FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K052638 |
09/26/2005 |
ABBOTT SPINE, INC. SPINNAKER SYSTEM |
ABBOTT SPINE, INC. |
LISA PETERSON |
K052566 |
09/19/2005 |
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY |
ABBOTT SPINE, INC. |
NOAH BARTSCH |
K052454 |
09/06/2005 |
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM |
ABBOTT VASCULAR DEVICES |
DEBBIE COGAN |
K052732 |
09/29/2005 |
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P |
ABRACAIR, INC. |
DAVID CHANGARIS |
K052744 |
09/30/2005 |
C2000 AUTOMATED MANIFOLD KIT |
ACIST MEDICAL SYSTEMS, INC. |
A; SAALABI |
K052418 |
09/02/2005 |
AXXESS BUTTERFLY ANCHOR |
ADVANCED NEUROMODULATION SYSTEMS |
STEVE TAMSETT |
K052439 |
09/06/2005 |
AESKULISA GLIA A AND AESKULISA GLIA G |
AESKU.DIAGNOSTICS |
STANLEY AMMONS |
K052762 |
09/30/2005 |
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 |
AGAMATRIX INC |
CONNIE HERTEL |
K052697 |
09/28/2005 |
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
K052703 |
09/28/2005 |
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL |
ALDEN OPTICAL LABS., INC. |
CHARLES H CREIGHTON |
K052603 |
09/21/2005 |
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
K052414 |
09/02/2005 |
REPROCESSED ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
K052733 |
09/29/2005 |
ALMITECH INC. DENTAL IMPLANT SYSTEM |
ALMITECH INC. |
ALEX BREYTMAN |
K052527 |
09/12/2005 |
NEUROPROBES |
ALPHA OMEGA ENGINEERING, LTD. |
SHLOMO PUNDAK |
K052443 |
09/06/2005 |
ICY CATHETER, MODEL IC-3893A |
ALSIUS CORP. |
KENNETH A COLLINS |
K052544 |
09/15/2005 |
PULSE OXIMETER ADAPTER CABLES |
AMERICAN I.V. PRODUCTS, INC. |
GREGORY FALK |
K052537 |
09/15/2005 |
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0 |
AMERICAN MEDICAL SALES, INC. |
CAROL M LIFLAND |
K052647 |
09/26/2005 |
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 |
K052548 |
09/16/2005 |
UROK ROCKING WHEELCHAIR, MODEL 700-4XX |
AMG MEDICAL INC. |
KENNETH LEVESQUE |
K052447 |
09/07/2005 |
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 |
ANALOGIC CORP. |
DONALD SHERRATT |
K052708 |
09/29/2005 |
PYLO-PLUS |
ARJ MEDICAL, INC. |
PHILIP ROSS |
K052719 |
09/29/2005 |
URITEST 10 URINALYSIS REAGENT STRIPS |
ARJ MEDICAL, INC. |
AARON BEHAR |
K052607 |
09/22/2005 |
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS |
ARTHREX, INC. |
ANN WATERHOUSE |
K052736 |
09/30/2005 |
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT |
ARTHREX, INC. |
ANN WATERHOUSE |
K052614 |
09/23/2005 |
LOW PROFILE PLATE AND SCREW SYSTEM |
ARTHREX, INC. |
SALLY FOUST |
K052686 |
09/28/2005 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K052482 |
09/09/2005 |
ARTELON SURGICAL SUTURE |
ARTIMPLANT AB |
MARIE MARLOW |
K052667 |
09/27/2005 |
ARTSANA PISTON AND INSULIN SYRINGES |
ARTSANA S.P.A. |
LARA N SIMMONS |
K052666 |
09/27/2005 |
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN |
ASCEND EAGLE, INC. |
JARILYN LIM |
K052698 |
09/28/2005 |
MODIFICATION TO: AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
MICHAEL A DOUGLAS |
K052541 |
09/15/2005 |
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM |
AVANT MEDICAL SYSTEMS |
DANIEL KAMM |
K052491 |
09/12/2005 |
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
K052764 |
09/30/2005 |
DIACAP ULTRA DIALYSIS FLUID FILTER |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCOTT J PEASE |
K052403 |
09/01/2005 |
CORONIS 2MP-21 AND MFGD 2621 |
BARCOVIEW |
LIEVEN DE WANDEL |
K052429 |
09/06/2005 |
CORONIS 3MP-21 AND MFGD 3621 |
BARCOVIEW |
LIEVEN DE WANDEL |
K052529 |
09/14/2005 |
E-2320 PA S |
BARCOVIEW |
LIEVEN DE WANDEL |
K052478 |
09/09/2005 |
MFCD 1219, MFCD 1219 TS |
BARCOVIEW |
LIEVEN DE WANDAL |
K052578 |
09/20/2005 |
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J |
BARD PERIPHERAL VASCULAR, INC. |
GENEVIEVE BALUTOWSKI |
K052503 |
09/13/2005 |
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
K052481 |
09/09/2005 |
BD VIPER SYSTEM |
BECTON, DICKINSON & CO. |
COLLEEN A KISTLER |
