| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K081325 |
05/12/2008 |
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML |
AB BIODISK |
ANETTE ENGELHARDT |
| K081231 |
05/01/2008 |
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 |
ABBOTT LABORATORIES |
CAROL JOCHUM |
| K081495 |
05/29/2008 |
CELL-DYN EMERALD SYSTEM |
ABBOTT LABORATORIES |
MICHELLE B ROEDING |
| K081417 |
05/20/2008 |
FOXCROSS PTA CATHETER |
ABBOTT VASCULAR INC. |
NADINE SMITH |
| K081398 |
05/19/2008 |
ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES |
ADVANCED MEDICAL INNOVATIONS, INC. |
MARIA F GRIFFIN |
| K081363 |
05/15/2008 |
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K081309 |
05/09/2008 |
E.COLI/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K081433 |
05/21/2008 |
EK/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K081293 |
05/07/2008 |
UNIVATION UNICONDYLAR KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K081251 |
05/02/2008 |
MODIFICATION TO AESKULISA DS DNA G |
AESKU.DIAGNOSTICS |
SASCHA PFEIFFER |
| K081304 |
05/08/2008 |
ALZ WEB PACS, VERSION 1.0 |
ALZ, INC. |
CYNTHIA NOLTE |
| K081472 |
05/27/2008 |
SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS |
ANGIODYNAMICS, INC. |
BRIAN KUNST |
| K081312 |
05/09/2008 |
ARAGON ONESHOT SYSTEM |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K081497 |
05/29/2008 |
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K081329 |
05/12/2008 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K081238 |
05/01/2008 |
REPROCESSED MASIMO PULSE OXIMETER SENSORS |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K081323 |
05/12/2008 |
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 |
B-K MEDICAL APS |
JENS RASMUSSEN |
| K081289 |
05/07/2008 |
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K081446 |
05/22/2008 |
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
| K081522 |
05/30/2008 |
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY |
BIO NUCLEAR DIAGNOSTICS, INC. |
SURENDER CHOUDHRY |
| K081362 |
05/15/2008 |
PLATELIA LYME IGM |
BIO-RAD |
FRAN WHITE |
| K081499 |
05/29/2008 |
HEALTH MANAGER, VERSION 1.1 |
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
MARION OTTO |
| K081498 |
05/29/2008 |
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 |
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
Martin Gabler |
| K081428 |
05/21/2008 |
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K081501 |
05/29/2008 |
SOLITAIRE ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K081395 |
05/19/2008 |
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K081243 |
05/01/2008 |
BIOMET PHOENIX ANKLE NAIL SYSTEM |
BIOMET TRAUMA |
SUSAN ALEXANDER |
| K081244 |
05/01/2008 |
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS |
BIOMET TRAUMA |
PATRICIA S BERES |
| K081451 |
05/23/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K081450 |
05/23/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 |
BIONIME CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K081403 |
05/19/2008 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK |
BIONOSTICS, INC. |
RANDY BYRD |
| K081478 |
05/27/2008 |
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K081392 |
05/19/2008 |
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K081258 |
05/02/2008 |
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
| K081372 |
05/16/2008 |
GELX ORAL GEL |
BMG PHARMA LLC. |
WILLIAM A GOOLSBEE |
| K081275 |
05/05/2008 |
BOSTON SCIENTIFIC SURGICAL MESH |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K081431 |
05/21/2008 |
MEG LAPAROSCOPIC ELECTRODES |
BOVIE MEDICAL |
RICHARD KOZLOFF |
| K081444 |
05/22/2008 |
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM |
BRAEMAR, INC. |
DARREN DERSHEM |
| K081272 |
05/05/2008 |
PORCINE SURGICAL MESH; DERMAL MATRIX |
