FDA 510(k) Applications Received During January, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K073697 01/04/2008 TRANSBOND SUPREME ADHESIVE 3M UNITEK L. MARLYN SCHEFF
K083250 11/04/2008 NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS AA NEUROMED CORP. HERMANN DOLKER
K080101 01/14/2008 AAP CANNULATED SCREW AND DARCO HEADED SCREW AAP IMPLANTATE AG MARC SEEGERS
K083225 11/03/2008 FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. SARAH HARRINGTON
K083223 11/05/2008 RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 ABBOTT DIABETES CARE INC. ARUL STERLIN
K080200 01/25/2008 WATER WORKS DOUCHING DEVICE ABBOTT RESEARCH GROUP, INC. ROSINA ROBINSON
K080074 01/11/2008 ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K083419 11/19/2008 ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 ACTHERM, INC. RICHARD HSIEH
K080100 01/14/2008 WATCHHALER ACTIVAERO AMERICA, INC. PAUL DRYDEN
K083425 11/19/2008 FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE ADAPTIVE SPECIALTY, LLC J.D. WEBB
K083354 11/13/2008 FLORASEAL, MODEL FS350D ADHEZION BIOMEDICAL RICHARD JONES
K073712 01/15/2008 SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 ADROIT MEDICAL SYSTEMS, INC. JON R HERMANSON
K083074 11/11/2008 AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT ADVANDX, INC. PAULA E BULGER
K083311 11/10/2008 AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K083495 11/25/2008 MODIFICATION TO: METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K083279 11/07/2008 CALTRIX RESORBABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K083265 11/05/2008 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 AGAMATRIX INC CONNIE HERTEL
K080252 01/31/2008 MODIFICATION TO MAMMAPRINT AGENDIA BV GUIDO BRINK
K080013 01/03/2008 REGISTRATION AND FUSION AGFA HEALTHCARE CORPORATION TOM HOLBROOK
K082080 11/20/2008 ALCO TUBE PLUS ALCOTEST QUEBEC E.J. SMITH
K080073 01/14/2008 S-TEST CREATININE (CRE) ALFA WASSERMANN, INC. DAVID SLAVIN
K080063 01/10/2008 MASS CASUALTY VENTILATOR, MODEL MCV100 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K083385 11/17/2008 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K080176 01/24/2008 ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K083254 11/04/2008 ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K083496 11/25/2008 CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS ALTATEC GMBH LINDA K SCHULZ
K083142 11/26/2008 PICASSO LASER SYSTEM AMD LASERS, LLC MAUREEN O'CONNELL
K080069 01/11/2008 DIMERTEST AMERICAN DIAGNOSTICA, INC. LEIGH AYRES
K080185 01/25/2008 AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K083246 11/04/2008 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 ANDON HEALTH CO.,LTD LIU YI
K083248 11/04/2008 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 ANDON HEALTH CO.,LTD LIU YI
K083247 11/04/2008 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 ANDON HEALTH CO.,LTD LIU YI
K083317 11/13/2008 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 ANDON HEALTH CO.,LTD LIU YI
K083318 11/13/2008 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 ANDON HEALTH CO.,LTD LIU YI
K083319 11/13/2008 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 ANDON HEALTH CO.,LTD LIU YI
K083395 11/19/2008 SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 ANDON HEALTH CO.,LTD LIU YI
K080151 01/22/2008 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 ANGIOSCORE, INC. KARIN J GASTINEAU
K083278 11/07/2008 AVC A/H5N1 FLU TEST ARBOR VITA CORPORTATION LINDA ALLISTER
K073621 01/02/2008 INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT ART OPTICAL CONTACT LENS, INC. MARTIN DALSING
K083370 11/14/2008 D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 ARTEGRAFT, INC. LAURENCE A POTTER
K080111 01/16/2008 ARTHREX COMPRESSION STAPLE ARTHREX, INC. SALLY FOUST
K083435 11/20/2008 ARTHREX UNIVERS II SHOULDER PEGGED GLENOID ARTHREX, INC. SALLY F OUST
K083306 11/10/2008 MODIFICATION TO ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083240 11/03/2008 OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES ARTHROCARE CORP. LAURA N KASPEROWICZ
K080156 01/23/2008 OSSEOSPEED TM PROFILE SYSTEM ASTRA TECH AB LINDA K SCHULZ
K083488 11/25/2008 JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT AUDIFON-USA INC. JANE E PERRONE
