| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080960 |
09/05/2008 |
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS |
ABBOTT DIABETES CARE INC. |
TAMMY WHARTON |
| K081231 |
09/26/2008 |
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 |
ABBOTT LABORATORIES |
CAROL JOCHUM |
| K080696 |
09/11/2008 |
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 |
ABBOTT LABORATORIES |
CAROL JOCHUM |
| K081523 |
09/11/2008 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
DANIELLE TAYLOR |
| K082188 |
09/19/2008 |
TYMPANOSTOMY TUBE |
ACCLARENT, INC. |
KERI YEN |
| K082459 |
09/19/2008 |
ACRYDERM ABSORBENT OXYGEN DRESSING |
ACRYMED, INC. |
BRUCE GIBBINS |
| K081588 |
09/03/2008 |
RE-ZORB PLATING SYSTEM |
ACUTE INNOVATIONS LLC |
ALYSSA THOMAS |
| K081363 |
09/24/2008 |
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K080719 |
09/12/2008 |
YEAST TRAFFIC LIGHT PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K080992 |
09/04/2008 |
AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
Lisa Boyle |
| K082146 |
09/09/2008 |
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K081293 |
09/22/2008 |
UNIVATION UNICONDYLAR KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K082226 |
09/18/2008 |
S40 CREATINE KINASE (CK) |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DENNIS TASCHEK |
| K081730 |
09/19/2008 |
NOVEL CERVICAL SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY SCANNERS |
| K082037 |
09/26/2008 |
SEEPLATE CERVICAL PLATE SYSTEM |
AMEDICA CORP. |
ADAM HERDER |
| K081613 |
09/17/2008 |
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS |
AMERICAN MEDICAL SYSTEMS, INC. |
SARAH PETERSON |
| K080803 |
09/22/2008 |
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 |
AMERICAN OPTISURGICAL, INC. |
DAVID SALZBERG |
| K082144 |
09/05/2008 |
AMICAS PACS, VERSION 6.0 |
AMICAS, INC. |
PATRICE JC NEDELEC |
| K081472 |
09/23/2008 |
SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K082073 |
09/11/2008 |
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K082562 |
09/30/2008 |
APPLIED BIOSYSTEMS 7500 FAST DX |
APPLIED BIOSYSTEMS INC |
JOHN D'ANGELO |
| K071803 |
09/05/2008 |
ARDS DENTAL IMPLANTS |
ARDS, LTD |
GEORGE J HATTUB |
| K073019 |
09/16/2008 |
SILVERMED ANTIMICROBIAL SILVER HYDROGEL |
ARGENTIS BIOMEDICAL INCORPORATED |
TONI MILLER |
| K073410 |
09/12/2008 |
SAVE RESUSCITATOR |
ARTIVENT CORPORATION |
GRACE HOLLAND |
| K082023 |
09/16/2008 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
| K080156 |
09/17/2008 |
OSSEOSPEED TM PROFILE SYSTEM |
ASTRA TECH AB |
LINDA K SCHULZ |
| K073425 |
09/16/2008 |
MODIFICATION TO AURORA MRI SYSTEM |
AURORA IMAGING TECHNOLOGY, INC. |
MICHAEL A DOUGLAS |
| K081742 |
09/17/2008 |
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 |
BAXANO, INC. |
TRENA DEPEL |
| K080933 |
09/26/2008 |
HANDHELD ECG MONITOR, MODEL MD100 |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K082087 |
09/11/2008 |
EYEFEEL OPHTHALMIC WARMER |
BIO-LIPID, INC. |
PAMELA FURMAN |
| K081547 |
09/08/2008 |
BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC |
BIO-MED U.S.A., INC. |
YOUNG CHI |
| K082036 |
09/08/2008 |
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK |
Bio-Rad Laboratories |
ELIZABETH PLATT |
| K082383 |
09/05/2008 |
FORTOSS VITAL |
BIOCOMPOSITES LTD. |
MARIE WHALLEY |
| K082141 |
09/03/2008 |
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 |
BIOKIT S.A. |
JOAN GUIXER |
| K080017 |
09/26/2008 |
VIDAS AFP ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K081451 |
09/18/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K081450 |
09/11/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K082395 |
