| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K091910 |
10/01/2009 |
PICCOLO MAGNESIUM TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K092986 |
10/27/2009 |
ACACIA PISTON SYRINGE |
ACACIA, INC. |
FERGIE FERGUSON |
| K092926 |
10/28/2009 |
ACELL MATRISTEM WOUND SHEET |
ACELL, INC |
RODNEY W BOSLEY |
| K091354 |
10/21/2009 |
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING |
ACRYMED, INC. |
CHARLES K GRIFFIN |
| K083626 |
10/19/2009 |
DISTRACTABLE WAVE CAGE |
ADVANCED MEDICAL TECHNOLOGY, INC. |
J.D. WEBB |
| K092990 |
10/23/2009 |
AMD 6605 TENS/NMES |
ADVANTAGEOUS MEDICAL DEVICES, LLC |
JOHN HEROD |
| K091284 |
10/28/2009 |
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K091369 |
10/14/2009 |
ELECTROFLUIDGRAPH |
AKERN USA, LLC |
KEVIN WELLS |
| K091777 |
10/20/2009 |
ALCON ULTRACHOPPER |
ALCON RESEARCH, LTD. |
MARTIN A KAUFMAN |
| K091413 |
10/26/2009 |
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
| K091240 |
10/23/2009 |
ALPHAMED SURGICAL SPEAR, MODEL 70-5000 |
ALPHAMED INC. |
JAMES GUBACHY |
| K092824 |
10/21/2009 |
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 |
ALPHAPROTECH, INC. |
DAVID KITCHEN |
| K092225 |
10/09/2009 |
AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR |
AMYLIOR, INC. |
ERIC DUGAS |
| K083133 |
10/30/2009 |
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS |
ANDOVER HEALTHCARE INC. |
VALERIE GUNN |
| K092539 |
10/01/2009 |
SEAMFREE |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
| K090751 |
10/23/2009 |
COMET ANTERIOR CERVICAL PLATE SYSTEM |
APOLLO SPINE, INC. |
ANN-MARIE FRANCIS |
| K090472 |
10/14/2009 |
GRIND GUARD |
ARCHTEK, INC. |
KRISTA OAKES |
| K092182 |
10/09/2009 |
VOYAGER COMPACT IMAGING SYSTEM |
Ardent Sound, Inc. |
DEBORAH VAN GORDER |
| K091102 |
10/23/2009 |
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS |
ARKRAY Factory USA, Inc. |
HAMID IDRISSI |
| K090653 |
10/09/2009 |
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
HAMID IDRISSI |
| K091196 |
10/27/2009 |
GRS GLENOID RESURFACING SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K092425 |
10/21/2009 |
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
| K093183 |
10/23/2009 |
BIS QUATRO SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K092112 |
10/06/2009 |
BTI DENTAL IMPLANT TINY 2.5-3.0 |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
ALFREDO GOMEZ |
| K092729 |
10/02/2009 |
BAXANO NEURO CHECK DEVICE |
BAXANO, INC. |
CINDY DOMECUS |
| K092318 |
10/30/2009 |
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE |
BAXTER HEALTHCARE CORPORATION |
VALERIE FOLLOWELL |
| K092337 |
10/16/2009 |
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K091846 |
10/16/2009 |
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K091758 |
10/09/2009 |
BD SPINAL NEEDLE 27G |
BECTON DICKSON & CO. |
PASQUALE AMATO |
| K090716 |
10/06/2009 |
BEGO SEMADOS S-LINE |
BEGO IMPLANT SYSTEMS GMBH & CO. KG |
MARTIN ELLERHORST |
| K092296 |
10/21/2009 |
POWDER FREE EXAMINATION GLOVE |
BETTERCARE PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K092301 |
10/22/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) |
BETTERCARE PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K092294 |
10/21/2009 |
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR |
BETTERCARE PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K092035 |
10/15/2009 |
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION |
BICON, LLC |
VINCENT J MORGAN |
| K092355 |
10/29/2009 |
MONOLISA ANTI-HAV EIA |
BIO-RAD LABORATORIES, INC. |
LINDA STASWICK |
| K092353 |
10/29/2009 |
MONOLISA ANTI-HAV IGM EIA |
BIO-RAD LABORATORIES, INC. |
LINDA STASWICK |
| K091414 |
10/21/2009 |
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH |
BIOCARE CORP. |
JUDY WEI |
| K083927 |
10/01/2009 |
WATERLASE MD |
BIOLASE TECHNOLOGY, INC. |
IOANNA RIZOU |
| K092150 |
10/27/2009 |
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT |
BIOMET, INC. |
SUSAN ALEXANDER |
| K090017 |
10/13/2009 |
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K091789 |
10/01/2009 |
CARTO RMT EP NAVIGATION SYSTEM V8 |
BIOSENSE WEBSTER, INC. |
DIANA THORSON |
| K092197 |
10/06/2009 |
PHOTEX30 DIODE LASER SERIES: 980, 810, 940 |
BIOTEX, INC. |
ASHOK GOWDA |
