ANCA |
EURODIAGNOSTICA |
WILLIAM L BOTELER JR. |
| K052909 |
11/01/2005 |
EVENFLO ELAN BREAST PUMP |
EVENFLO COMPANY, INC. |
THOMAS A SPARNO |
| K050398 |
11/18/2005 |
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS |
EXACTECH, INC. |
Lisa Simpson |
| K052530 |
11/18/2005 |
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA |
GALIL MEDICAL LTD. |
JONATHAN S KAHN |
| K052253 |
11/02/2005 |
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K052995 |
11/08/2005 |
ADVANTAGE WORKSTATION 4.3. |
GE HEALTHCARE |
LARRY A KROGER |
| K052977 |
11/22/2005 |
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
| K052880 |
11/02/2005 |
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT |
GE HEALTHCARE |
JOEL C KENT |
| K052756 |
11/01/2005 |
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM |
GE HEALTHCARE |
JOEL KENT |
| K051734 |
11/23/2005 |
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 |
GE HEALTHCARE TECHNOLOGIES |
RAJ KASBEKAR |
| K043207 |
11/04/2005 |
OZONE GENERATOR |
GE INFRASTRUCTURE WATER & PROCESS TECHNOLOGIES |
CHARLENE NASH |
| K053009 |
11/17/2005 |
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K052978 |
11/09/2005 |
GE 1.5T SIGNA HDE MR SYSTEM |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K052897 |
11/08/2005 |
GE DEFINIUM AMX 700, MODEL AMX 700 |
GENERAL ELECTRIC MEDICAL SYSTEMS |
MARK STAUFFER |
| K052899 |
11/17/2005 |
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC |
Genesee BioMedical, Inc. |
JOHN T.M. WRIGHT |
| K052565 |
11/17/2005 |
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF |
Genesee BioMedical, Inc. |
JOHN T. M. WRIGHT |
| K052745 |
11/23/2005 |
ASSISTO ARM SYSTEMS |
GEOMED MEDIZIN-TECHNIK GMBH & CO. |
ANGELIKA SCHERP |
| K052605 |
11/10/2005 |
EXTERNAL FIXATION |
GEXFIX USA INC. |
LUCIO IMPROTA |
| K050473 |
11/14/2005 |
RBK PATELLA FEMORAL KNEE |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. |
CARL KNOBLOCH |
| K050024 |
11/17/2005 |
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS |
Guangzhou Wondfo Biotech Co., Ltd. |
HOWARD K MANN |
| K050550 |
11/09/2005 |
GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR |
GYRUS MEDICAL, INC. |
MARK JENSEN |
| K053000 |
11/21/2005 |
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) |
HAEMONETICS CORP. |
GABRIEL J MURACA |
| K052722 |
11/02/2005 |
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS |
HOSPIRA, INC. |
THOMAS KOZMA |
| K053038 |
11/22/2005 |
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K043007 |
11/07/2005 |
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 |
HYPHEN BIOMED |
OLA ANDERSON |
| K051401 |
11/30/2005 |
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER |
I-FLOW CORP. |
SHANE NOEHRE |
| K051144 |
11/18/2005 |
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA |
IBL-HAMBURG GMBH |
Gary Lehnus |
| K051713 |
11/18/2005 |
JBAIDS ANTHRAC DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K052618 |
11/17/2005 |
IMAGECAST PACS |
IDX SYSTEMS CORP. |
ROSINA ROBINSON |
| K051578 |
11/18/2005 |
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS |
Immunalysis Corporation |
MICHAEL VINCENT |
| K052505 |
11/04/2005 |
CALF IMPLANT, MODEL EC17-X |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
| K052504 |
11/04/2005 |
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
| K053046 |
11/08/2005 |
ILUMA ORTHOCAT/DENTALCAT |
IMTEC CORP. |
J. BRAD VANCE |
| K052662 |
11/30/2005 |
ONE STEP FSH MENOPAUSAL TEST |
IND DIAGNOSTIC INC. |
JASON PENG |
| K052545 |
11/08/2005 |
INFINITT G3 PACS |
INFINITT CO., LTD. |
CARL ALLETTO |
| K052624 |