09/18/2008 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K081656 |
09/10/2008 |
VISUALASE THERMAL THERAPY SYSTEM |
BIOTEX, INC. |
ROGER MCNICHOLS |
| K082293 |
09/09/2008 |
SURGVIEW INTEGRATED VISUALIZATION SYSTEM |
BIOVISION TECHNOLOGIES, LLC |
|
| K082449 |
09/25/2008 |
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
BISCO, INC. |
Michelle Schiltz-Taing |
| K081684 |
09/15/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K082235 |
09/04/2008 |
BLACKSTONE PILLAR XL PEEK SPACERS |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K080332 |
09/05/2008 |
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 |
Boston Scientific Corporation |
ASHLEY PYLE |
| K073615 |
09/05/2008 |
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED |
BRAINLAB AG |
PER PERSSON |
| K081961 |
09/05/2008 |
3M UNITEK LAVA CHAIRSIDE ORAL SCANNER |
BRONTES TECHNOLOGIES |
JOHN GREENBAUM |
| K081042 |
09/03/2008 |
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
BSD MEDICAL SYSTEMS CORP. |
PHIL TRIOLO |
| K082571 |
09/30/2008 |
AVAULTA SUPPORT SYSTEM |
C.R. BARD, INC. |
JOHN C KNORPP |
| K081777 |
09/29/2008 |
VENTRIO HERNIA PATCH |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K082425 |
09/18/2008 |
TANDEMHEART TRANSSEPTAL CANNULA- EF 72 |
CARDIAC ASSIST, INC. |
ROBERT BOLLINGER |
| K081225 |
09/05/2008 |
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
ISKRA MRAKOVIC |
| K082542 |
09/17/2008 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A |
CARDICARE COMPANY, LTD. |
|
| K080570 |
09/30/2008 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
STEPHEN LINDSTROM |
| K082140 |
09/29/2008 |
XPERT MRSA/SA BLOOD CULTURE ASSAY |
CEPHEID |
RUSSEL K ENNS |
| K080837 |
09/24/2008 |
XPERT MRSA/SA SSTI ASSAY |
CEPHEID |
RUSSEL K ENNIS |
| K082245 |
09/18/2008 |
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K082491 |
09/24/2008 |
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K082159 |
09/30/2008 |
CIVASTRING PD-103 |
CIVATECH ONCOLOGY, INC. |
LOIS V SMART |
| K080196 |
09/05/2008 |
Z3D CONTRAST ACUITY |
CLARIO MEDICAL IMAGING, INC. |
CHRIS WOOD |
| K081602 |
09/19/2008 |
DIZZYFIX |
CLEARWATER CLINICAL LIMITED |
MATTHEW BROMWICH |
| K082107 |
09/17/2008 |
CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K080638 |
09/17/2008 |
CLARO |
CLRS TECHNOLOGY CORPORATION |
MAUREEN O'CONNELL |
| K081151 |
09/08/2008 |
COMPUMEDICS NEUVO |
COMPUMEDICS USA, LTD. |
DAVID CARDONA |
| K081644 |
09/10/2008 |
BEAMER ARGON PROBE |
CONMED CORPORATION |
KAREN PROVENCHER |
| K080531 |
09/05/2008 |
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY |
CONMED LINVATEC |
JON WARD |
| K071783 |
09/09/2008 |
VERSAPOD (TM) INSTRUMENT TRAYS |
CONTAINMED, INC. |
TODD E BETTENHAUSEN |
| K081987 |
09/26/2008 |
UNISYN IMAGE FUSION, VERSION 1.0 |
CONVERGENT IMAGING SOLUTIONS |
MATHEW A THOMAS |
| K082319 |
09/25/2008 |
INJEKT FILIFORM INJECTION NEEDLE |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K081425 |
09/30/2008 |
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT |
COOK VASCULAR, INC. |
JIM FERGUSON |
| K081865 |
09/29/2008 |
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K082324 |
09/12/2008 |
TRUFILL DCS SYRINGE |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K082077 |
09/02/2008 |
BT3/6, BT12 |
CORSCIENCE GMBH & CO. KG |
PATRIK KAREM |
| K082659 |
09/19/2008 |
MODIFIED ENDO STICH |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
| K081898 |
09/10/2008 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K081758 |
09/03/2008 |
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 |
DEPUY SPINE, INC. |
HANDE TUFAN |
| K082195 |
09/03/2008 |
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K082273 |
