| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080601 |
06/06/2008 |
ERGO++ VERSION 1.7 |
3D LINE MEDICAL SYSTEMS S.R.L. |
THOMAS VALENTINE |
| K080703 |
06/02/2008 |
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK |
4M VENTURES, INC. |
DENICE GALLAGHER |
| K081417 |
06/04/2008 |
FOXCROSS PTA CATHETER |
ABBOTT VASCULAR INC. |
NADINE SMITH |
| K080539 |
06/02/2008 |
ACCIN UNIPOLAR HEAD SYSTEM |
ACCELERATED INNOVATION, LLC |
MICHAEL KVITNITSKY |
| K072861 |
06/24/2008 |
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES) |
ACHEVE TECHNOLOGY, INC. |
JIM-SON CHOU |
| K080100 |
06/30/2008 |
WATCHHALER |
ACTIVAERO AMERICA, INC. |
PAUL DRYDEN |
| K073712 |
06/06/2008 |
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 |
ADROIT MEDICAL SYSTEMS, INC. |
JON R HERMANSON |
| K071916 |
06/02/2008 |
METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K081612 |
06/25/2008 |
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS |
AESCULIGHT, LLC |
PAUL DIAZ |
| K080692 |
06/20/2008 |
MACS CPAP SYSTEM |
AIRON CORPORATION |
ERIC GJERDE |
| K073223 |
06/26/2008 |
S-TEST C02 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K072356 |
06/24/2008 |
S-TEST CA |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K072142 |
06/26/2008 |
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K072140 |
06/24/2008 |
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K072141 |
06/24/2008 |
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID SLAVIN |
| K080073 |
06/30/2008 |
S-TEST CREATININE (CRE) |
ALFA WASSERMANN, INC. |
DAVID SLAVIN |
| K072182 |
06/27/2008 |
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 |
ALMA LASERS LTD. |
ANNE WORDEN |
| K080614 |
06/20/2008 |
DR VISION NEO, DR VISION DOU |
ALMANA MEDICAL IMAGING |
DANIEL KAMM |
| K081304 |
06/11/2008 |
ALZ WEB PACS, VERSION 1.0 |
ALZ, INC. |
CYNTHIA NOLTE |
| K080639 |
06/24/2008 |
SYMPHONY GLUCOSE MANAGEMENT SYSTEM |
ANIMAS CORP. |
AMY SMITH |
| K080536 |
06/19/2008 |
MICRO-TOUCH NITRAFREE |
ANSELL HEALTHCARE PRODUCTS LLC |
LON D MCIIVAIN |
| K081664 |
06/23/2008 |
NOMAD PRO X-RAY SYSTEM |
ARIBEX, INC. |
D. CLARK TURNER |
| K073416 |
06/13/2008 |
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
TOM SPEIKERS |
| K080604 |
06/27/2008 |
PRESSURE INJFECTABLE PICC |
ARROW INTERNATIONAL, INC. |
JULIE LAWSON |
| K080997 |
06/17/2008 |
ASCENSION PYROCARBON LUNATE |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K081160 |
06/24/2008 |
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES |
AVITA CORPORATION |
JENNIFER REICH |
| K080580 |
06/18/2008 |
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D |
AXELGAARD MFG. CO., LTD. |
DAN P JEFFERY |
| K072876 |
06/19/2008 |
PRONTOSAN WOUND IRRIGATION SOLUTION |
B. BRAUN MEDICAL, INC. |
REBECCA STOLARICK |
| K080755 |
06/10/2008 |
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K080812 |
06/25/2008 |
HEMOCCULT ICT |
BECKMAN COULTER, INC. |
SYLVIA ZORICH |
| K081212 |
06/13/2008 |
MRSASELECT - EXTENDED INCUBATION |
BIO-RAD |
FRAN WHITE |
| K081362 |
06/26/2008 |
PLATELIA LYME IGM |
BIO-RAD |
FRAN WHITE |
| K081428 |
06/20/2008 |
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K081589 |
06/13/2008 |
WATERLASE, VERSION 3.0 |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K063261 |
06/23/2008 |
NUCLISENS EASYQ ENTEROVIRUS SYSTEM |
BIOMERIEUX, INC. |
SANDRA PERREAND |
| K080931 |
06/11/2008 |
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080088 |
06/11/2008 |
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS |
BIOMET MANUFACTURING, INC. |
ROBERT R FRIDDLE |
| K080528 |
06/17/2008 |
E-POLY TIBIAL BEARINGS |
BIOMET ORTHOPEDICS, INC. |
MELISSA STEINWEDEL |
| K081395 |
06/25/2008 |
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K081243 |
06/27/2008 |
BIOMET PHOENIX ANKLE NAIL SYSTEM |
BIOMET TRAUMA |
SUSAN ALEXANDER |
| K080330 |
06/11/2008 |
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER |
BIOMET, INC. |