11/16/2005 |
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE |
INION LTD. |
HANNA MARTTILA |
| K051821 |
11/25/2005 |
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K052059 |
11/22/2005 |
IUI CATHETER, MODEL 9057 |
INNTEC, INC. |
Gary Syring |
| K052663 |
11/04/2005 |
INO THERAPEUTICS INOBLENDER, MODEL 10004 |
INO THERAPEUTICS |
FREDERICK MONTGOMERY |
| K052264 |
11/23/2005 |
QUANTA LITE CCP3 IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K051450 |
11/10/2005 |
EXTENDED MEASUREMENTS SYSTEM |
INOVISE MEDICAL, INC. |
STEVE C HESLER |
| K053045 |
11/21/2005 |
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
INTEGRA LIFESCIENCES CORPORATION |
DONNA WALLACE |
| K052169 |
11/17/2005 |
IMC SURGICAL DRAPES |
INTERNATIONAL MEDSURG CONNECTION, INC. |
MANNY GUPTA |
| K052550 |
11/17/2005 |
IMC SURGICAL GOWNS |
INTL. MEDSURG CONNECTION, INC. |
MANNY GUPTA |
| K052791 |
11/04/2005 |
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEPHANIE ROBINSON |
| K052704 |
11/03/2005 |
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE |
INVIVO CORP. |
THOMAS E TYNES |
| K053017 |
11/16/2005 |
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS |
INVIVO CORPORATION |
THOMAS SCHUBERT |
| K053030 |
11/07/2005 |
J. MORITA AZ ULTRASONIC SYSTEM |
J. MORITA USA, INC. |
HOWARD ROWE |
| K052561 |
11/23/2005 |
TERUMO MICRO TAPERED PEN NEEDLE |
KOFU FACTORY OF TERUMO CORP. |
BARBARA SMITH |
| K052095 |
11/03/2005 |
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
MASAFUMI SAITO |
| K051998 |
11/03/2005 |
REGIUS MODEL 170 DIRECT DIGITIZER |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
MASAFUMI SAITO |
| K053084 |
11/16/2005 |
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM |
KONTRON MEDICAL SYSTEMS SAS |
LARRY WALKER |
| K050271 |
11/03/2005 |
KOWA GENESIS-D HAND-HELD RETINAL CAMERA |
KOWA CO. LTD. |
SATOHIKO TAKANISHI |
| K053026 |
11/10/2005 |
KOWA NONMYD 7, KOWA NONMYD A-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K051061 |
11/04/2005 |
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
MEATHER VIELE |
| K043367 |
11/17/2005 |
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE |
LACE ELECTRONICA S.R.L. |
IAN P GORDON |
| K052610 |
11/30/2005 |
IMAGE STAR II |
LAKESHORE TECHNOLOGIES INC. |
JACK RACE |
| K052980 |
11/30/2005 |
LIBERTY GLUCOSE CONTROL, MODEL 2120031 |
LIBERTY HEALTHCARE GROUP, INC. |
JOJN C GORMLEY |
| K053098 |
11/28/2005 |
OPTIUM DBM GEL AND PUTTY |
LIFENET |
DAVID KLEMENTOWSKI |
| K052526 |
11/15/2005 |
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES |
LUMENIS, INC. |
KAREN L BAKER |
| K051034 |
11/22/2005 |
URYXXON 200 URINE ANALYZER |
MACHEREY-NAGEL GMBH & CO., KG. |
EDUARDO MARCH |
| K052851 |
11/18/2005 |
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K052802 |
11/01/2005 |
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE |
MANAN MEDICAL PRODUCTS, INC. |
NICOHL R WILDING |
| K053025 |
11/10/2005 |
JOSTRA HLM TUBING SET |
MAQUET CARDIOPULMONARY AG |
KATHLEEN JOHNSON |
| K051280 |
11/30/2005 |
MEDCOMP SPLIT CATH II |
MEDCOMP |
JEAN CALLOW |
| K051149 |
11/18/2005 |
MEDITECH MODEL ABPM-04 |
MEDITECH KFT. |
BENNY ARAZY |
| K053042 |
11/17/2005 |
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE |
MEDRAD, INC. |
LISA A EWING |
| K052827 |
11/01/2005 |
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS |
MEDRAD, INC. |
LISA A EWING |
| K051330 |
11/18/2005 |
UVBIOTEK MODELS 3200B AND 4000B |
MEDTEK LIGHTING CORPORATION |
ROBERT T WAGNER |
| K051082 |
11/08/2005 |
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K052860 |