09/10/2008 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K082167 |
09/26/2008 |
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX |
DIGIMED CORPORATION |
SHIN KUK YOO |
| K082368 |
09/12/2008 |
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K082246 |
09/09/2008 |
DIGNITY 100 |
DIGNITY MEDICAL DEVICES, INC |
CHARMAINE SUTTON |
| K080382 |
09/24/2008 |
SELLAS |
DINONA CO., LTD. |
Kevin Walls |
| K081493 |
09/18/2008 |
INFILTRATION KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K081743 |
09/22/2008 |
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS |
DRAEGER MEDICAL AG & CO. KG |
KARIN LUEBBERS |
| K081694 |
09/12/2008 |
DENJECTOR |
DXM CO., LTD. |
MARIA GRIFFIN |
| K081569 |
09/12/2008 |
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS |
DYNAREX CORPORATION |
VIJAY SACHDEV |
| K081357 |
09/05/2008 |
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) |
EIZO GMBH |
JAMES BERGE |
| K081448 |
09/30/2008 |
ENCORE SHOULDER REVISION GLENOID |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K081394 |
09/15/2008 |
PTFE INTERLOCK PEELABLE INTRODUCERS |
ENPATH MEDICAL, INC. |
SHANNON SPRINGER |
| K082569 |
09/18/2008 |
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE |
Entellus Medical, Inc. |
Sew-Wah Tay |
| K082121 |
09/17/2008 |
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K081386 |
09/25/2008 |
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) |
ESAOTE S.P.A. |
Allison Scott |
| K082216 |
09/05/2008 |
TBD ETHICON MESH |
ETHICON INC. |
BRYAN A LISA |
| K082307 |
09/11/2008 |
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT |
EVENFLO COMPANY, INC. |
AMY NEFF |
| K082029 |
09/26/2008 |
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
KATHY LIU |
| K082022 |
09/02/2008 |
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ |
EXACTECH, INC. |
GRAHAM CUTHBERT |
| K073317 |
09/03/2008 |
STARLIGHT, MODEL PD9012 |
F.P. RUBINSTEIN Y CIA S.R.L. |
HAYDEE N DEMARCO |
| K080209 |
09/12/2008 |
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K081029 |
09/12/2008 |
SLEEPSTYLE 200 AUTO SERIES HC254 |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K080751 |
09/11/2008 |
ARCHITECT CYCLOSPORINE |
FUJIREBIO DIAGNOSTICS, INC. |
STACEY MOLL |
| K081919 |
09/09/2008 |
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM |
FUKUDA DENSHI CO., LTD. |
LORAN VAN NOY |
| K082656 |
09/30/2008 |
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT |
FUKUDA DENSHI USA, INC. |
LORAN VAN NOY |
| K082374 |
09/02/2008 |
VIVID I AND VIVID Q |
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
ISRAEL CITRON |
| K082104 |
09/02/2008 |
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM |
GE MEDICAL SYSTEMS, INC. |
STEVEN KACHELMEYER |
| K081985 |
09/25/2008 |
AW SERVER |
GE MEDICAL SYSTEMS, LLC |
STEPHEN SLAVENS |
| K082317 |
09/26/2008 |
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION |
GENERAL ELECTRIC CO. |
JAMES P RASKOB |
| K082484 |
09/12/2008 |
ACCELAWAVE SYSTEM |
GENESIS BIOSYSTEMS, INC. |
BRIAN BUSS |
| K081821 |
09/02/2008 |
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) |
GLOBAL PATHOGEN SOLUTIONS INC. |
CARSON LINKER |
| K081712 |
09/12/2008 |
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K081521 |
09/25/2008 |
MODIFICATION TO HAMILTON-G5 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K080682 |
09/11/2008 |
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE |
HANDPIECE HEADQUARTERS INC. - HPR INC. |
TINA STEFFANIE-OAK |
| K082616 |
09/26/2008 |
HASELMEIER PEN 8 |
HASELMEIER GMBH |
STEPHEN J GOLDNER |
| K081738 |
09/17/2008 |
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 |