BRENNEN MEDICAL, LLC |
KENNETH B HERLAND |
| K081288 |
05/07/2008 |
ASPIRA PERITONEAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
| K081311 |
05/09/2008 |
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER |
C.R. BARD, INC. |
JIHYUN KIM |
| K081253 |
05/02/2008 |
ZIRDENT CAD/CAM BLOCKS |
C5 MEDICAL WERKS, INC. |
HOMER GREGORY |
| K081324 |
05/12/2008 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS |
CANDELA CORP. |
LISA LACROIX |
| K081257 |
05/02/2008 |
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K081464 |
05/27/2008 |
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES |
Cardinal Health |
STEVE TAMSETT |
| K081264 |
05/05/2008 |
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 |
CHILDREN'S HEALTH FIRST, INC. |
ROGER T VAUGHAN |
| K081255 |
05/02/2008 |
SCRAMBLER ST 5 TENS DEVICE |
COMPETITIVE TECHNOLOGIES,INC. |
MARY MCNAMARA |
| K081305 |
05/08/2008 |
MERCI RETRIEVER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K081337 |
05/13/2008 |
APPROACH CTO WIRE GUIDE |
COOK INCORPORATED |
KAREN BRADBURN |
| K081425 |
05/21/2008 |
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT |
COOK VASCULAR, INC. |
JIM FERGUSON |
| K081237 |
05/01/2008 |
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT |
CRAFTMASTER CONTOUR EQUIPMENT, INC. |
STUART R GOLDMAN |
| K081424 |
05/20/2008 |
AFFIRM CO2 AND AFFIRM CO2 HP |
CYNOSURE, INC. |
GEORGE CHO |
| K081249 |
05/02/2008 |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
DADE BEHRING, INC. |
ANNA MARIE KATHLEEN ENNIS |
| K081413 |
05/20/2008 |
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM |
DAILIAN LATEX COMPANY, LTD. |
|
| K081286 |
05/07/2008 |
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 |
DAKO NORTH AMERICA, INC. |
KELLY MILLER |
| K081259 |
05/02/2008 |
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
DEFIBTECH, LLC |
Ed Horton |
| K081287 |
05/07/2008 |
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT |
DEN-MAT HOLDINGS, LLC |
ALAN MATTHEWS |
| K081291 |
05/07/2008 |
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K081252 |
05/02/2008 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K081432 |
05/21/2008 |
HEALOS II BONE GRAFT SUBSTITUTE |
DEPUY SPINE, INC. |
HANDE TUFAN |
| K081493 |
05/28/2008 |
INFILTRATION KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K081405 |
05/19/2008 |
XERACEM |
DOXA DENTAL AB |
JONATHAN KAHAN |
| K081447 |
05/22/2008 |
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO |
DRAEGER MEDICAL AG & CO. KG |
KARIN LUEBBERS |
| K081382 |
05/16/2008 |
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K081385 |
05/16/2008 |
URESTA PESSARY |
EASTMED INC. |
SHIRLEY FURESZ |
| K081357 |
05/14/2008 |
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) |
EIZO GMBH |
JAMES BERGE |
| K081467 |
05/27/2008 |
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION |
EKOS CORP. |
JOCELYN KERSTEN |
| K081430 |
05/21/2008 |
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING |
ELEKTA NEUROMAG OY |
DANIEL KAMM |
| K081408 |
05/19/2008 |
ELLIPSE MULTIFLEX |
ELLIPSE A/S |
OLE KOFOD |
| K081448 |
05/23/2008 |
ENCORE SHOULDER REVISION GLENOID |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K081400 |
05/19/2008 |
FANNING-PAPPAS MODULAR KNEE BEARING |
ENDOTEC, INC. |
MICHAEL PAPPAS |
| K081394 |
05/19/2008 |
PTFE INTERLOCK PEELABLE INTRODUCERS |
ENPATH MEDICAL, INC. |
SHANNON SPRINGER |
| K081386 |
05/19/2008 |
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) |
ESAOTE S.P.A. |
Allison Scott |
| K081274 |
05/05/2008 |
SURESKIN SILVER BANDAGES |
EUROMED, INC. |
SUBHASH CHANDER |
| K081308 |
05/09/2008 |
FUJIFILM FCR VIEW, MODEL CR-VW674 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBRA A PEACOCK |
| K081393 |
05/19/2008 |
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW |
G & H WIRE CO. |
CARRI GRAHAM |
| K081437 |
05/22/2008 |
MAC 1600 ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MARGARET MUCHA |
| K081496 |
05/29/2008 |
OPTIMA PET/CT 560 |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K081391 |
05/19/2008 |
VIP ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K081234 |
05/01/2008 |
GN OTOMETRICS INSERT EARPHONES |
GN OTOMETRICS |
DANIEL SANSONETTI |
| K081315 |
05/09/2008 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT) |
GX CORPORATION SDN BHD |
FOO K PU |
| K081263 |
05/05/2008 |
STARCERAM |
H.C. STARCK CERAMICS GMBH & CO.KG |
ROBERT N CLARK |
| K081521 |
05/30/2008 |
MODIFICATION TO HAMILTON-G5 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K081442 |
05/22/2008 |
HEART SYNC PEDIATRIC, MODEL PED-100 |
HEART SYNC LLC |
STEPHEN SHULMAN |
| K081327 |
05/12/2008 |
RELIMESH |
HERNIAMESH S.R.L. |
LORENA TRABUCCO |
| K081276 |
05/05/2008 |
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H |
HORIBA ABX |
OLIVIER DUCAMP |
| K081412 |
05/20/2008 |
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
HOSPIRA, INC. |
DANIELA WEKSLER |
| K081278 |
05/06/2008 |
OMEGA 3 TROCHANTERIC STABILIZING PLATE |
HOWMEDICA OSTEONICS CORP. |
ANDREA DWYER |
| K081284 |
05/06/2008 |
VARIAX DISTAL FIBULA PLATE |
HOWMEDICA OSTEONICS CORP. |
ANDREA M DWYER |
| K081346 |
05/14/2008 |
HOYA IS INJECTOR SYSTEM |
HOYA SURGICAL OPTICS, INC. |
STEVEN L ZIEMBA |
| K081506 |
05/29/2008 |
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS |
HYPERBARIC AMERICA, LLC |
TOM WORKMAN |
| K081361 |
05/15/2008 |
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX |
ICU MEDICAL INC |
TRACY BEST |
| K081396 |
05/19/2008 |
SWISSPLANT DENTAL IMPLANT SYSTEM |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K081347 |
05/14/2008 |
ILUMA VISION |
IMTEC CORP. |
BRAD VANCE |
| K081248 |
05/02/2008 |
QUANTA LITE OMP PLUS ELISA |
INOVA DIAGNOSTICS, INC. |
ZAKERA SHUMS |
| K081419 |
05/20/2008 |
STRAUMANN DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
LISA QUAGLIA |
| K081401 |
05/19/2008 |
MAYFIELD MR/X-RAY SKULL CLAMP |
INTEGRA LIFESCIENCES CORP. |
HELDER A SOUSA |
| K081477 |
05/27/2008 |
LUXTEC MLX LIGHT SOURCE |
INTEGRA LUXTEC, INC. |
RITA WADLEIGH |
| K081459 |
05/23/2008 |
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K081399 |
05/19/2008 |
AVIATOR TRANSPORT INCUBATOR |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K081436 |
05/21/2008 |
INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES |
INVIRO MEDICAL DEVICES, INC. |
ROBERT N CLARK |
| K081262 |
05/05/2008 |
DC NEURO |
INVIVO CORPORATION |
THEODORE J REISKER |
| K081471 |
05/27/2008 |
ECARD AND CCARD |
IRHYTHM TECHNOLOGIES, INC. |
WILLIAM H RIGHTER |
| K081247 |
05/01/2008 |
TM-400 |
ITO CO., LTD. |
KENNETH L BLOCK |
| K081381 |
05/16/2008 |
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K081380 |
05/16/2008 |
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K081267 |
05/05/2008 |
HYGEIA-5 OXYGEN CONCENTRATOR |
KEDL INTERNATION LIMITED |
Lee Leichter |
| K081260 |
05/02/2008 |
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES |
KIMBERLY-CLARK CORP. |
RICHARD V WOLFE |
| K081514 |
05/30/2008 |
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER |
LANG DENTAL MFG. CO., INC. |
CHAH M SHEN |
| K081371 |
05/15/2008 |
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K081438 |
05/22/2008 |
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT |
LifeNet Health |
ALYCE LINTHURST JONES |
| K081318 |
05/12/2008 |
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM |
LIFESCAN, INC. |
FRANK PERALTA |
| K081483 |
05/28/2008 |
XTAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K081402 |
05/19/2008 |
SIMPLANT ORTHO ; VISTADENT 3D |
MATERIALISE DENTAL NV |
CARL VAN LIERDE |
| K081236 |