11/10/2005 |
CG FUTURE ANNULOPLASTY BAND |
MEDTRONIC HEART VALVES |
JULIE SHERMAN |
| K052431 |
11/29/2005 |
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 |
MEDTRONIC MINIMED |
JODIE ROGERS |
| K052432 |
11/29/2005 |
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 |
MEDTRONIC MINIMED |
JODIE ROGERS |
| K052524 |
11/22/2005 |
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT |
MEDTRONIC PERFUSION SYSTEMS |
BRUCE BACKLUND |
| K052931 |
11/16/2005 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K052413 |
11/17/2005 |
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 |
MEDTRONIC VASCULAR |
JULIE GOODE |
| K052650 |
11/04/2005 |
PIONEER U601 SERIES ASPIRATOR |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K051836 |
11/21/2005 |
SKELITE RESORBABLE CEMENT RESTRICTOR |
MILLENIUM BIOLOGIX, INC. |
ROBERT SCHIFF |
| K053018 |
11/08/2005 |
POLY SILOXANE IMPRESSION MATERIAL |
MILLENNIUM DENTAL INTERNATIONAL, INC. |
JEANETTE SMITH |
| K052018 |
11/04/2005 |
MILTEX LIGATING CLIP |
MILTEX, INC. |
CHARLES WEAVER |
| K052702 |
11/21/2005 |
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY |
MISONIX, INC. |
RONALD R MANNA |
| K051206 |
11/02/2005 |
Y2K2 ENTERNAL TUBE FLUID FILTER |
MOSS MEDICAL PRODUCTS |
GERALD MOSS |
| K052874 |
11/22/2005 |
SOPRANO HAIR REMOVAL DIODE LASER |
MSQ (M2) LTD. |
TATIANA EPSTEIN |
| K051963 |
11/23/2005 |
BE-CERTAIN PREGNANCY TEST |
NATUREPLEX, LLC |
VICTOR J SANTOS |
| K052186 |
11/10/2005 |
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P |
NELLCOR PURITAN BENNETT, INC. |
PATRICK GARVEY |
| K052474 |
11/10/2005 |
NIPRO HYPODERMIC NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
| K052829 |
11/10/2005 |
WRISTOX MODEL 3100 PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI ROTH |
| K052987 |
11/08/2005 |
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC |
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH |
CARL ALLETTO |
| K052304 |
11/23/2005 |
SUPER PORCELAIN EX-3 PRESS |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K052019 |
11/04/2005 |
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE |
NORTH COAST MEDICAL, INC. |
TARHAN KAYIHAN |
| K052494 |
11/03/2005 |
NOVABONE-BIOACTIVE SYNTHETIC GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K052228 |
11/09/2005 |
SMIT SLEEVE |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K051886 |
11/14/2005 |
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K051647 |
11/08/2005 |
FORTADERM ANTIMICROBIAL WOUND DRESSING |
ORGANOGENESIS, INC. |
PATRICK BILBO |
| K052477 |
11/30/2005 |
DAMON 3 MODIFIED |
ORMCO CORP. |
COLLEEN BOSWELL |
| K043048 |
11/23/2005 |
GRAFTON PLUS DBM PASTE |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K042707 |
11/30/2005 |
GRAFTON PLUS DBM PASTE |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K051759 |
11/17/2005 |
FLEXI-LITE, MODEL FL-V1.2 |
PERFORMANCE HYPERBARICS |
SPENCER FELDMAN |
| K052961 |
11/18/2005 |
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 |
11/02/2005 |
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
| K052377 |
11/17/2005 |
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
EGON PFEIL |
| K052518 |
11/16/2005 |
PIEZOSURGERY |
PIEZOSURGERY SRL |
Maria E Donawa |
| K053053 |
11/16/2005 |
PACP SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K052435 |
11/03/2005 |
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS |
PNEUMRX, INC. |
ANNE C WORDEN |
| K052099 |
11/21/2005 |
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ |
Polyganics BV |
JAN NIEUWENHUIS |
| K052256 |
11/10/2005 |