K052547 |
09/16/2005 |
BELMONT BUDDY FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
K052457 |
09/07/2005 |
PICSI SPERM SELECTION DEVICE |
BIOCOAT, INC. |
JAMES B JOHNSTON |
K052419 |
09/02/2005 |
MAXIMUS 3.0 AND OS IMPLANTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
K052656 |
09/26/2005 |
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K052639 |
09/26/2005 |
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER |
BIOMET MANUFACTURING, INC. |
SUSAN ALEXANDER |
K052685 |
09/28/2005 |
ORTHOPEDIC SALVAGE SYSTEM- OSS |
BIOMET, INC. |
ALLISON KOSKEY |
K052625 |
09/23/2005 |
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 |
BIONICARE MEDICAL TECHNOLOGIES, INC. |
KENT HOFFMAN |
K052596 |
09/21/2005 |
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 |
BIOPRO, INC. |
DAVID MRAK |
K052433 |
09/06/2005 |
PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
BIOPTICS, INC. |
JEFFREY ORACH |
K052646 |
09/26/2005 |
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
K052742 |
09/30/2005 |
HEPASPHERE MICROSPHERES |
BIOSPHERE MEDICAL, INC. |
ROSINA ROBINSON |
K052757 |
09/30/2005 |
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
BIOTRONIK AG |
Jon Brumbaugh |
K052608 |
09/22/2005 |
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
K052456 |
09/07/2005 |
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM |
BLUE SKY MEDICAL GROUP INCORPORATED |
JASPER BENKE |
K052517 |
09/14/2005 |
SITE-RITE 5 ULTRASOUND SYSTEM |
C.R. BARD, INC. |
KIMBERLY GEISLER |
K052595 |
09/21/2005 |
CRC 15ULTRA |
CAPINTEC, INC. |
MARY ANNE DELL |
K052556 |
09/16/2005 |
CG-7000DX-BT ECG RECORDER/TRANSMITTER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K052570 |
09/19/2005 |
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 |
CARDIAC ASSIST, INC. |
TIM KRAUSKOPF |
K052568 |
09/19/2005 |
ESTEEM STRETCHY VINYL GLOVE WITH COATING |
Cardinal Health |
AMY HOYD |
K052598 |
09/21/2005 |
IMMOCARE |
CARE DIAGNOSTIC, INC. |
ARACELI FANCHER-FERREIRA |
K052455 |
09/07/2005 |
IMPRESSIX |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
K052643 |
09/26/2005 |
EPICERAM |
CERAGENIX CORPORATION |
CARL GENBERG |
K052528 |
09/14/2005 |
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE |
CEREMED, INC. |
TADEUSZ WELLISZ |
K052725 |
09/29/2005 |
PROTECTOR NEEDLE SHEATH PROP |
CERTOL INTERNATIONAL, LLC |
LEWIS WARD |
K052591 |
09/21/2005 |
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT |
CLINICAL DATA, INC. |
ISRAEL M STEIN |
K052679 |
09/28/2005 |
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K052449 |
09/06/2005 |
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 |
Codman & Shurtleff, Inc. |
JOAN Q BARTLE |
K052687 |
09/28/2005 |
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
PATRICK HESS |
K052740 |
09/30/2005 |
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM |
CONMED INTEGRATED SYSTEMS (CMIS) |
C. JEFF LIPPS |
K052448 |
09/07/2005 |
POCKET BREATHALYZER. CONNECTABLES |
CONNECTABLES, LLC |
PHILLIP H CORSE |
K052539 |
09/15/2005 |
COOK FORMULA 418 BILIARY STENT SYSTEM |
COOK, INC. |
KAREN BRADBURN |
K052560 |
09/16/2005 |
BIOFINITY (COMFILCON A) SOFT CONTACT LENS |
COOPERVISION, INC. |
JACK P DOUGLAS |
K052501 |
09/13/2005 |
MULTIPLE RESIN TOOTH BONDING AGENT |
COSMEDENT, INC. |
JAMES L SANDRIK |
K052696 |
09/28/2005 |
COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING |
COVALON TECHNOLOGIES LTD. |
JACQUES LEMMETTI |
K052558 |
09/16/2005 |
VCS, MODEL S4T |
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC |
CHANG W LAN |
K052525 |
09/14/2005 |
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS |
D.F.I. CO LTD |
ASAD R ZAIDI |
K052496 |
09/12/2005 |
PRIMECHAIR |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K052534 |
09/15/2005 |
TACAHE |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
K052688 |
09/28/2005 |
ELLIPSE FLEX PPT, MODEL 9ESF7255 |
DANISH DERMATOLOGIC DEVELOPMENT A/S |
OLE KOFOD |
K052759 |
09/30/2005 |
DAN MONOPOLAR LAP ACCESSORIES |