HEALTH & LIFE CO., LTD. |
SAMUEL PIPER |
| K081442 |
09/24/2008 |
HEART SYNC PEDIATRIC, MODEL PED-100 |
HEART SYNC LLC |
STEPHEN SHULMAN |
| K082312 |
09/12/2008 |
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) |
HEARTSCAPE TECHNOLOGIES LTD |
PAUL PHILLIPS |
| K080221 |
09/09/2008 |
EA STIMULATOR |
HELIO MEDICAL SUPPLIES, INC. |
YUKUO HSO |
| K082206 |
09/04/2008 |
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES |
HELIX MEDICAL, LLC |
CYNTHIA ANDERSON |
| K082366 |
09/26/2008 |
LIFEBED PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
NANCY GERTLAR |
| K080711 |
09/02/2008 |
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION |
HOLOGIC, INC. |
BRYAN COWELL |
| K082483 |
09/12/2008 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE A WILLIAMS |
| K081276 |
09/12/2008 |
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H |
HORIBA ABX |
OLIVIER DUCAMP |
| K080579 |
09/11/2008 |
EFFECTIV (TM) CAP |
HOSPIRA, INC. |
REBECCA ANDERSEN |
| K082496 |
09/09/2008 |
PACSMATE MMD-3213M MONITOR |
IEI TECHNOLOGY CORP. |
SHALLY CHEN |
| K081653 |
09/19/2008 |
MDI MII ONE-PIECE IMPLANT, 2.9MM |
IMTEC CORP. |
GLENN GEE |
| K081782 |
09/30/2008 |
COLLIEVA |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K080602 |
09/25/2008 |
AUDICOR SENSOR, MODELS: 2.0, 3.0 |
INOVISE MEDICAL, INC. |
KENDRA RATHKEY |
| K073545 |
09/09/2008 |
AUDICOR, HEMO AMBULATORY MONITOR |
INOVISE MEDICAL, INC. |
KENDRA RATHKEY |
| K081925 |
09/02/2008 |
SNAPSHOT |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
JOUNI ONNELA |
| K081693 |
09/11/2008 |
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
| K081778 |
09/12/2008 |
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
| K082256 |
09/26/2008 |
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE |
INTEGRATED MEDICAL SYSTEMS, INC. |
RENATE A MACLAREN |
| K081614 |
09/05/2008 |
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES |
INTERBODY INNOVATIONS, LLP |
J.D. WEBB |
| K082047 |
09/30/2008 |
SECURACATH CATHETER, MODEL SPK01 |
INTERRAD MEDICAL, INC. |
Sew-Wah Tay |
| K081579 |
09/17/2008 |
INVENTUS IMPLANT SYSTEM |
INVENTUS CO., LTD |
ROSHANA AHMED |
| K070250 |
09/04/2008 |
NUTRITONE FACIAL BEAUTY SYSTEM |
ISOMERS LABORATORIES INC. |
ROBERT MAZZAFERRO |
| K081817 |
09/24/2008 |
ACCELL TBM-R |
ISOTIS ORTHOBIOLOGICS, INC |
JUDITH E O'GRADY |
| K081557 |
09/10/2008 |
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER |
JDDB MANUFACTURING, INC |
JACQUIN C YOUNGBLOOD-JOHNSON |
| K081658 |
09/30/2008 |
POWDER-FREE VINYL EXAMINATION GLOVES |
JIANGSU ALFA GLOVE CO., LTD |
CHU XIAOAN |
| K081267 |
09/23/2008 |
HYGEIA-5 OXYGEN CONCENTRATOR |
KEDL INTERNATION LIMITED |
Lee Leichter |
| K082560 |
09/08/2008 |
PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT |
KETTENBACH GMBH & CO KG |
MICHAELA ZINKE |
| K080795 |
09/03/2008 |
ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K082752 |
09/29/2008 |
QUICKPIN |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K081705 |
09/17/2008 |
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K081514 |
09/22/2008 |
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K082685 |
09/26/2008 |
GALAXY 55 |
LARSEN & TOUBRO LIMITED |
S.B. BHOSALE |
| K081371 |
09/24/2008 |
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K081864 |
09/25/2008 |
PROLONG |
LIFE-TECH, INC. |
JEFF KASOFF |
| K080788 |
09/17/2008 |
VIVASCOPE SYSTEM, MODEL 1500, 3000 |
LUCID, INC. |
JAMES JOY |
| K081704 |
09/11/2008 |
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS |
LUMENIS, INC. |
TINA MAYER |
| K072094 |
09/25/2008 |
CHOOSTENT |
M.I. TECH CO., LTD. |
DANIEL KAMM |
| K080592 |
09/11/2008 |