ANGIOJET XPEEDIOR 120 CATHETER |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| K052910 |
11/07/2005 |
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K052903 |
11/09/2005 |
PEDIATRIC FEEDING TUBE |
PROMEDIC, INC. |
PAUL DRYDEN |
| K052709 |
11/08/2005 |
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K051572 |
11/17/2005 |
KOKO LEGEND |
PULMONARY DATA SERVICES, INC. |
DONALD HENTON |
| K051161 |
11/22/2005 |
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) |
QUEST DIAGNOSTICS, INC. |
JAMES BOURLAND |
| K052900 |
11/28/2005 |
QUILL NONABSORBABLE NYLON BARBED SUTURE |
QUILL MEDICAL, INC. |
LOIS V SMART |
| K052092 |
11/22/2005 |
RPS ADENO DETECTOR |
RAPID PATHOGEN SCREENING |
ROBERT SAMBURSKY |
| K052148 |
11/09/2005 |
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K052405 |
11/16/2005 |
STERLING INTERFERENC SCREW HT |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
| K051102 |
11/23/2005 |
OMNIPICC PI |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
| K053059 |
11/28/2005 |
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK |
Roche Diagnostics |
RANDY JOHNSON |
| K053151 |
11/18/2005 |
RUBICOR MAGIC BREAST BIOPSY DEVICE |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K050883 |
11/04/2005 |
SAFERSLEEP SYSTEM |
SAFER SLEEP LLC |
STEVEN CHERNOFF |
| K052861 |
11/15/2005 |
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 |
SANARUS MEDICAL, INC. |
TRENA DEPEL |
| K052809 |
11/02/2005 |
SAUFLON FLAT COLOURED LENS CASE |
SAUFLON PHARMACEUTICALS, LTD. |
AZITTA JADALIZADEH |
| K050407 |
11/04/2005 |
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60 |
SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
| K052763 |
11/10/2005 |
STELLA CERVICAL PLATE |
SCIENT'X |
J. D. WEBB |
| K051804 |
11/01/2005 |
ABL80 FLEX ANALYZER |
SENDX MEDICAL, INC. |
DOREEN E MILFORD |
| K051114 |
11/25/2005 |
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K051111 |
11/17/2005 |
SENTINEL UIBC LIQUID |
SENTINEL CH. SRL |
DAVIDE SPADA |
| K052815 |
11/01/2005 |
QMS AMIKACIN REAGENTS |
SERADYN INC. |
JACK ROGERS |
| K051211 |
11/18/2005 |
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS |
SERADYN INC. |
JACK ROGERS |
| K052612 |
11/22/2005 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K052470 |
11/01/2005 |
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT |
SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD. |
DANIEL KAMM |
| K052182 |
11/04/2005 |
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. |
SHIAN JIA MEEI ENTERPRISE CO., LTD. |
JENNIFER REICH |
| K052033 |
11/18/2005 |
VINTAGE ZR |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K053024 |
11/04/2005 |
SYNGO NEURO DSA CT |
SIEMENS AG |
RUEDIGER KOERNER |
| K052331 |
11/10/2005 |
ACUSON CYPRESS ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K052894 |
11/23/2005 |
SONOLINE G60 S ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K052533 |
11/03/2005 |
KIMBA SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
| K052576 |
11/07/2005 |
SBI AUTOFIX |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
| K050209 |
11/23/2005 |
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K051568 |
11/17/2005 |
CADD-MS 3 AMBULATORY INFUSION PUMP |
SMITHS MEDICAL MD, INC. |
MELANIE HESS |
| K051274 |
11/04/2005 |
INVOS SYSTEM |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K053069 |
11/16/2005 |
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
SONOSITE,INC. |
DAINA L GRAHAM |
| K052406 |
11/07/2005 |
UNI-THREAD SPINAL SYSTEM |
SPINE VISION, INC |
LYNNETTE WHITAKER |
| K052313 |
11/17/2005 |