DANNORITZER MEDIZINTECHNIK GMBH & CO. KG |
ANGELIKA SCHERP |
K052498 |
09/12/2005 |
FRAGMENT SPECIFIC FIXATOR |
DAVID J. SLUTSKY MD |
DAVID J SLUTSKY |
K052731 |
09/29/2005 |
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES |
DAXIN LI |
YINGCHAO XIAO |
K052513 |
09/14/2005 |
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 |
DELTA ENTERPRISE CORPORATION |
MARIA E CELIS |
K052532 |
09/15/2005 |
IMAX 9.5 STERILIZERS |
DENTAL X SRL |
CYNTHIA J.M. NOLTE |
K052593 |
09/21/2005 |
FUSION CURING LIGHT |
DENTLIGHT INC. |
RICHARD LIU |
K052436 |
09/06/2005 |
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 |
DENVER BIOMEDICAL, INC. |
JEFF HILL |
K052630 |
09/26/2005 |
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
K052631 |
09/26/2005 |
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DENISE LUCIANO |
K052472 |
09/08/2005 |
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
K052546 |
09/16/2005 |
AEGIS ANTERIOR LUMBAR PLATE SYSTEM |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K052746 |
09/30/2005 |
CONCORDE VBR SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
K052552 |
09/16/2005 |
HYBRID ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
LIZ LAVELLE |
K052536 |
09/15/2005 |
ALGICELL AG |
DERMA SCIENCES CANADA, INC. |
DELA SHARMINI ATHERAY |
K052551 |
09/16/2005 |
DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE |
DEVON SAFETY PRODUCTS, INC. |
BARRY L BERLER |
K052499 |
09/13/2005 |
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS |
DIASORIN S.P.A. |
MARI A MEYER |
K052717 |
09/29/2005 |
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER |
DIDECO S.R.L. |
BARRY SALL |
K052430 |
09/06/2005 |
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
K052705 |
09/28/2005 |
DART-12 |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K052649 |
09/26/2005 |
DRG SLV TESTOSTERONE ELISA TEST |
DRG INTL., INC. |
Gary Lehnus |
K052445 |
09/07/2005 |
DUOPROSS NEEDLE |
DUOPROSS MEDITECH CORPORATION |
FRANK FERGUSON |
K052754 |
09/30/2005 |
WRIST FUSION PLATE |
DVO EXTREMITY SOLUTIONS, LLC |
DINA L WEISSMAN |
K052743 |
09/30/2005 |
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 |
DYNAREX CORP. |
JAMES HURLMAN |
K052611 |
09/22/2005 |
ECP HEALTH SYSTEM, MODEL 2005 |
ECP HEALTH INC. |
SHAMON HUANG |
K052661 |
09/27/2005 |
QUIX DIGITAL RADIOGRAPHIC UPGRADE |
EDGE MEDICAL DEVICES LTD. |
VERED SCHARF |
K052438 |
09/06/2005 |
EMG HANDLE NEBULIZER NB02 SERIES |
EMG TECHNOLOGY CO., LTD. |
GENE R KULON |
K052711 |
09/29/2005 |
EMJOI TENS DEVICE |
EMJOI, INC. |
MIKE JUDGE |
K052479 |
09/09/2005 |
MBATH 1000 (60) |
ENNEKING MEDICAL INC. |
STEPHEN WHITTENBURG |
K052549 |
09/16/2005 |
LEADCARE II BLOOD LEAD TESTING SYSTEM |
ESA BIOSCIENCES INC. |
HAROLD ASP |
K052401 |
09/01/2005 |
GYNECARE TVT SECUR SYSTEM |
ETHICON, INC. |
PATRICIA M HOJNOSKI |
K052659 |
09/27/2005 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC |
GLEN D SMYTHE |
K052453 |
09/07/2005 |
TRACTION SYSTEM, DIGIT-TRAC 930 |
EVER PROSPEROUS INSTRUMENT, INC. |
KE-MEN JEN |
K052714 |
09/29/2005 |
RAVE COMPOSITE BRACKET |
FDA AGENTS |
STEVE KLAMIC |
K052642 |
09/26/2005 |
SUTURING WASHER |
FIRST CALL, INC. |
DINA L WEISSMAN |
K052407 |
09/01/2005 |
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS |
FISHER DIAGNOSTICS |
M. HEATHER CAMERON |
K052422 |
09/02/2005 |
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) |
FLOW X-RAY CORP. |
SUSAN D GOLDSTEIN-FALK |
K052531 |
09/15/2005 |
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
FU HONG INDUSTRIES LTD. |
Kevin Walls |
K052530 |
09/14/2005 |
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA |
GALIL MEDICAL LTD. |
JONATHAN S KAHN |
K052462 |
09/08/2005 |
G-COAT |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
K052756 |
09/30/2005 |
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM |
GE HEALTHCARE |
JOEL KENT |
K052755 |
09/30/2005 |
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT |
GE HEALTHCARE |
JOEL KENT |
K052582 |