HLM TUBING SET WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENGLENKS |
| K080470 |
09/12/2008 |
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWEKGLENKS |
| K081659 |
09/09/2008 |
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K081236 |
09/25/2008 |
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME |
MCNEIL-PPC, INC. |
NADER FOTOUHI |
| K081904 |
09/23/2008 |
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) |
MEDCOMP |
JEAN CALLOW |
| K080473 |
09/03/2008 |
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED |
MEDICULT A/S |
RONALD G LEONARDI |
| K081639 |
09/19/2008 |
ICSI CUMULASE |
MEDICULT A/S |
RONALD G LEONARDI |
| K081784 |
09/17/2008 |
MASTERGRAFT PUTTY |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K082342 |
09/12/2008 |
MODIFICATION TO CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRIS MCKEE |
| K081277 |
09/05/2008 |
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
| K081443 |
09/23/2008 |
MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K081913 |
09/05/2008 |
METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K070488 |
09/04/2008 |
MICARDIA ANNULOPLASTY BAND DR |
MICARDIA CORPORATION |
JEFFREY P DUMONTELLE |
| K081800 |
09/24/2008 |
T12S TELEMETRY TRANSMITTER |
MORTARA INSTRUMENT, INC. |
LAURA SPIEGELHOFF |
| K080722 |
09/17/2008 |
PRIMADO SURGICAL DRILL |
NAKANISHI, INC. |
KEITH A BARRITT |
| K081553 |
09/29/2008 |
AED BIPOLAR FORCEPS, MODEL 13-1646 |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K081503 |
09/25/2008 |
AED MONOPOLAR LAP ACCESSORIES |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K081480 |
09/12/2008 |
KEGEL8 PELVIC EXERCISER, MODEL OPH 400 |
NE SERVICES LTD. |
BRENT REIDER |
| K081871 |
09/29/2008 |
UNIVERSAL ELECTRODES |
NEUROMETRIX, INC. |
RAINER MAAS |
| K082485 |
09/09/2008 |
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K081792 |
09/17/2008 |
SPY ANALYSIS TOOLKIT, MODEL SA9000 |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K082524 |
09/26/2008 |
MINI GHOST, MODEL: 507 |
NUMED, INC. |
NICHELLE LAFLESH |
| K082070 |
09/24/2008 |
NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073508 |
09/11/2008 |
PARKONE |
OCULUS OPTIKGERATE GMBH |
JOERG IWANCZUK |
| K080435 |
09/05/2008 |
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE G DONNELLY |
| K080094 |
09/03/2008 |
OLYMPUS TOTAL BHCG TEST SYSTEN |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE DONNELLY |
| K080948 |
09/26/2008 |
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K081744 |
09/09/2008 |
PASCAL SYNTHESIS DELIVERY SYSTEM |
OPTIMEDICA CORPORATION |
JUDY F GORDON |
| K081415 |
09/24/2008 |
DAMON 4CLEAR |
ORMCO CORP. |
Wendy Garman |
| K081994 |
09/12/2008 |
STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
ALAN T SANDIFER |
| K082523 |
09/26/2008 |
OSSTELL ISQ IMPLANT STABILITY METER |
OSSTELL AB |
CHERITA JAMES |
| K081575 |
09/02/2008 |
HU/HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K080594 |
09/03/2008 |
MS SYSTEM (NARROW RIDGE) |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K082004 |
09/26/2008 |
SMOOTHKIT+ |
OSYRIS |
JAOUAD ZEMMOURI |
| K073328 |
09/09/2008 |
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA |
PAIEON, INC. |
RAVIT BARKAMA |
| K082228 |
09/22/2008 |
PLANISIGHT LINASYS |
PATHFINDER THERAPEUTICS, INC. |
JAMES D STEFANSIC |
| K081518 |
09/05/2008 |
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK |
PENTAX MEDICAL COMPANY |
PAUL SILVA |
| K081749 |
09/30/2008 |
AVANTE Z ZIRCONIA (AS)3 BLOCKS |
PENTRON CERAMICS, INC. |
CINDY SALTER |
| K081489 |
09/25/2008 |
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS |
PETER LAZIC GMBH |
FRANZ MENEAN |
| K081601 |
09/04/2008 |