05/01/2008 |
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME |
MCNEIL-PPC, INC. |
NADER FOTOUHI |
| K081269 |
05/05/2008 |
AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
| K081463 |
05/23/2008 |
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP |
MEDEL S.P.A. |
TERRENCE O'BRIEN |
| K081505 |
05/29/2008 |
THERAGEM PROFESSIONAL T1002 |
MEDICA HEALTH, LTD |
TERRI CMOREY |
| K081473 |
05/27/2008 |
HERO, VERSION 2.0 |
MEDICAL PREDICTIVE SCIENCE CORP. |
WILLIAM E KING |
| K081457 |
05/23/2008 |
ATRILAZE LASER ABLATION SYSTEM |
MEDICALCV, INC. |
KIRK S HONOUR |
| K081355 |
05/14/2008 |
BIOFLEX LD-R100 TREATMENT HEAD |
MEDITECH INTERNATIONAL, INC. |
FRED KAHN |
| K081516 |
05/30/2008 |
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT |
MEDSOURCE INTERNATIONAL, LLC. |
|
| K081512 |
05/30/2008 |
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE |
MEDTRONIC NAVIGATION, INC. |
KEVIN MORNINGSTAR |
| K081297 |
05/07/2008 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K081475 |
05/27/2008 |
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
| K081277 |
05/05/2008 |
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
| K081302 |
05/08/2008 |
RESCUE EXTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
JUNG B BANG |
| K081443 |
05/22/2008 |
MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K081484 |
05/28/2008 |
HORIZON XVU |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K081266 |
05/05/2008 |
MERCURY MEDICAL PEEP VALVE |
MERCURY ENTERPRIZES DBA MERCURY MEDICAL |
BRIAN L MORRISON |
| K081513 |
05/30/2008 |
MERETE 3.0 AND 3.5 MM LOCKING SCREWS |
MERETE MEDICAL GMBH |
JORG MIETZNER |
| K081465 |
05/27/2008 |
AXIUM DETACHABLE COIL SYSTEM |
MICRO THERAPEUTICS, INC. |
NEELU MEDHEKAR |
| K081268 |
05/05/2008 |
SONIC AIR MM1500 + (MID), MODEL 50400014 |
MICRO-MEGA SOCIETE ANONYME |
ISABELLE BOURG |
| K081360 |
05/15/2008 |
PATHFAST CK-MB-II, PATHFAST MYO-II |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
| K081509 |
05/29/2008 |
MONTERIS MEDICAL AUTOLITT LASER PROBE |
MONTERIS MEDICAL |
CRAIG COOMBS |
| K081356 |
05/14/2008 |
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM |
MYLAD ORTHOPEDIC SOLUTIONS, LLC |
SCOTT EDWARDS |
| K081366 |
05/15/2008 |
KUMAR T-ANCHORS HERNIA SET |
NASHVILLE SURGICAL INSTRUMENTS |
SARBJEET KUMAR |
| K081503 |
05/29/2008 |
AED MONOPOLAR LAP ACCESSORIES |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K081480 |
05/27/2008 |
KEGEL8 PELVIC EXERCISER, MODEL OPH 400 |
NE SERVICES LTD. |
BRENT REIDER |
| K081515 |
05/30/2008 |
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 |
NEOMED, INC. |
PENNY NORTHCUTT |
| K081285 |
05/06/2008 |
FINGER PULSE OXIMETER, MODEL 9560 |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K081281 |
05/06/2008 |
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K081377 |
05/16/2008 |
NUVASIVE SURGICAL MESH SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K081330 |
05/12/2008 |
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) |
O-TWO MEDICAL TECHNOLOGIES, INC. |
PAUL DRYDEN |
| K081456 |
05/23/2008 |
OLYMPUS CHF TYPE V |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K081415 |
05/20/2008 |
DAMON 4CLEAR |
ORMCO CORP. |
Wendy Garman |
| K081411 |
05/20/2008 |
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K081407 |
05/19/2008 |
ORTHOPEDIATRICS PEDIPLATES SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K081439 |
05/22/2008 |
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
DAVID J MCILHENNY |
| K081416 |
05/20/2008 |
PALOMAR ASPIRE LASER PLATFORM |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K081328 |
05/12/2008 |
PATHWAY PV ATHERECTOMY SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K081518 |
05/30/2008 |
ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK |
PENTAX MEDICAL COMPANY |