09/20/2005 |
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES |
GE HEALTHCARE |
JOEL KENT |
K052412 |
09/02/2005 |
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ |
GE HEALTHCARE |
LARRY A KROGER |
K052434 |
09/06/2005 |
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
GE MEDICAL SYSTEMS |
ELI WERNER |
K052581 |
09/20/2005 |
LUNAR IDXA |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
JAMES P RASKOB |
K052441 |
09/06/2005 |
GE LOGIQ 7 ULTRASOUND BT05 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K052565 |
09/19/2005 |
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF |
Genesee BioMedical, Inc. |
JOHN T. M. WRIGHT |
K052745 |
09/30/2005 |
ASSISTO ARM SYSTEMS |
GEOMED MEDIZIN-TECHNIK GMBH & CO. |
ANGELIKA SCHERP |
K052605 |
09/21/2005 |
EXTERNAL FIXATION |
GEXFIX USA INC. |
LUCIO IMPROTA |
K052617 |
09/23/2005 |
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, |
GOOD BIOTECH CORP. |
VICTOR CHIOU |
K052665 |
09/27/2005 |
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES |
GRANTON MEDICAL LTD. |
CYNTHIA J.M. NOLTE |
K052420 |
09/02/2005 |
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
GYNOVA, LLC |
DON GUINAN |
K052626 |
09/23/2005 |
SMARTSUCTION HARMONY DEVICE |
HAEMONETICS CORP. |
GABRIEL J MURACA |
K052416 |
09/02/2005 |
PERIPRO PATCH |
HANCOCK/JAFFE LABORATORIES |
SUE MONTOYA |
K052480 |
09/09/2005 |
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH |
HANSEN MEDICAL, INC. |
NINA PELED |
K052583 |
09/20/2005 |
BLUE POWDER FREE NITRILE EXAMINATION GLOVES |
HARTALEGA SDN BHD |
KUAN KAM HON |
K052471 |
09/08/2005 |
HDC SPIDER SCREW |
HDC S.R.L. |
MILLIE LYNN BENTLEY |
K052469 |
09/08/2005 |
GLUCOPACK |
HEALTHPIA AMERICA CORP. |
STEVEN KIM |
K052465 |
09/08/2005 |
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 |
HEARTSINE TECHNOLOGIES, INC. |
GEORGE BRDLIK |
K052723 |
09/29/2005 |
SEVEN STAR NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
K052543 |
09/15/2005 |
HERACERAM ZIRKONIA |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K052446 |
09/07/2005 |
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
MATTHEW S GLEI |
K052671 |
09/27/2005 |
HOCA EZ-CARE BP108, TENDER-CARE BP109 |
HOCA MEDICAL MICROSYSTEM, INC. |
JEN KE-MIN |
K052597 |
09/21/2005 |
BREATHEX OMEGA CPAP DEVICE, MODEL 322 |
HOFFMAN LABORATORIES, LLC |
KEITH BOSECKER |
K052722 |
09/29/2005 |
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS |
HOSPIRA, INC. |
THOMAS KOZMA |
K052748 |
09/30/2005 |
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K052718 |
09/29/2005 |
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
K052594 |
09/21/2005 |
WILLCARE, MODEL GW-1020 |
ICU MEDICAL INC |
SCOTT NELSON |
K052618 |
09/23/2005 |
IMAGECAST PACS |
IDX SYSTEMS CORP. |
ROSINA ROBINSON |
K052577 |
09/19/2005 |
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM |
IKONISYS INC |
S. MICHAEL SHARP |
K052648 |
09/26/2005 |
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
K052505 |
09/13/2005 |
CALF IMPLANT, MODEL EC17-X |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
K052504 |
09/13/2005 |
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
K052662 |
09/27/2005 |
ONE STEP FSH MENOPAUSAL TEST |
IND DIAGNOSTIC INC. |
JASON PENG |
K052694 |
09/28/2005 |
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. |
IND DIAGNOSTIC INC. |
JASON PENG |
K052545 |
09/15/2005 |
INFINITT G3 PACS |
INFINITT CO., LTD. |
CARL ALLETTO |
K052444 |
09/06/2005 |
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
K052624 |
09/23/2005 |
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE |
INION LTD. |
HANNA MARTTILA |
K052663 |
09/27/2005 |
INO THERAPEUTICS INOBLENDER, MODEL 10004 |
INO THERAPEUTICS |
FREDERICK MONTGOMERY |
K052468 |
09/08/2005 |
YK9000 SERIES MANUAL WHEELCHAIR |
INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. |
JOHN ZHAO |
K052473 |
09/09/2005 |
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 |
INTER MEDICAL MEDIZINTECHNIK GMBH |
HANS GUENTER OSIEK |