VEO MULTIGAS MONITOR FOR POCKET PC |
PHASEIN AB |
DAVID WEISSBURG |
| K081989 |
09/26/2008 |
MODIFICATION TO FETCH ASPIRATION CATHETER |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K081810 |
09/17/2008 |
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K082636 |
09/25/2008 |
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T |
QUALITY ELECTRODYNAMICS |
|
| K070309 |
09/12/2008 |
NEOSALUS |
QUINNOVA PHARMACEUTICALS |
JEFFREY DAY |
| K081455 |
09/05/2008 |
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 |
RAYNER SURGICAL INC |
ANDREW WELLS |
| K081948 |
09/19/2008 |
RAYPAX SYSTEM |
RAYPAX, INC. |
CHRIS CHUNG |
| K081779 |
09/19/2008 |
GOLOX-93 |
RESPIRONICS, INC. |
ZITA A YURKO |
| K081539 |
09/26/2008 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082443 |
09/26/2008 |
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082444 |
09/30/2008 |
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K081338 |
09/11/2008 |
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP |
Roche Diagnostics |
STEPHANIE GREEMAN |
| K073498 |
09/19/2008 |
LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM |
RUDOLF MEDICAL GMBH + CO. KG |
FRANZ MENEAN |
| K081702 |
09/05/2008 |
CARBOXYLATE CEM, PHOSPHATE CEM |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K080216 |
09/15/2008 |
SUPRAMESH EXTRA |
S. JACKSON, INC. |
NORMAN R ESTRIN |
| K080375 |
09/02/2008 |
RMX PHYSIOLOGICAL DATA RECORDER |
S.L.P. LTD. |
NOAM HADAS |
| K082192 |
09/17/2008 |
INFRARED EAR THERMOMETER, MODEL ET-101A |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K082264 |
09/12/2008 |
CONTURA LUMEN MARKER |
SENORX, INC. |
EBEN GORDON |
| K082352 |
09/25/2008 |
SERIM DISINTEK OPA TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA A RUPCHOCK |
| K081241 |
09/08/2008 |
WEIGAO EMPTY CARTRIDGE SYRINGE |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K080412 |
09/04/2008 |
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) |
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD. |
BRANDON CHOI |
| K081907 |
09/03/2008 |
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K081910 |
09/17/2008 |
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE |
SIAM SEMPERMED CORP. LTD. |
JOHN CALHOUN |
| K082645 |
09/22/2008 |
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K081013 |
09/08/2008 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN |
SIEMENS HEALTHCARE DIAGNOSTICS |
LIBBY WARRINER |
| K081789 |
09/10/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
HELEN M LEE |
| K071455 |
09/11/2008 |
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
MARY SEEGER |
| K081808 |
09/26/2008 |
ACUNAV V ULTRASOUND CATHETER |
SIEMENS MEDICAL SOLUTIONS USA INC. |
SHELLY PEARCE |
| K081226 |
09/12/2008 |
SIMPACT IMPLANT SYSTEM |
SIMPACT LLC |
ALAN LOMBARDO |
| K082516 |
09/17/2008 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS |
SMITH & NEPHEW, INC. |
LAURA SEJNOWSKI |
| K082426 |
09/05/2008 |
RENASYS EZ |
SMITH & NEPHEW, INC. |
LAURA KREJCI |
| K081016 |
09/05/2008 |
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K081440 |
09/12/2008 |
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
BARBARA LAW |
| K082453 |
09/23/2008 |
4CIS SOLAR AND APOLLON SPINE SYSTEMS |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K081774 |
09/12/2008 |
SOLX 790 TITANIUM SAPPHIRE LASER |
SOLX INC. |
DOUG ADAMS |
| K081485 |
09/18/2008 |
SOMNOWATCH |
SOMNOMEDICS GMBH |
CHERITA JAMES |
| K081711 |
09/11/2008 |
LUCENT MAGNUM+ |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K082467 |
09/11/2008 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K082279 |
09/16/2008 |
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K080420 |