PAUL SILVA |
| K081489 |
05/28/2008 |
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS |
PETER LAZIC GMBH |
FRANZ MENEAN |
| K081426 |
05/21/2008 |
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MELINDA NOVATNY |
| K081307 |
05/08/2008 |
OMNILUX CLEAR-U |
PHOTO THERAPEUTICS, INC. |
SUE DARCY |
| K081454 |
05/23/2008 |
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K081460 |
05/23/2008 |
TDS ABUTMENT |
POU YU BIOTECHNOLOGY CO., LTD. |
LINDA K SCHULZ |
| K081232 |
05/01/2008 |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES |
PRAXIM |
ANNIE POLLIER |
| K081388 |
05/19/2008 |
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM |
PRONIA MEDICAL SYSTEM, LLC |
CYNTHIA J.M. NOLTE |
| K081488 |
05/28/2008 |
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
PT. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K081455 |
05/23/2008 |
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 |
RAYNER SURGICAL INC |
ANDREW WELLS |
| K081383 |
05/16/2008 |
RELIANCE VBS SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K081321 |
05/12/2008 |
MODIFICATION TO MIRAGE MICRO |
RESMED LTD. |
DAVID D'CRUZ |
| K081420 |
05/20/2008 |
VANISHPOINT I.V. CATHETER |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K081410 |
05/20/2008 |
OPTION VENA CAVA FILTER |
REX MEDICAL |
LEO BASTA |
| K081256 |
05/02/2008 |
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H |
RIO FLEXON TECHNOLOGY CO., LTD. |
CHI-HUNG LIAO |
| K081389 |
05/19/2008 |
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
Scott Thiel |
| K081338 |
05/13/2008 |
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP |
Roche Diagnostics |
STEPHANIE GREEMAN |
| K081352 |
05/14/2008 |
PROFILE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K081359 |
05/15/2008 |
GENESIS ECP |
SCOTTCARE CORPORATION |
RONALD J CLINES |
| K081273 |
05/05/2008 |
ULTRACAPS S |
SDI LTD. |
RAY CAHILL |
| K081469 |
05/27/2008 |
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 |
SECTRA IMTEC AB |
CARL ALLETO |
| K081370 |
05/15/2008 |
SERIM DISINTEK OPA TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K081241 |
05/01/2008 |
WEIGAO EMPTY CARTRIDGE SYRINGE |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K081322 |
05/12/2008 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
CHARLES MACK |
| K081340 |
05/13/2008 |
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
CHARLES MACK |
| K081508 |
05/29/2008 |
HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN |
SHENYANG CANTA MEDICAL TECH CO., LTD. |
Diana Hong |
| K081320 |
05/12/2008 |
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K081300 |
05/08/2008 |
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
PAMELA A JURGA |
| K081294 |
05/07/2008 |
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS |
Siemens Healthcare Diagnostics Inc. |
PHILIP LIU |
| K081319 |
05/12/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 |
Siemens Healthcare Diagnostics Inc. |
GEORGE M PLUMMER |
| K081299 |
05/08/2008 |
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA |
Siemens Healthcare Diagnostics Inc. |
RADAMES RIESGO |
| K081453 |
05/23/2008 |
BIOGRAPH HD FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K081332 |
05/12/2008 |
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K081466 |
05/27/2008 |
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K081511 |
05/29/2008 |
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K081351 |
05/14/2008 |
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT |
SMITH & NEPHEW, INC. |
NICHOLAS B TABRIZI |
| K081491 |
05/28/2008 |
SMITH & NEPHEW CDS SYSTEM |
SMITH & NEPHEW, INC. |
MASON W ROBBINS |
| K081440 |
05/22/2008 |
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
BARBARA LAW |
| K081485 |
05/28/2008 |
SOMNOWATCH |
SOMNOMEDICS GMBH |