K052562 |
09/19/2005 |
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. |
INTERACOUSTICS AS |
DANIEL EGGAN |
K052550 |
09/16/2005 |
IMC SURGICAL GOWNS |
INTL. MEDSURG CONNECTION, INC. |
MANNY GUPTA |
K052704 |
09/28/2005 |
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE |
INVIVO CORP. |
THOMAS E TYNES |
K052497 |
09/12/2005 |
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A |
INVIVO CORP. |
TOM SCHUBERT |
K052587 |
09/20/2005 |
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF |
J. MORITA USA, INC. |
KEITH A BARRITT |
K052574 |
09/19/2005 |
COMPACT PLUS - EXTREME - PERFECT PLUS |
J.O. SUAREZ & CIA, LTDA |
JAVIER O SUAREZ |
K052404 |
09/01/2005 |
DENALI DEFORMITY SYSTEM |
K2M, LLC |
RICHARD W WOODS |
K052680 |
09/28/2005 |
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
K052673 |
09/27/2005 |
KING I POWERED SCOOTER, MODEL CTL-11 |
KING I TECH CORPORATION |
Ke-Min Jen |
K052676 |
09/27/2005 |
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
K052450 |
09/07/2005 |
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
K052561 |
09/19/2005 |
TERUMO MICRO TAPERED PEN NEEDLE |
KOFU FACTORY OF TERUMO CORP. |
BARBARA SMITH |
K052467 |
09/08/2005 |
BRAIN VIEWRX VIEWER, VERSION 1.0 |
KYRON CLINICAL IMAGING, INC. |
JAMES L REUSS |
K052610 |
09/22/2005 |
IMAGE STAR II |
LAKESHORE TECHNOLOGIES INC. |
JACK RACE |
K052604 |
09/21/2005 |
STARLITE 2006 |
LASER DENTAL INNOVATIONS |
HOWARD FEINBERG |
K052767 |
09/30/2005 |
AFIBALERT ATRIAL FIBRILLATION DETECTOR |
LECHNOLOGIES RESEARCH INC. |
TIM LOHMAN |
K052735 |
09/30/2005 |
ALLOCRAFT DBM |
LIFECELL CORP. |
HOWARD M HOLSTEIN |
K052678 |
09/28/2005 |
AQ-830 SLIM BODY, BODY FAT MONITOR |
LIMAX ELECTRONICS CO., LTD. |
JENNIFER REICH |
K052458 |
09/07/2005 |
LIV MEDICA CPR FACE MASK |
LIV MEDICA PRODUCTS PVT. LTD. |
MICHAEL HOLSTEIN |
K052715 |
09/29/2005 |
CALM CURVE, VERSION 01.00 |
LMS MEDICAL SYSTEMS (CANADA), LTD. |
PAMELA HASWELL |
K052526 |
09/14/2005 |
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES |
LUMENIS, INC. |
KAREN L BAKER |
K052728 |
09/29/2005 |
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES |
M/S. KANAM LATEX INDUSTRIES PVT. LTD. |
RAVI ABRAHAM |
K052622 |
09/23/2005 |
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT |
MACAN ENGINEERING CO. |
MICKEY ALBERGO |
K052606 |
09/22/2005 |
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS |
MARIETTA VISION |
MARTIN DALSING |
K052563 |
09/19/2005 |
INOGEN SATELLITE CONSERVER, MODEL SC-100 |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
K052495 |
09/12/2005 |
ATRILAZE MALLEABLE ABLATION PROBE |
MEDICALCV, INC. |
DENNY STEGER |
K052424 |
09/02/2005 |
MAXILIM |
MEDICIM NV |
JOSEPH AZARY |
K052751 |
09/30/2005 |
VENTLINK SYSTEM |
MEDISERVE INFORMATION SYSTEMS, INC. |
MARK OFORI-KYEI |
K052615 |
09/23/2005 |
MEDISIZE GOLD |
MEDISIZE BV |
SOPIHA LAM |
K052674 |
09/27/2005 |
CONTACT LENS OPHTHALMODYNAMOMETER |
MEDITRON, GMBH |
ROBERT N CLARK |
K052720 |
09/29/2005 |
MEDLINE IODOFORM PACKING STRIPS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
K052431 |
09/06/2005 |
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 |
MEDTRONIC MINIMED |
JODIE ROGERS |
K052432 |
09/06/2005 |
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 |
MEDTRONIC MINIMED |
JODIE ROGERS |
K052623 |
09/23/2005 |
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
TINA DREILING |
K052524 |
09/14/2005 |
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT |
MEDTRONIC PERFUSION SYSTEMS |
BRUCE BACKLUND |
K052609 |
09/22/2005 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K052734 |
09/30/2005 |
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K052747 |
09/30/2005 |
MODIFICATION TO:CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K052402 |
09/01/2005 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K052459 |
09/07/2005 |
6248VAL ADJUSTABLE VALVE |
MEDTRONIC VASCULAR |
MICHELLE NIVALA |
K052413 |
09/02/2005 |
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 |