STIMUPLEX HNS-12, MODEL 4892098 |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K051205 |
11/04/2005 |
STRYKER SPINE AVS ASL PEEK SPACER |
STRYKER SPINE |
SIMONA VOIC |
| K052971 |
11/16/2005 |
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052699 |
11/16/2005 |
VERSA-LINK PORCELAIN BONDING SYSTEM |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K052852 |
11/14/2005 |
SUPERDIMENSION/BRONCHUS PREMIUM |
SUPERDIMENSION, LTD. |
GEORGE MYERS |
| K052437 |
11/07/2005 |
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K052675 |
11/30/2005 |
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS |
SYNERGEYES |
RICHARD E LIPPMAN |
| K052877 |
11/08/2005 |
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
MICKY LIN |
| K052483 |
11/04/2005 |
SYNTHES (USA) SPHERICAL WASHERS |
SYNTHES (USA) |
LISA M BOYLE |
| K052872 |
11/23/2005 |
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K052932 |
11/04/2005 |
CRYPTOSPORIDIUM II |
TECHLAB, INC. |
DAVID M LYERLY |
| K051929 |
11/17/2005 |
GIARDIA/CRYPTOSPORIDIUM CHEK |
TECHLAB, INC. |
DAVID M LYRLY |
| K052636 |
11/10/2005 |
TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
TEH LOONG CORP. |
CHIEN LIN |
| K052837 |
11/21/2005 |
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA |
TERANG NUSA SDN BHD |
CHIN GUAN LOW |
| K051299 |
11/23/2005 |
IGD DIAGNOSTIC TEST KITS |
THE BINDING SITE LTD. |
JAY H GELLER |
| K052507 |
11/02/2005 |
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR |
THE LAGADO CORP. |
JOHN M SZABOCSIK |
| K051583 |
11/04/2005 |
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 |
TIARA MEDICAL SYSTEMS, INC. |
GEOFFREY SLEEPER |
| K051023 |
11/15/2005 |
TOPEZ TOTAL ANKLE REPLACEMENT |
TOPEZ ORTHOPEDICS, INC |
LEWIS WARD |
| K053043 |
11/18/2005 |
ENCOMPASS SOFTWARE PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K052916 |
11/09/2005 |
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
| K052814 |
11/30/2005 |
LUMINA 1600, 3300 AND 6600 SYSTEMS |
USA LASER BIOTECH INC. |
M. JOYCE HEINRICH |
| K050296 |
11/03/2005 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K052391 |
11/23/2005 |
VISION (WITH OFF-LINE REVIEW) |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K053054 |
11/23/2005 |
THROMBIX 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K052257 |
11/23/2005 |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
| K051312 |
11/04/2005 |
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS |
VERYAN MEDICAL LIMITED |
JUDITH DANIELSON |
| K052408 |
11/17/2005 |
EZ-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K052195 |
11/02/2005 |
EZ-MIO MANUAL DRIVER |
VIDACARE CORPORATION |
GREG HOLLAND |
| K052196 |
11/22/2005 |
VILEX X-FIX |
VILEX, INC. |
ABRAHAM LAVI |
| K051826 |
11/18/2005 |
BETACONE HIP PROSTHESIS SYSTEM |
WALDEMAR LINK GMBH & CO. KG |
JANICE M HOGAN |
| K052784 |
11/22/2005 |
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 |
WELCH ALLYN, INC. |
CHRIS KLACZKY |
| K053027 |
11/22/2005 |
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) |
WELCH ALLYN, INC. |
JOHN E SAWYER |
| K052913 |
11/07/2005 |
IGNITE BONE VOID FILLER KIT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K052502 |
11/18/2005 |
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K052381 |
11/21/2005 |
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER |
ZERUSA LIMITED |
OONAGH SWEENEY |
| K052950 |
11/16/2005 |
THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM |
ZIMMER TRABECULAR |
MARCI HALEVI |
| K052879 |
11/22/2005 |
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS |
ZIMMER, INC. |
BRANDON HIPSHER |