CHERITA JAMES |
| K081313 |
05/09/2008 |
SH14 HEMOCONCENTRATOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K081233 |
05/01/2008 |
T-STAT 303 ISCHEMIA MONITORING SYSTEM |
SPECTROS CORPORATION |
BILL CURNAN |
| K081240 |
05/01/2008 |
TIGER DISCECTOMY DEVICE |
SPINAL DEVICES, LLC |
RICHARD JANSEN |
| K081418 |
05/20/2008 |
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K081404 |
05/19/2008 |
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT |
SPINAL INTEGRATION LLC |
TRUDIE L SEEGER |
| K081331 |
05/12/2008 |
FIXXSURE CROSS LINK |
SPINEWORKS, LLC |
J.D. WEBB |
| K081406 |
05/19/2008 |
SNAP WOUND CARE DEVICE |
SPIRACUR, INC. |
JANICE M HOGAN |
| K081365 |
05/15/2008 |
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR |
ST. JUDE MEDICAL |
ELIZABETH E NEELY |
| K081458 |
05/23/2008 |
PROVEN STEM EXTENDER |
STELKAST COMPANY |
DONALD A STEVENS |
| K081342 |
05/13/2008 |
REPROCESSED EXTERNAL FIXATION ACCESSORIES |
STERILMED, INC. |
JOSHUA CLARIN |
| K081427 |
05/21/2008 |
BROWNE OPA TEST STRIP |
STERIS Corporation |
ROBERT SULLIVAN |
| K081468 |
05/27/2008 |
DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K081379 |
05/16/2008 |
MODIFICATION TO INREACH SYSTEM |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
| K081476 |
05/27/2008 |
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE |
SURGICAL CONCEPT DESIGNS |
CHRISTOPHER SCOTT |
| K081452 |
05/23/2008 |
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM |
SYNTHES (USA) |
JILL R SHERMAN |
| K081353 |
05/14/2008 |
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K081445 |
05/22/2008 |
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B |
TaiDoc Technology Corporation |
Yuhua Chen |
| K081390 |
05/19/2008 |
BIOACTIF OSTEOTRANS INTERFENCE SCREW |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K081335 |
05/12/2008 |
TENACORE OXYGEN BLENDER, MODEL TB-2000 |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K081265 |
05/05/2008 |
THAI NIPPON MALE LATEX CONDOM |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
| K081429 |
05/21/2008 |
THD SLIDE |
THD SPA |
MAUREEN O'CONNELL |
| K081414 |
05/20/2008 |
MODIFICATION TO CORAL SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K081378 |
05/16/2008 |
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS |
Thermo Fisher Scientific |
JACK ROGERS |
| K081345 |
05/14/2008 |
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) |
THERMOGENESIS CORP. |
JOHN CHAPMAN, PHD |
| K081341 |
05/13/2008 |
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K081246 |
05/01/2008 |
TT-102 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
YOUSEF MOHAJER |
| K081242 |
05/01/2008 |
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) |
TOKOTU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K081482 |
05/28/2008 |
CSBP-001A BODY ORGAN PERFUSION SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081279 |
05/06/2008 |
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000 |
TRANSFER TECHNOLOGY |
JOSEPH J ARBOUR |
| K081520 |
05/30/2008 |
SENSITITRE VIZION |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K081510 |
05/29/2008 |
TIGER CANNULATED SCREW SYSTEM |
TRILLIANT SURGICAL LTD |
J. D WEBB |
| K081348 |
05/14/2008 |
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD |
TRIMED, INC. |
KELLI ANDERSON |
| K081449 |
05/23/2008 |
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER |
ULTIMED, INC. |
C. STAMP |
| K081296 |
05/07/2008 |
PREFERENCE PEDICLE SCREW SYSTEM |
US SPINE |
RICHARD JANSEN, PHARM. D. |
| K081479 |
05/27/2008 |
ADVANCE A-CLASS TIBIAL INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
FRED W BOWMAN |
| K081374 |
05/16/2008 |
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K081373 |
05/16/2008 |
EVOLVE EPS SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