MEDTRONIC VASCULAR |
JULIE GOODE |
K052440 |
09/06/2005 |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
MENTOR CORPORATION |
DONNA A CRAWFORD |
K052650 |
09/26/2005 |
PIONEER U601 SERIES ASPIRATOR |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
K052485 |
09/09/2005 |
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF |
MIDI, INC. |
WILLIAM STIMSON |
K052721 |
09/29/2005 |
MINXRAY, MODEL HF100H+ |
MINXRAY, INC. |
DANIEL KAMM |
K052702 |
09/28/2005 |
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY |
MISONIX, INC. |
RONALD R MANNA |
K052451 |
09/07/2005 |
MPS ACACIA MEDFLO ELASTOMERIC PUMP |
MPS ACACIA |
FERGIE FERGUSON |
K052492 |
09/12/2005 |
AIRNERGY+STREAM |
NATURAL ENERGY SOLUTIONS AG |
MARTINA GUNDEROTH |
K052633 |
09/26/2005 |
DUAL SHOT - CONTRAST DELIVERY SYSTEM |
NEMOTO KYORINDO CO., LTD. |
TOSHIO KANETAKA |
K052571 |
09/19/2005 |
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 |
NEUROGNOSTICS, INC. |
Hrishikesh Gadagkar |
K052511 |
09/14/2005 |
CARDIOFAX CE, MODEL ECG-1500 A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K052474 |
09/09/2005 |
NIPRO HYPODERMIC NEEDLE |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
K052521 |
09/14/2005 |
NISSIN SERIES MECHANICAL WHEELCHAIR |
NISSIN MEDICAL INDUSTRIES CO., LTD |
DARREN REEVES |
K052669 |
09/27/2005 |
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 |
NONIN MEDICAL, INC. |
LORI M ROTH |
K052490 |
09/12/2005 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
NORTHERN IMPLANTS, LLC |
GRETA M HOLS |
K052494 |
09/12/2005 |
NOVABONE-BIOACTIVE SYNTHETIC GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
K052700 |
09/28/2005 |
PANA-SPRAY |
NSK AMERICA CORP. |
HIROHIKO MURASE |
K052452 |
09/06/2005 |
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K052428 |
09/02/2005 |
RESOLUTION ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
K052668 |
09/27/2005 |
OR SPECIFIC BIG CASE BACK TABLE COVER |
OR SPECIFIC, INC. |
Daniel Becker |
K052477 |
09/09/2005 |
DAMON 3 MODIFIED |
ORMCO CORP. |
COLLEEN BOSWELL |
K052645 |
09/26/2005 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; |
ORTHO-CLINICAL DIAGNOSTICS |
MICHAEL M BYRNE |
K052538 |
09/15/2005 |
S-BONE HIP TOOL |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
K052716 |
09/29/2005 |
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR |
K052771 |
09/30/2005 |
SENSOR WALK |
OTTO BOCK HEALTH CARE, LP |
BILL CLOVER |
K052681 |
09/28/2005 |
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) |
OTTO BOCK HEALTH CARE, LP |
BOB CLARKE |
K052706 |
09/28/2005 |
A-200 POWERED WHEELCHAIR |
OTTO BOCK HEALTHCARE, LP |
BOB CLARKE |
K052770 |
09/30/2005 |
PATHFORMER |
PATH SCIENTIFIC, LLC |
PATSY J TRISLER |
K052701 |
09/28/2005 |
COROLENE |
PETERS SURGICAL |
ANNIE LASSERRE |
K052707 |
09/29/2005 |
M3046B COMPACT PORTABLE PATIENT MONITORS |
PHILIPS MEDICAL SYSTEMS |
MICHAEL J DOYLE |
K052640 |
09/26/2005 |
GEMINI RAPTOR |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MELINDA NOVATNY |
K052518 |
09/14/2005 |
PIEZOSURGERY |
PIEZOSURGERY SRL |
Maria E Donawa |
K052435 |
09/06/2005 |
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS |
PNEUMRX, INC. |
ANNE C WORDEN |
K052579 |
09/20/2005 |
PORTAL GRAVITY SYSTEM |
PORTAL, INC. |
DAVID CARTER |
K052415 |
09/02/2005 |
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K052486 |
09/09/2005 |
PROASIA, MODEL L4501 |
PROASIA LIMITED |
JEFF CHANG |
K052463 |
09/08/2005 |
PROMETAL HN86 |
PROMETAL TECHNOLOGIES |
DONNA MARIE HARTNETT |
K052709 |
09/29/2005 |
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
K052641 |
09/26/2005 |
MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
JASON BLAIN |
K052442 |
09/06/2005 |
RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY |
RADIANCY (ISRAEL) LTD. |
MARGARET R FOURTE |
K052460 |
09/07/2005 |
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE |
RAMSOFT, INC. |
VIJAY RAMANATHAN |
K052555 |
09/16/2005 |
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB |
RAND S.R.L. |
PREETI JAIN |
K052651 |
09/26/2005 |
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02 |
RAYNER SURGICAL INC |
MARK MULLANEY |
K052405 |
09/01/2005 |
STERLING INTERFERENC SCREW HT |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
K052658 |
09/27/2005 |
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET |
RENASCENCE MEDICAL, INC. |
DANIEL DYAR |
K052489 |
09/12/2005 |
ACTIHEART |
RESPIRONICS, INC. |
ZITA A YURKO |
K052573 |
09/19/2005 |
STARDUST II |
RESPIRONICS, INC. |
ZITA A YURKO |
K052464 |
09/08/2005 |
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K052727 |
09/29/2005 |
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 |
ROSSMAX INTERNATIONAL LTD. |
YOLANDA LIN |
K052506 |
09/13/2005 |
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
K052553 |
09/16/2005 |
NITOM LOCKING FACEBOW |
RUSSELL SAMUELS ORTHODONTIC DESIGN |
RUSSELL HENRY ASHLEIGH SAMUELS |
K052763 |
09/30/2005 |
STELLA CERVICAL PLATE |
SCIENT'X |
J. D. WEBB |
K052509 |
09/13/2005 |
M-BOLUS EMBOLIC MICROSPHERES |
SCION CARDIO-VASCULAR, INC. |
SUZANA OTANO-LATA |
K052713 |
09/29/2005 |
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER |
SECHRIST INDUSTRIES, INC. |
GREG GODFREY |
K052612 |
09/22/2005 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
K052470 |
09/08/2005 |
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT |
SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD. |
DANIEL KAMM |
K052693 |
09/28/2005 |
PM-50 PULSE OXIMETER |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K052729 |
09/29/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
CHU XIAOAN |
K052500 |
09/13/2005 |
DAR-8000F |
SHIMADZU MEDICAL SYSTEMS |
RANDAL WALKER |
K052461 |
09/08/2005 |
SYNGO IMAGING VERSION V20A |
SIEMENS AG, MEDICAL SOLUTIONS |
EVA-MARIA REITER |
K052410 |
09/02/2005 |
ACUSON SEQUOIA ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
K052423 |
09/02/2005 |
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION |
SIEMENS MEDICAL SOLUTIONS, INC. |
JUDITH CAMPBELL |
K052533 |
09/15/2005 |
KIMBA SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K052515 |
09/14/2005 |
SIROENDO |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
K052576 |
09/19/2005 |
SBI AUTOFIX |
SMALL BONE INNOVATIONS, LLC |
DONALD GUTHNER |
K052652 |
09/26/2005 |
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
K052426 |
09/02/2005 |
SMITH & NEPHEW MODULAR HIP |
SMITH & NEPHEW, INC. |
JASON SELLS |
K052654 |
09/26/2005 |
KLOCKNER DENTAL IMPLANT, MODEL S3M |
SOADCO, S.L. |
MARIA MITJANETA |
K052601 |
09/21/2005 |
STOCKERT HEATER-COOLER SYSTEM 3T |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
K052519 |
09/14/2005 |
SPECTRAL WEST NILE VIRUS IGM STATUS TEST |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
K052514 |
09/14/2005 |
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 |
SPECTRANETICS CORP. |
NEIL BURRIS |
K052406 |
09/01/2005 |
UNI-THREAD SPINAL SYSTEM |
SPINE VISION, INC |
LYNNETTE WHITAKER |
K052670 |
09/27/2005 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
RONALD K SMITH |
K052575 |
09/19/2005 |
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN |
ST. JUDE MEDICAL |
PATRICE STROMBERG |
K052644 |
09/26/2005 |
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER |
ST. JUDE MEDICAL |
GLENN JACQUES |
K052522 |
09/14/2005 |
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 |
STAYHEALTHY, INC. |
COLIN K HILL |
K052493 |
09/12/2005 |
SOCKET GRAFT |
STEINER LABORATORIES |
GREGORY GENE STEINER |
K052567 |
09/19/2005 |
ONE TRAY SEALED STERILIZATION CONTAINER |
STERILE CONTAINMENT TECHNOLOGY, LLC. |
GAGE GARMAN |
K052516 |
09/14/2005 |
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
K052542 |
09/15/2005 |
ACCOLADE RPS HIP STEM |
STRYKER ORTHOPAEDICS |
TIFFANI ROGERS |
K052761 |
09/30/2005 |
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K052409 |
09/01/2005 |
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
K052699 |
09/28/2005 |