PATRICIA S BERES |
| K080879 |
06/24/2008 |
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K081392 |
06/18/2008 |
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K080269 |
06/06/2008 |
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS |
BIOSITE INCORPORATED |
DAWN A ALLENBY |
| K080876 |
06/04/2008 |
DVX SPINE SYSTEM |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K073316 |
06/20/2008 |
CERAMENT BONE VOID FILLER, MODEL A0210 |
BONESUPPORT AB |
ANN-CHRISTINE PROVOOST |
| K080886 |
06/24/2008 |
IPLAN RT IMAGE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K080888 |
06/11/2008 |
MODEIFICATION TO IPLAN RT DOSE |
BRAINLAB AG |
CARSTEN RAUPACH |
| K080678 |
06/06/2008 |
UNI-KNEE 2.0 |
BRAINLAB AG |
PER PERSSON |
| K073598 |
06/13/2008 |
BARD DIGNICARE STOOL MANAGEMENT SYSTEM |
C.R. BARD, INC. |
MICHELLE GUDITH |
| K081311 |
06/04/2008 |
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER |
C.R. BARD, INC. |
JIHYUN KIM |
| K080023 |
06/16/2008 |
MODIFICATION TO: SPIRIT |
CAIRE, INC. |
ZULFIQAR A CHOUDARY |
| K081324 |
06/17/2008 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS |
CANDELA CORP. |
LISA LACROIX |
| K081648 |
06/24/2008 |
DIGITAL RADIOGRAPHY CXDI-60G |
CANON, INC. |
SHEILA DRISCOLL |
| K080072 |
06/04/2008 |
MRI PATIENT POSITIONING DEVICES |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
ARTHUR WARD |
| K080973 |
06/02/2008 |
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K071984 |
06/27/2008 |
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM |
CMA MICRODIALYSIS AB |
NANCY BLANCO |
| K072326 |
06/24/2008 |
OSTAPEK VBR SYSTEM |
CO-LIGNE AG |
DAVID SCHLERF |
| K081305 |
06/05/2008 |
MERCI RETRIEVER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K081580 |
06/19/2008 |
BEAMER ARGON SNARE PROBE |
CONMED CORPORATION |
KAREN PROVENCHER |
| K081634 |
06/25/2008 |
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL |
CONMED CORPORATION |
SHAWN RIEDEL |
| K072962 |
06/26/2008 |
CABS'AIR |
COUSIN BIOTECH S.A.S. |
STEPHEN PLOQUIN |
| K081564 |
06/30/2008 |
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION |
CREASPINE |
CYNTHIA J NOLTE |
| K081049 |
06/27/2008 |
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
| K080881 |
06/11/2008 |
CURE CATHETER CLOSED SYSTEM |
CURE MEDICAL LLC. |
James Smith |
| K071597 |
06/04/2008 |
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K071603 |
06/25/2008 |
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
| K080175 |
06/09/2008 |
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
KATHLEEN KRAMER |
| K081620 |
06/30/2008 |
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K080828 |
06/27/2008 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
LISA GILMAN |
| K080497 |
06/27/2008 |
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) |
DERMA SCIENCES CANADA, INC. |
SHARMINI ATHERAY |
| K081584 |
06/19/2008 |
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
MARY MCNAMARA-CULLINANE |
| K081164 |
06/13/2008 |
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K072731 |
06/12/2008 |
ENDSNOR |
DOCKSTADER ORTHODONTIC LAB, INC. |
MICHAEL C BAUSMAN |
| K080959 |
06/27/2008 |
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K072985 |
06/20/2008 |
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K081467 |
06/26/2008 |
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION |
EKOS CORP. |
JOCELYN KERSTEN |
| K080585 |
06/11/2008 |
DESKTOP PRO |
ELEKTA LTD. |
PATRICK T.M. HULL |
| K073644 |
06/27/2008 |
ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES |
ENDOGASTRIC SOLUTIONS, INC. |
KEN PERINO |
| K081542 |
06/27/2008 |
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM |
Entellus Medical, Inc. |
Sew-Wah Tay |
| K080146 |
06/06/2008 |
ZIRKONDENT |
ERGOMETA |
MIKE ARTEMOV |
| K073288 |
06/12/2008 |
ETHICON ENDO SURGERY ARTICULATING SNARE |
ETHICON ENDO-SURGERY, INC. |
GLENDA C MARSH |
| K081146 |
06/26/2008 |