| K091440 |
10/09/2009 |
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L |
BOVIE MEDICAL |
RICHARD KOZLOFF |
| K092212 |
10/09/2009 |
BUSSE SURGICAL DRAPES III |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K091913 |
10/30/2009 |
HI TECH IMPLANT, HT PHYSIO IMPLANT |
BY DENTAL SRL |
DANIELE POLI |
| K082207 |
10/23/2009 |
ORTHOCAD IQ |
CADENT, INC. |
LAURIE CLARKE |
| K092949 |
10/08/2009 |
IMAGEGRID RADIOLOGY VIEWER SYSTEM |
CANDELIS, INC. |
CARL ALETTO |
| K092616 |
10/21/2009 |
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K093300 |
10/30/2009 |
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K091471 |
10/15/2009 |
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL |
CARTAGLOVES S.A. |
SAM KAO |
| K090487 |
10/19/2009 |
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 |
COEUR, INC. |
DEBRA MANNING |
| K091703 |
10/14/2009 |
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K092898 |
10/19/2009 |
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES |
CONMED LINVATEC |
LORNA K LINVILLE |
| K091767 |
10/09/2009 |
3 WAY SILICONE FOLEY BALLOON CATHETER |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
| K092205 |
10/30/2009 |
PALINDROME P HEMODIALYSIS CATHETER |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
Daniel Campion |
| K092195 |
10/01/2009 |
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) |
CUTERA, INC. |
KATHY MAYNOR |
| K091736 |
10/30/2009 |
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 |
DANIELS CORPORATION PTY, INC. |
ANDREA ARREDONDO |
| K092547 |
10/30/2009 |
DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX |
DENTIMAX |
KORINA A AKHONDZADEH |
| K093221 |
10/30/2009 |
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K092882 |
10/21/2009 |
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K092873 |
10/27/2009 |
REVERSE SHOULDER PROSTHESIS |
DJO SURGICAL |
TEFFANY HUTTO |
| K090055 |
10/27/2009 |
LOW & HIGH SPEED KIT |
DPM USA CORP. |
GEORGE ECHEVERRI |
| K090991 |
10/09/2009 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO |
E-WOO TECHNOLOGY |
VINCENT LEE |
| K091305 |
10/23/2009 |
CLEARPATH |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K092336 |
10/15/2009 |
C-THRU SPINAL SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K092010 |
10/22/2009 |
PC ECG, MODEL SE-1010 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K092509 |
10/08/2009 |
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE |
EDWARDS LIFESCIENCES, LLC. |
KAREN JONES |
| K091709 |
10/13/2009 |
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K091871 |
10/23/2009 |
DK50 DS |
EKOM S.R.O. |
PAUL DRYDEN |
| K091000 |
10/26/2009 |
KNEEKG |
EMOVI |
EMMANUEL MONTINI |
| K092289 |
10/20/2009 |
EMS AIR-FLOW HANDY PERIO |
EMS ELECTRO MEDICAL SYSTEMS SA |
CYNTHIA J NOLTE |
| K091542 |
10/20/2009 |
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K092783 |
10/22/2009 |
DEBP |
ENKO LTD. |
SINAN KAZAZOGLU |
| K092111 |
10/02/2009 |
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 |
ENTOMED AB |
CHARLOTTE MATTISSON |
| K092418 |
10/23/2009 |
ENTRACARE GASTROSTOMY FEEDING TUBE |
ENTRACARE, LLC |
BRANDON CONVERSE |
| K092913 |
10/16/2009 |
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 |
EP MEDSYSTEMS |
SUSHMA RAO |
| K092887 |
10/21/2009 |
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K091290 |
10/29/2009 |
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 |
ETHICON ENDO-SURGERY, INC. |
TOM BOSTICCO |
| K091458 |
10/15/2009 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 |
EV3 NEUROVASCULAR |
TOM DAUGHTERS |
| K092770 |
10/09/2009 |
SIMPLYGO HANDS FREE BREAST PUMP |
EVENFLO COMPANY, INC. |
AMY NEFF |
| K092297 |
10/09/2009 |
ELETONE CREAM |
FERNDALE PHARMA GROUP, INC. |
RICHARD A HAMER |
| K092218 |
10/06/2009 |
FLEXICARE BREATHING FILTERS |
FLEXICARE MEDICAL LTD. |
DAVID MOYNHAM |
| K093234 |
10/30/2009 |
INTEGRATED REGISTRATION |
GE MEDICAL SYSTEMS SCS |
SOPHIE LE LOARER |
| K091833 |
10/16/2009 |
GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. |
GEMORE TECHNOLOGY CO., LTD. |
BODEN LAI |
| K092471 |
10/02/2009 |
MODEL SENTINELLA 102 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A |
SEVERINE MOINE |
| K092623 |
10/30/2009 |
F.A.S.T. SYSTEM SED AND CXD |