VERSA-LINK PORCELAIN BONDING SYSTEM |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
K052695 |
09/28/2005 |
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS |
SURETEK MEDICAL |
MIKE SAMMON |
K052691 |
09/28/2005 |
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES |
SURETEK MEDICAL |
MIKE SAMMON |
K052692 |
09/28/2005 |
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES |
SURETEK MEDICAL |
MIKE SAMMON |
K052690 |
09/28/2005 |
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS |
SURETEK MEDICAL |
MIKE SAMMON |
K052437 |
09/06/2005 |
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K052599 |
09/21/2005 |
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A |
SUZHOU 66 VISION TECH CO., LTD. |
GONG BO |
K052675 |
09/27/2005 |
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS |
SYNERGEYES |
RICHARD E LIPPMAN |
K052483 |
09/09/2005 |
SYNTHES (USA) SPHERICAL WASHERS |
SYNTHES (USA) |
LISA M BOYLE |
K052683 |
09/28/2005 |
SYNTHES (USA) STERNAL FIXATION SYSTEM |
SYNTHES (USA) |
Lisa Boyle |
K052677 |
09/28/2005 |
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K052619 |
09/23/2005 |
THE FINGER GUARD |
T F & G PRODUCTS |
MARIRUTH GURLEY |
K052586 |
09/20/2005 |
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P |
TAIWAN AN I CO.,LTD. |
Kevin Walls |
K052724 |
09/29/2005 |
TECO ISE REAGENT SET FOR CX SYSTEM |
TECO DIAGNOSTICS |
JIAN VAECHES |
K052636 |
09/26/2005 |
TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
TEH LOONG CORP. |
CHIEN LIN |
K052634 |
09/26/2005 |
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE |
TEH LOONG CORP. |
CHIEN LIN |
K052635 |
09/26/2005 |
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
TEH LOONG CORP. |
CHIEN LIN |
K052572 |
09/19/2005 |
ANSPACH KNOTLESS ANCHOR |
THE ANSPACH EFFORT, INC. |
WILLIAM CONETY |
K052507 |
09/13/2005 |
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR |
THE LAGADO CORP. |
JOHN M SZABOCSIK |
K052660 |
09/27/2005 |
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO |
THE RICHMOND LIGHT CO. |
ALEX M CLARKE |
K052637 |
09/26/2005 |
THEROX INFUSION CATHETER, MODEL INCA-1 |
THEROX, INC. |
DAVID W MULLIS JR. |
K052520 |
09/14/2005 |
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 |
K052557 |
09/16/2005 |
SUPER SHEATH INTRODUCER SHEATH |
TOGO MEDIKIT CO., LTD. |
HEIDI M ERICKSON |
K052584 |
09/20/2005 |
1.5T 12 CHANNEL BODY ARRAY |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
K052621 |
09/23/2005 |
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL |
USA INSTRUMENTS, INC. |
ROBERT B SMITH |
K052585 |
09/20/2005 |
3T HD BREAST ARRAY |
USA INSTRUMENTS, INC. |
DAVID BROWN |
K052738 |
09/30/2005 |
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 |
VEINRX INC. |
GREGORY J MATHISON |
K052523 |
09/14/2005 |
PROXIS SYSTEM |
VELOCIMED INC. |
KIMBERLY BRIGGS |
K052554 |
09/16/2005 |
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
K052408 |
09/01/2005 |
EZ-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
K052710 |
09/29/2005 |
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, |
VIDENT |
BARBARA J LEWANDOWSKI |
K052682 |
09/28/2005 |
ALIGNRT |
VISION RT LIMITED |
NORMAN SMITH |
K052632 |
09/26/2005 |
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K052564 |
09/19/2005 |
VYGON LEADER-FLEX |
VYGON CORP. |
COURTNEY SMITH |
K052475 |
09/09/2005 |
VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS |
VYGON US LLC |
COURTNEY SMITH |
K052741 |
09/30/2005 |
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES |
W & H DENTALWERK BUERMOOS GMBH |
GABRIELE WIENBECK |
K052559 |
09/16/2005 |
WU'S POWERED WHEELCHAIR, MAMBO 2 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
K052502 |
09/13/2005 |
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
K052600 |
09/21/2005 |
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) |
ZIMMER DENTAL INC. |
ERIN MCVEY |
K052425 |
09/02/2005 |
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION |
ZIMMER, INC. |
STEPHEN H MCKELVEY |