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) |
ETHICON ENDO-SURGERY, LLC |
Abhilasha Mukherjee |
| K071755 |
06/03/2008 |
FALCK APPLANATION TONOMETER (FAT2) |
FALCK MEDICAL INC. |
RICHARD E LIPPMAN |
| K080904 |
06/04/2008 |
FEEL-FINE INSULIN PEN NEEDLE |
FEEL TECH |
DANIEL KAMM |
| K080765 |
06/20/2008 |
CROSSER LP SYSTEM |
FLOWCARDIA, INC. |
Dustin Michaels |
| K080684 |
06/09/2008 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
Diana Hong |
| K073330 |
06/20/2008 |
FREEDOM SCIENCES MOTION CONTROL MODULE (MCM) |
FREEDOM SCIENCES, LLC |
EDWARD A KROLL |
| K081308 |
06/04/2008 |
FUJIFILM FCR VIEW, MODEL CR-VW674 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBRA A PEACOCK |
| K072939 |
06/09/2008 |
HE4 EIA, MODEL: 404-10 US |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L DICKSON |
| K081041 |
06/27/2008 |
GPS, G SURGICAL PEDICLE SYSTEM |
G SURGICAL CO., LTD. |
DONALD GRAFTON |
| K080519 |
06/13/2008 |
PRISMAFLEX M150 SET |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K080724 |
06/11/2008 |
GC OPB-100 |
GC AMERICA, INC. |
MARK HEISS |
| K080478 |
06/05/2008 |
GRADIA FORTE |
GC AMERICA, INC. |
MARK HEISS |
| K081091 |
06/11/2008 |
PRECISION 500D R&F X-RAY SYSTEM |
GE HEALTHCARE |
MICHAEL PETROWSKI |
| K080251 |
06/20/2008 |
APEXPRO TELEMETRY SYSTEMS |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
BERNARD SANDLER |
| K081496 |
06/12/2008 |
OPTIMA PET/CT 560 |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K081578 |
06/20/2008 |
ACCELA SYSTEM |
GENESIS BIOSYSTEMS, INC. |
STEPHEN J MACDONALD |
| K080181 |
06/24/2008 |
MODIFICATION TO GALILEO GOLD |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K073225 |
06/30/2008 |
SENSEI CATHETER CONTROL SYSTEM |
HANSEN MEDICAL, INC. |
DOUG WORTH |
| K081327 |
06/19/2008 |
RELIMESH |
HERNIAMESH S.R.L. |
LORENA TRABUCCO |
| K081198 |
06/18/2008 |
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K081044 |
06/03/2008 |
REJUVENATE MODULAR HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
DENISE DAUGERT |
| K081152 |
06/10/2008 |
T2 FEMORAL NAIL |
HOWMEDICA OSTEONICS CORP. |
DANIELLE HILLMAN |
| K080706 |
06/09/2008 |
CONNEXX LOCKING TIBIA NAIL |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K080223 |
06/24/2008 |
ZURA TEE SYSTEM |
IMACOR LLC |
STEVEN B DATLOF M.D., J.D. |
| K081057 |
06/17/2008 |
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL |
INTACT MEDICAL CORPORATION |
DOUGLAS MACARTHUR |
| K081477 |
06/18/2008 |
LUXTEC MLX LIGHT SOURCE |
INTEGRA LUXTEC, INC. |
RITA WADLEIGH |
| K080798 |
06/27/2008 |
INTEL HEALTH GUIDE, MODEL: PHS6000 |
INTEL CORP. |
TAE-WOONG KOO |
| K081399 |
06/06/2008 |
AVIATOR TRANSPORT INCUBATOR |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K081262 |
06/17/2008 |
DC NEURO |
INVIVO CORPORATION |
THEODORE J REISKER |
| K081471 |
06/24/2008 |
ECARD AND CCARD |
IRHYTHM TECHNOLOGIES, INC. |
WILLIAM H RIGHTER |
| K081037 |
06/09/2008 |
WATCH-PAT 200I (WP200I) |
ITAMAR MEDICAL |
JOHATHAN S KAHAN |
| K080555 |
06/03/2008 |
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) |
IVU IMAGING CORPORATION |
MARK L STRIBLING |
| K081381 |
06/13/2008 |
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K080677 |
06/06/2008 |
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE |
KALTENBACH & VOIGT GMBH & CO. |
CLAUDIA ORTIZ |
| K081027 |
06/30/2008 |
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) |
KIMBERLY-CLARK CORP. |
RICHARD W WOLFE |
| K080537 |
06/30/2008 |
L-VARLOCK |
KISCOMEDICA S.A. |
J.D. WEBB |
| K080523 |
06/17/2008 |
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K081133 |
06/10/2008 |
KYMCO FORU, MODEL EQ40 |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K073702 |
06/26/2008 |
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR |
LAZARUS MEDICAL LLC |
CYNTHIA J.M NOLTE |
| K081221 |
06/19/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K081318 |
06/09/2008 |
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM |
LIFESCAN, INC. |
FRANK PERALTA |
| K080902 |
06/13/2008 |
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 |
LORENZ BIOTECH S.P.A. |
ROSINA ROBINSON |
| K081483 |
06/25/2008 |
XTAG RESPIRATORY VIRAL PANEL |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K080932 |
06/09/2008 |
MOSAIC LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K080609 |
06/13/2008 |
SWC/DWC WARMING CABINETS |
MAC MEDICAL |
DANIEL KAMM |
| K080368 |
06/20/2008 |
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K073179 |
06/09/2008 |
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 |
MAQUET CRITICAL CARE AB |
JAMIE YIEH |
| K080506 |
06/09/2008 |
MARTIN CHAIR, MODEL C4S1 |
MARTIN MANUFACTURING CO., LLC |
MICHAEL ZAPATA, III |
| K080112 |
06/20/2008 |
PATIENT CABLE |
MED-DYNE |
E.W. JOHNSON |
| K080657 |
06/30/2008 |
NEB-90 LARGE VOLUME MEDICATION NEBULIZER |
MEDI NUCLEAR CORP., INC. |
MICHAEL MCPECK |
| K081473 |
06/27/2008 |
HERO, VERSION 2.0 |
MEDICAL PREDICTIVE SCIENCE CORP. |
WILLIAM E KING |
| K072602 |
06/18/2008 |
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM |
MEDPRO SAFETY PRODUCTS, INC. |
GREG E MITCHELL |
| K080297 |
06/17/2008 |
MEDRAD INTEGO PET INFUSION SYSTEM |
MEDRAD, INC. |
TROY A JACK |
| K081297 |
06/11/2008 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K062254 |
06/16/2008 |
AXIS FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD CHIN |
| K081573 |
06/27/2008 |
MEDTRONIC EXPORT AP CATHETER |
MEDTRONIC VASCULAR |
TARA N TURNEY |
| K073556 |
06/24/2008 |
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS |
MEDXPERT GMBH |
FRANZ MENEAN |
| K081484 |
06/20/2008 |
HORIZON XVU |
MENNEN MEDICAL LTD. |
IFAT OREN |
| K080772 |
06/03/2008 |
BONEMEDIK-DM |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K080379 |
06/30/2008 |
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K080550 |
06/10/2008 |
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 |
MINOS MEDICAL |
TOM COLONNA |
| K080589 |
06/11/2008 |
SATURN 9000-810 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
| K081628 |
06/20/2008 |
MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K081665 |
06/27/2008 |
MILLENIUM II |
NEXT MOBILITY, LLC |
JOSEPH AZARY |
| K070844 |
06/06/2008 |
NILIMEDIX ADI |
NILIMEDIX LTD. |
YORAM LEVY |
| K081285 |
06/05/2008 |
FINGER PULSE OXIMETER, MODEL 9560 |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K081094 |
06/20/2008 |
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 |
OLYMPIC MEDICAL CORP. |
STEVE HESLER |
| K080180 |
06/11/2008 |
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) |
OPTICAL IMAGING LTD. |
JONATHAN S KAHAN |
| K073631 |
06/27/2008 |
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 |
ORQIS MEDICAL CORPORATION |
RYAN KELLY |
| K081411 |
06/30/2008 |
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K081097 |
06/03/2008 |
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM |
ORTHOPEDIATRICS, LLC |
GARY BARNETT |
| K081439 |
06/17/2008 |
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
DAVID J MCILHENNY |
| K081052 |
06/18/2008 |
OCCLUSION BALLOON CATHETER, MODEL VENOS |
Oscor Inc. |
MILA DOSKOCIL |
| K080675 |
06/20/2008 |
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K080244 |
06/20/2008 |
PALOMAR LUX 1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K072427 |
06/11/2008 |
SIGMA SERIES HYPERBARIC CHAMBER |
PERRY BAROMEDICAL CORP. |
JOHN CROCKER |
| K081426 |
06/04/2008 |
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MELINDA NOVATNY |
| K081661 |
06/24/2008 |
HD15 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
|
| K073229 |
06/06/2008 |
NERVE MONITORING CABLE |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080197 |
06/24/2008 |
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM |
PLASMA SURGICAL, LTD. |
PETER GIBSON |
| K081454 |
06/13/2008 |
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K073708 |
06/03/2008 |