K083313 11/10/2008 WILDCAT 7F GUIDEWIRE SUPPORT CATHETER AVINGER, INC. HIMANSHU PATEL
K083222 11/03/2008 AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE DORA
K083460 11/21/2008 DIALOG WITH ADIMEA OPTION B. BRAUN AVITUM AG BONNIE KINCAID, RAC
K080166 01/23/2008 ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 BECKMAN COULTER, INC. JEFFREY L KOLL
K083466 11/24/2008 MD2000A VITAL SIGN MONITOR, MODEL MD2000A BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K083303 11/10/2008 LANDLEX, MODEL: 402X BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K080003 01/02/2008 BINAXNOW G6PD TEST BINAX, INC. ANNE JEPSON
K073626 01/02/2008 BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM BIO-LOGIC SYSTEMS CORP. NICOHL WILDING
K080012 01/03/2008 PLATELIA LYME IGG ASSAY BIO-RAD FRAN WHITE
K080008 01/02/2008 BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET BIO-RAD LABORATORIES, INC. CYNTHIA SINCLAIR
K083274 11/06/2008 WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER BIOCOMPATIBLES, INC. WAYNE RICHARDSON
K080210 01/28/2008 PRO QR ADVANCED FORMULA POWDER BIOLIFE, LLC KAREN O'TOOLE
K083536 11/28/2008 DENSICHEK PLUS BIOMERIEUX, INC. JOLYN TENLLADO
K080017 01/03/2008 VIDAS AFP ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K080194 01/25/2008 VIDAS CEA (S) ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K080107 01/15/2008 VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM BIOMERIEUX, INC. NANCY WEAVER
K083383 11/18/2008 VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K080201 01/28/2008 VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC. JOLYN TENLLADO
K080088 01/14/2008 BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS BIOMET MANUFACTURING, INC. ROBERT R FRIDDLE
K080204 01/28/2008 VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS BIOMET, INC. GARY BAKER
K083490 11/25/2008 BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 BIOPRO, INC. DAVID MRAK
K083384 11/17/2008 THERMODILUTION CATHETER BIOSENSORS INTL. PTE. LTD. MOSES THAM
K083355 11/13/2008 WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 BLAIREX LABORATORIES, INC. CAREY BOTTOM
K083374 11/13/2008 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K083420 11/19/2008 MEDONIC M SERIES BOULE MEDICAL AB MICHAEL ELLIOTT
K083372 11/17/2008 ARROWBONE-A, ARROWBONE-B BRAINBASE CORPORATION H. NEAL DUNNING
K083483 11/24/2008 BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED BRAINLAB AG MICHAEL HOTTNER
K083310 11/10/2008 SPINE & TRAUMA ICT BRAINLAB AG RAINER BIRKENBACH
K083424 11/19/2008 BUSSE SURGICAL DRAPE BUSSE HOSIPITAL DISPOSABLES MUHAMAD ANSARI
K083417 11/18/2008 INTRATEMP SOLUTION WARMER C CHANGE SURGICAL LLC PATRICK KAMMER
K080170 01/24/2008 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) C.R. BARD, INC. SKIP RIMER
K080023 01/04/2008 MODIFICATION TO: SPIRIT CAIRE, INC. ZULFIQAR A CHOUDARY
K083174 11/05/2008 HEALTHEPOD CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K080154 01/23/2008 ACUITY UNIVERSAL CUTTER CARDIAC PACEMAKERS, INC. KATHLEEN VITTUM
K080174 01/28/2008 PHLEBOTOMY BAG WITH VALVE & 17G X 1", MODEL CM-PH17X1B, CM-PH17X1C CARDIOMED SUPPLIES, INC. CHRISTIAN G DUBE
K083291 11/07/2008 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K080076 01/11/2008 RX DC X-RAY UNIT CEFLA S.C.R.L. CLAUDE BERTOIN
K080084 01/14/2008 CELL GEN LASER, MODEL CG-4000 CELL GEN THERAPEUTICS, LLC DICK RIVERA
K083433 11/20/2008 INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 CHATTANOOGA GROUP MICHAEL TREAS
K080105 01/15/2008 ENDOTRACHEAL TUBE CHILECOM MEDICAL DEVICES CO., LTD. BRANDON CHOI
K080196 01/25/2008 Z3D CONTRAST ACUITY CLARIO MEDICAL IMAGING, INC. CHRIS WOOD
K083499 11/25/2008 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS COLOPLAST A/S JANELL A COLLEY
K083304 11/10/2008 TEMPOSIL 2 COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K083224 11/03/2008 CPI RAD VISION, MODEL VZW2944XX-YY COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K083331 11/17/2008 CONFIDANT, MODEL 2.6 CONFIDANT INC. DANIEL R PLONSKI
K083448 11/21/2008 CABLE, TRANSDUCER, MODEL 2400GN CONMED CORPORATION SARAH RIZK
K083330 11/12/2008 ECHOTIP ULTRA ULTRASOUND NEEDLE COOK ENDOSCOPY SCOTTIE FARIOLE
K083482 11/24/2008 COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET COOK VASCULAR INC. JIM FERGUSON, JR.