09/02/2008 |
RESERT XL HLD HIGH LEVEL DISINFECTANT |
STERIS Corporation |
JOHN R SCOVILLE JR. |
| K082386 |
09/16/2008 |
INREACH PLANNING LAPTOP |
SUPERDIMENSION, LTD. |
MARGARET DEPUYDT |
| K080089 |
09/04/2008 |
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K073478 |
09/03/2008 |
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K073572 |
09/17/2008 |
MATRIX RF APPLICATOR |
SYNERON MEDICAL LTD. |
YONI IGER |
| K081747 |
09/05/2008 |
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K081623 |
09/08/2008 |
SYNTHES RIB FIXATION SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K081568 |
09/02/2008 |
ANTEGRA-T |
SYNTHES SPINE CO.LP |
KIRSTEN STOWELL |
| K082156 |
09/10/2008 |
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213 |
TELEFLEX MEDICAL |
Angela Bouse |
| K082519 |
09/26/2008 |
FINECROSS MG CORONARY MICRO-GUIDE CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K082644 |
09/18/2008 |
GLIDESHEATH |
TERUMO MEDICAL CORP. |
|
| K082736 |
09/24/2008 |
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K082362 |
09/17/2008 |
SURSHIELD SAFETY I.V. CATHETER |
TERUMO MEDICAL CORP. |
EILEEN DORSEY |
| K080700 |
09/26/2008 |
DUOFLO CATHETER |
THERMOPEUTIX INC. |
|
| K082364 |
09/30/2008 |
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR |
TOPCON CORP. |
BARBARA S FANT, PHARM.D. |
| K080775 |
09/10/2008 |
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS |
TOSAMA D.D. |
ANTONIJA VIDENSEK |
| K082494 |
09/12/2008 |
DRAD3000E/RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082596 |
09/23/2008 |
ULTRAEXTEND USWS-900A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K071132 |
09/16/2008 |
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 |
Tosoh BioScience, Inc. |
CHARLES P GILL |
| K081945 |
09/12/2008 |
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K080116 |
09/08/2008 |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K082393 |
09/11/2008 |
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
UNILENS CORP., USA |
ALAN J FRAZER |
| K082469 |
09/26/2008 |
UNITED U2 PATELLA |
UNITED ORTHOPEDIC CORP. |
RUDY CHEN |
| K081883 |
09/24/2008 |
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM |
US SPINE |
RICHARD JANSEN |
| K080776 |
09/09/2008 |
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 |
USOPHTHALMIC, LLC |
AL WEISENBORN |
| K081625 |
09/26/2008 |
FLOWPICC STYLET |
VASONOVA INC. |
SORIN GRUNWALD |
| K082270 |
09/16/2008 |
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K081114 |
09/16/2008 |
G-1 V5 |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K081117 |
09/16/2008 |
G-2 V5 |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K081116 |
09/02/2008 |
G-IVF G5 SERIES |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K081115 |
09/17/2008 |
G-MOPS G5 SERIES |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K082257 |
09/18/2008 |
ZENO AI ECO DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K081374 |
09/09/2008 |
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K082343 |
09/11/2008 |
VASCUTRAK 2, MODELS: V14 AND V18 |
YMED INC. |
THOMAS SCHROEDER |
| K082042 |
09/03/2008 |
GONGDONG DISPOSABLE SHARP CONTAINER |
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
WEIFENG ZHONG |
| K080164 |
09/25/2008 |
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT |
ZIMMER DENTAL INC. |
ERIN MCVEY |
| K081860 |
09/26/2008 |
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS |
ZIMMER, INC. |
TONI KINGSLEY |
| K081850 |
09/25/2008 |
BISQUE ZIRCONIA BLANKS, TYPE BYZ |
ZIRCAR ZIRCONIA, INC. |
STUART R GOLDMAN |
| K081574 |
09/18/2008 |
ZOLL R SERIES |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |