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
PRECISION SURGERY LTD. |
KAREN E WARDEN |
| K081555 |
06/27/2008 |
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED |
PROCTER & GAMBLE CO. |
LENORE FAULHABER |
| K080381 |
06/25/2008 |
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA |
QUEST DIAGNOSTICS, INC. |
LIUMING YU |
| K080516 |
06/23/2008 |
LAMIN AIR |
REMGENIC LLC |
PAUL DRYDEN |
| K080652 |
06/20/2008 |
MERCURY VCO2 MODULE WITH CAPNOSTAT 5 |
RESPIRONICS NOVAMETRIX LLC |
KEVIN MADER |
| K080617 |
06/27/2008 |
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
NIELS SCHMIDT |
| K081032 |
06/06/2008 |
TR-USB TELEPHONIC STETHOSCOPE |
RNK PRODUCTS, INC. |
CHARLES R ABBRUSCATO |
| K073501 |
06/09/2008 |
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG |
ROCHE DIAGNOSTICS CORP. |
THERESA A BUSH |
| K080811 |
06/20/2008 |
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K081538 |
06/19/2008 |
TUTOPATCH, TUTOMESH |
RTI BIOLOGICS, INC. |
TRAVIS AROLA |
| K080687 |
06/20/2008 |
SMARTBURS |
S.S. WHITE BURS, INC. |
DEREK GLADDEN |
| K081219 |
06/30/2008 |
APOLLO MINI IPL SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K081469 |
06/12/2008 |
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 |
SECTRA IMTEC AB |
CARL ALLETO |
| K073634 |
06/19/2008 |
MULTIGENT CREATININE (ENZYMATIC) ASSAY |
SENTINEL CH. SpA |
FABIO ROTA |
| K081533 |
06/25/2008 |
SENTINEL PLASMAPROTEINS CAL 3X |
SENTINEL CH. SpA |
FABIO ROTA |
| K081322 |
06/18/2008 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
CHARLES MACK |
| K081340 |
06/18/2008 |
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
CHARLES MACK |
| K073577 |
06/23/2008 |
SHARPS TRANSPORT TUBE, MODEL 50035 |
SHARPS COMPLIANCE, INC. |
DAVID OLMSTEAD |
| K073280 |
06/23/2008 |
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K080517 |
06/11/2008 |
RESICEM |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K080834 |
06/11/2008 |
VINTAGE ART |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K073537 |
06/27/2008 |
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
NOOR MALKI |
| K081453 |
06/23/2008 |
BIOGRAPH HD FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K081022 |
06/02/2008 |
SOMATOM DEFINITION, MODEL AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORRINE MCLEOD |
| K081121 |
06/04/2008 |
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MARTINA VOGT |
| K081332 |
06/10/2008 |
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K072198 |
06/06/2008 |
X-VOID, SPIDER |
SINTEA BIOTECH, INC. |
GUSTAVO A RIOS |
| K081106 |
06/18/2008 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 |
SMITH & NEPHEW, INC. |
LAURA SEJNOWSKI |
| K072852 |
06/09/2008 |
SL-PLUS STANDARD AND LATERAL HIP STEMS |
SMITH & NEPHEW, INC. |
NICHOLAS B TABRIZI |
| K081491 |
06/19/2008 |
SMITH & NEPHEW CDS SYSTEM |
SMITH & NEPHEW, INC. |
MASON W ROBBINS |
| K072080 |
06/02/2008 |
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
| K072169 |
06/19/2008 |
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K081458 |
06/06/2008 |
PROVEN STEM EXTENDER |
STELKAST COMPANY |
DONALD A STEVENS |
| K081427 |
06/11/2008 |
BROWNE OPA TEST STRIP |
STERIS Corporation |
ROBERT SULLIVAN |
| K080773 |
06/09/2008 |
THOR ANTERIOR PLATING SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K081379 |
06/11/2008 |
MODIFICATION TO INREACH SYSTEM |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
| K073109 |
06/04/2008 |
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K080447 |
06/13/2008 |
SURGICRAFT SCREW FIXATION SYSTEM |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K081002 |
06/09/2008 |
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE |
SUTURES INDIA PVT., LTD. |
L.G. CHANDRASEKHAR |
| K081001 |
06/09/2008 |
PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE |
SUTURES INDIA PVT., LTD. |
L.G. CHANDRASEKHAR |
| K081003 |
06/09/2008 |
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE |
SUTURES INDIA PVT., LTD. |
L.G. CHANDRASEKHAR |
| K081144 |
06/23/2008 |
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080014 |
06/09/2008 |
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080283 |
06/27/2008 |
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K072560 |
06/17/2008 |
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) |
TEIKOKU PHARMA USA, INC. |
MARGIE NEMCIK-CRUZ |
| K080230 |
06/09/2008 |
NEB-U-MASK SYSTEM, MODELS 1895, 1896 |
Teleflex Medical, Inc. |
PAUL DRYDEN |
| K080034 |
06/17/2008 |
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
ANDREA WALLEN |
| K080384 |
06/06/2008 |
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K081414 |
06/17/2008 |
MODIFICATION TO CORAL SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K080962 |
06/25/2008 |
LITE WAND II |
THOMPSON SURGICAL INSTRUMENTS, INC. |
STEPHANIE A ZALUCHA |
| K080615 |
06/17/2008 |
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
KEVIN GEMAS |
| K081242 |
06/11/2008 |
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) |
TOKOTU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K080940 |
06/19/2008 |
ESTELITE SIGMA QUICK |
TOKUYAMA DENTAL CORPORATION |
KEITH BARRITT |
| K081065 |
06/06/2008 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081482 |
06/11/2008 |
CSBP-001A BODY ORGAN PERFUSION SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081621 |
06/23/2008 |
INFX-8000C (INFINIX CC-I AND VC-I) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081624 |
06/23/2008 |
INFX-8000F (INFINIX CSI AND INFINIX DPI) |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081582 |
06/17/2008 |
INFX-8000V, INFINIX-CFI AND INFINIX VFI |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K081055 |
06/04/2008 |
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) |
TOTOKU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K081056 |
06/04/2008 |
21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) |
TOTOKU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K081183 |
06/19/2008 |
WOUNDSTAT |
TRAUMACURE INC. |
CAMPBELL HUTTON |
| K072854 |
06/30/2008 |
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K081449 |
06/03/2008 |
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER |
ULTIMED, INC. |
C. STAMP |
| K080600 |
06/25/2008 |
ULTIMED ULTICARE SAFETY SYRINGE |
ULTIMED, INC. |
CAROLE STAMP |
| K081296 |
06/06/2008 |
PREFERENCE PEDICLE SCREW SYSTEM |
US SPINE |
RICHARD JANSEN, PHARM. D. |
| K080970 |
06/11/2008 |
USHIFU STEPPER |
USHIFU DEVELOPMENT COMPANY, LLC |
MARE RYAN |
| K081076 |
06/20/2008 |
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE |
VELOCITY MEDICAL SOLUTIONS, LLC |
PAUL SUMNER |
| K080673 |
06/10/2008 |
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE |
VERTEBRAL TECHNOLOGIES, INC. |
PHILIP B JARVI |
| K071973 |
06/20/2008 |
EPLEY OMNIAX |
VESTICON |
CATHRYN EPLEY |
| K080734 |
06/26/2008 |
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K080679 |
06/27/2008 |
MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K080859 |
06/04/2008 |
DRF 4343 |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO C SANTIN |
| K081585 |
06/20/2008 |
ENDOSCOPY VIDEO CAMERA SYSTEM |
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS |
CHRISTINE E NICHOLS |
| K080816 |
06/24/2008 |
VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT |
VISUAL FOOTCARE TECHNOLOGIES, LLC |
ANDREW SINGER |
| K073155 |
06/04/2008 |
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K080304 |
06/20/2008 |
PRO TENS, MODEL WL-240 RX |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K080955 |
06/27/2008 |
ZEN PROGRAM (MIND 440 HEARING AID) |
WIDEX HEARING AID CO., INC. |
FRANCIS KUK |
| K081590 |
06/19/2008 |
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J |
YA HORNG ELECTRONIC CO., LTD. |
STEVEN CHANG |
| K080366 |
06/09/2008 |
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES |
ZEFON INTL. |
SCOTT RYAN |