K080037 01/08/2008 MODIFICATION TO ZILVER 635 BILIARY STENT COOK, INC. STEPHANIE ROBERTS
K083312 11/10/2008 MINIHIP STEM CORIN U.S.A. ASHLEA BOWEN
K083287 11/07/2008 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM CORVENTIS, INC. DAWN CHANG
K072814 01/04/2008 CONVENIENCE KIT FOR "SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES" COVIDIEN ROBERT ZOTT
K083325 11/12/2008 N-600X WITH SPD, OXIMAX N-600X COVIDIEN SCOTT D DICKERHOFF
K083350 11/13/2008 TENS/NMES/FES STIMULATING ELECTRODE COVIDIEN LP WEI ZHAO
K083321 11/11/2008 CARDIO-VIEW CURLVIEW IGT, LLC
K080006 01/02/2008 AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE CYNOSURE, INC. GEORGE CHO
K083379 11/14/2008 CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE CYNOSURE, INC. GEORGE CHO
K080121 01/17/2008 CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER CYNOSURE, INC. GEORGE CHO
K073587 01/02/2008 DERMAPAL WITH DIGITAL TIMER DAAVLIN DISTRIBUTING CO. TARA MANSUR
K080114 01/17/2008 HUAYI H035 BASIC WHEELCHAIR DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD NORMAN F ESTRIN
K073483 01/10/2008 SAPPHIRE O/E ORAL EXAMINATION SYSTEM DEN-MAT HOLDINGS, LLC ALAN MATTHEWS
K083398 11/17/2008 CERCOM CEMENT DENALI R&D CORPORATION JAN G STANNARD
K083473 11/24/2008 CLEAR BRAVO DENALI R&D CORPORATION JAN STANNARD
K083543 11/28/2008 DENOVISMED DENTAL IMPLANT SYSTEMS DENOVIS MEDICAL, LLC KEVIN A THOMAS
K083252 11/04/2008 NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM DENTALEZ GROUP, STARDENTAL DIVISION DALE BRAAS
K083400 11/17/2008 CUSTOM COMFORT NIGHTGUARD DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K083326 11/12/2008 FLUOROCORE 2 DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K080246 01/31/2008 COMPOSITE ALIGNER BUTTON DENTSPLY INTERNTIONAL HELEN LEWIS
K080203 01/28/2008 MTA ROOT CANAL SEALER DENTSPLY INTERNTIONAL HELEN LEWIS
K083364 11/13/2008 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K073413 01/04/2008 DEPUY ASR 300 ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K073676 01/02/2008 DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K080191 01/25/2008 EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. FRANK S JURCZAK
K083532 11/28/2008 ADX4000-L, DX3000-L DEXCOWIN CO., LTD CLAUDE YANG
K083391 11/17/2008 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K080005 01/02/2008 SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 DING HWA CO., LTD. HUI-CHEN KAI
K080126 01/17/2008 DIO PROTEM IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. HYUNGICK KIM
K080129 01/17/2008 SECURE IMPLANT SYSTEM (2.5/3.0MM) DIO DEPARTMENT DSI, INC. HYUNGICK KIM
K080128 01/17/2008 SM-EXTRA WIDE (RBM) IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. HYUNGICK KIM
K083258 11/04/2008 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC. THERON GOBER
K083500 11/25/2008 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC. THERON GOBER
K080064 01/10/2008 FLAATZ 750 DRTECH CORP. BEOM-JIN MOON
K083320 11/12/2008 DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE DUKAL CORP. JIM VILARDI
K080036 01/07/2008 PORTABLE ECSCOPE 12I DYANSYS, INC. SRINI NAGESHWAR
K080087 01/23/2008 SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR EDAN INSTRUMENTS, INC. WILLIAM STERN
K083470 11/24/2008 CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 EDWARDS LIFESCIENCES, LLC. ERICA WALTERS
K073616 01/03/2008 FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE ELECTROMEDICS CO. LTD. JOHN SCHOLZ
K080250 01/31/2008 LEKSELL SURGIPLAN, MODEL 1006947 ELEKTA INSTRUMENT AB PETER LOWENDAHL
K083478 11/24/2008 SMOOTHLIPO ELEME MEDICAL, INC. MICHAIL PANKRATOV, MD
K080075 01/11/2008 MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD. CHARISE DE BARROS
K073682 01/02/2008 EMBLETTA GOLD EMBLA SYSTEMS, INC. ROBERT G SCHUEPPERT
K083292 11/10/2008 HABIB ENDOHPB EMCISION, LTD. NAGY HABIB
K080258 01/31/2008 MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM ENDIUS, INC. REGINA WAGNER
K083461 11/25/2008 IMAGINE TC SKIN THERAPY SYSTEM ENDYMION MEDICAL LTD YORAM LEVY
K080032 01/08/2008 ENVOYCEM, MODEL 1640 ENVOY MEDICAL CORPORATION BERNARD (BUD) HORWATH
K080146 01/23/2008 ZIRKONDENT ERGOMETA MIKE ARTEMOV
K080102 01/30/2008 TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM ESCADA INTERNATIONAL, INC. KEVIN WALLS
K080049 01/08/2008 VASCUVIEW ULTRASOUND SYSTEM ESCALON MEDICAL CORP. MARK WALLACE
K080119 01/17/2008 CLEARSCAN ESI, INC. GEORGE MYERS
K082124 11/21/2008 CARDITTE MICROTEL ET MEDICAL DEVICES SPA LUIGI BUCCHI
K083381 11/14/2008 EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K083342 11/12/2008 ORBITAL RECONSTRUCTIVE IMPLANT II EVERA MEDICAL, INC. RANDY KESTEN
K083302 11/10/2008 LIFECARE ELECTRODES EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K083392 11/17/2008 NOVATION 12/14 CEMENTED FEMORAL STEMS EXACTECH, INC. GRAHAM L CUTHBERT
K083508 11/26/2008 SWABCAP EXCELSIOR MEDICAL CORP. ROSHANA AHMED
K083428 11/19/2008 F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY FIAB SPA SILVIA CALABRO
K080209 01/28/2008 FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. TINA MASON
K083347 11/13/2008 IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS FLUKE BIOMEDICAL COLLEEN BOSWELL
K083542 11/28/2008 FRESENIUS STERILE STAY SAFE CAP FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K080039 01/08/2008 PASSIVE WASTE GAS SCAVENGER, MODEL 14600 G. DUNDAS CO.,INC. MARIO SORCI
K083504 11/26/2008 GE DISCOVERY NM/CT 570C GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K080124 01/17/2008 VENTRI 1.1 GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K080251 01/31/2008 APEXPRO TELEMETRY SYSTEMS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES BERNARD SANDLER
K080157 01/23/2008 DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SHARON UNTZ
K083421 11/19/2008 MR-TOUCH OPTION GE MEDICAL SYSTEMS, LLC DANIEL BIANK
K083471 11/24/2008 GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 GENERIC MEDICAL DEVICE, INC. MONICA MONTANEZ
K080117 01/18/2008 PATIENT ISOLATION UNIT, MODEL G019-1000 GENTEX CORPORATION BARRY SHOPE
K083509 11/26/2008 LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA GENX INTL., INC. MICHAEL D CECCHI
K083272 11/06/2008 SKINCLEAR Q-SWITCHED ND:YAG LASER GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K083389 11/17/2008 COALITION SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K083232 11/03/2008 MODIFICATION TO:MICROFUSE BONE VOID FILLER GLOBUS MEDICAL INC. KELLY J BAKER
K083442 11/20/2008 CORRIDOR FIXATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K083416 11/18/2008 REVOLVE STABILIZATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K083399 11/19/2008 ICS CHARTR EP 200 GN OTOMETRICS A/S DAN SANSONETTI
K080070 01/31/2008 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES GRACE MEDICAL, INC. JEFF COBB
K083479 11/24/2008 BIOCRYL X GREAT LAKES ORTHODONTICS, LTD. MARK LAUREN
K080235 01/30/2008 SAFETY INFUSION SET GREINER BIO-ONE VACUETTE NORTH AMERICA JUDITH SMITH
K080169 01/24/2008 HEARTSTRING III PROXIMAL SEAL SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY ELIZABETH TRUJILLO
K080025 01/04/2008 LED.L, LED.M, LED.G, LED.B GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD CHARLIE MACK
K080066 01/10/2008 VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) GX CORPORATION SDN BHD FOO KHON PU
K080093 01/14/2008 PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK GYRUS ACMI, INC. TERRENCE E SULLIVAN
K080181 01/24/2008 MODIFICATION TO GALILEO GOLD HAMILTON MEDICAL AG JOERG SCHNEIDER
K080019 01/03/2008 HARDYDISK AST DORIPENEM 10 UG HARDY DIAGNOSTICS WENDY PHILLIPS
K083457 11/21/2008 TACTIPEN HASELMEIER GMBH STEPHEN J GOLDNER, JD, RAC
K080091 01/14/2008 MODIFICATION TO:HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. ROBIN BUSH SAWAMURA
K080242 01/31/2008 HEARTWAY POWER MOBILITY SCOOTER, PF7 HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K080221 01/29/2008 EA STIMULATOR HELIO MEDICAL SUPPLIES, INC. YUKUO HSO
K080226 01/29/2008 NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 HILL-ROM MANUFACTURING, INC. DAWN M REILLY
K083533 11/28/2008 ECHELON C MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEHWAITE
K080062 01/09/2008 OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K083534 11/28/2008 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. NANCY GERTLAR
K083437 11/20/2008 MODIFICATION TO T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. AVITAL MERL-MARGULIES
K083468 11/24/2008 CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) I-SENS, INC. HYUN JOON OH
K080184 01/25/2008 DISTAL HUMERAL PLATES WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINOCOTT
K080077 01/15/2008 CLAVE STOPCOCK ICU MEDICAL, INC TRACY BEST
K080007 01/02/2008 GRADUATED ADAPTER WITH CLAVE ICU MEDICAL, INC TRACY BEST
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K080020 01/03/2008 ARCOFIX SYNTHES SPINE CO.LP KIRSTEN STOWELL
K080014 01/03/2008 CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION YUHUA CHEN
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K083440 11/20/2008 PRIMATRIX DERMAL REPAIR SCAFFOLD TEI BIOSCIENCES INC. KENNETH JAMES
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K080234 01/30/2008 TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO TERATECH CORP.
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K083194 11/05/2008 VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550 TERUMO CARDIOVASCULAR SYSTEMS CORP. JUNKO KUROSAWA
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K083512 11/26/2008 FLUID-FILLED TEETHER WILTEC INDUSTRIES LTD. KEVIN WALLS
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K080071 01/11/2008 SIDEKICK RAIL FIXATOR WRIGHT MEDICAL TECHNOLOGY, INC. PEGGY S RIVERS
K083270 11/06/2008 WMT COMPOSITE DBM WRIGHT MEDICAL TECHNOLOGY, INC. RYAN M BELANEY
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K083324 11/12/2008 LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM ZEST ANCHORS, INC. RICHARD A OVERTON
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