GENESIS MEDICAL INTERVENTIONAL, INC. |
ANNE WORDEN |
| K091918 |
10/07/2009 |
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO |
GENORAY CO., LTD. |
SHIN KUK YOO |
| K092513 |
10/09/2009 |
RAINBOW BLOCK |
GENOSS CO., LTD. |
EUNKYUNG SON |
| K091878 |
10/06/2009 |
OSSEOLINK DENTAL IMPLANT SYSTEM |
GLOBAL IMPLANT SOLUTIONS, LLC |
STUART R GOLDMAN |
| K093023 |
10/29/2009 |
PTFE PEELABLE INTRODUCER |
Greatbatch Medical |
Kristi Fox |
| K082891 |
10/20/2009 |
LENSTAR, MODEL LS900 |
HAAG-STREIT AG |
LENA SATTLER |
| K092650 |
10/09/2009 |
HEARTWAY POWER MOBILITY SCOOTER, S12 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KE MIN JEN |
| K092037 |
10/02/2009 |
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
Cindy Green |
| K092245 |
10/28/2009 |
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 |
HONSUN (NANTONG) CO., LTD |
David Zhang |
| K083552 |
10/09/2009 |
MAXMORESPINE TOM STICK |
HOOGLAND SPINE PRODUCTS GMBH |
BORIS MIKLITZ |
| K092570 |
10/16/2009 |
ABX PENTRA TPU CAL, MODEL A11A01898 |
HORIBA ABX SAS |
CAROLINE FERRER |
| K092561 |
10/20/2009 |
REJUVENATE MODULAR STEM |
HOWMEDICA OSTEONICS CORP |
ESTELA CELI |
| K090897 |
10/23/2009 |
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K092834 |
10/08/2009 |
HOFFMAN XPRESS LINE EXTENSION |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K092381 |
10/27/2009 |
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION |
IBALANCE MEDICAL, INC. |
JANICE M HOGAN |
| K090712 |
10/02/2009 |
EOCENE SYSTEM |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K092544 |
10/26/2009 |
INSTRUMED VASCULAR CLAMPS |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K090563 |
10/09/2009 |
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K091100 |
10/23/2009 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL, INC. |
JONATHAN S KAHAN |
| K092177 |
10/15/2009 |
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 |
INVATEC S.P.A. |
STEVE CAMP |
| K092361 |
10/29/2009 |
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER |
INVATEC S.P.A. |
JOHN CLAY |
| K091787 |
10/09/2009 |
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR |
IVY BIOMEDICAL SYSTEMS, INC. |
JENNIFER LAINE |
| K091065 |
10/16/2009 |
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 |
J. MORITA USA, INC. |
KEITH BARRITT |
| K092432 |
10/09/2009 |
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) |
JAWON MEDICAL CO., LTD. |
H L JUNG |
| K092431 |
10/08/2009 |
BODY COMPOSITION ANALYZER, MODEL: IOI 353 |
JAWON MEDICAL CO., LTD. |
Won-Hee Park |
| K091679 |
10/02/2009 |
LEFORTE SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
SHIN KUK YOO |
| K092806 |
10/09/2009 |
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K090919 |
10/02/2009 |
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE |
KENSEY NASH CORP. |
Alyssa Schwartz |
| K091499 |
10/22/2009 |
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) |
KENSEY NASH CORP. |
Alyssa Schwartz |
| K091613 |
10/07/2009 |
TAKE 1 |
KERR CORP. |
COLLEEN BOSWELL |
| K092867 |
10/01/2009 |
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT |
KETTENBACH GMBH & CO KG |
MICHAELA ZINKE |
| K092717 |
10/30/2009 |
DIRECT DIGITIZER, REGIUS MODEL 210 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSEL MUNVES |
| K092281 |
10/27/2009 |
CLEARFIL MAJESTY POSTERIOR PLT |
KURARAY MEDICAL INC. |
KIYOYUKI ARIKAWA |
| K092536 |
10/30/2009 |
SPINAL FIXATION SYSTEM |
LANX, INC. |
JANICE M HOGAN |
| K091915 |
10/27/2009 |
FLUID ISOLATION DEVICE |
LENSTEC, INC. |
JIMMY CHACKO |
| K090051 |
10/08/2009 |
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K090006 |
10/15/2009 |
LIFEBRIDGE B2T, MODEL 7001 |
LIFEBRIDGE MEDIZINTECHNIK AG |
KATHLEEN JOHNSON |
| K091115 |
10/30/2009 |
ECO2 LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K090689 |
10/29/2009 |
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 |
MAQUET CARDIOPULMONARY AG |
INGRID RICHTER |
| K092838 |
10/15/2009 |
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K091696 |
10/26/2009 |
SAVI WIRELESS, MODEL PM500 |
MEDICOMP, INC. |
SUSAN GOLDSTEIN-FALK |
| K091780 |
10/16/2009 |
GUIDED MEASUREMENT CATHETER (GMC) |
MEDIGUIDE, LTD. |
JONATHAN S KAHAN |
| K091781 |
10/16/2009 |
GUIDED MEDICAL POSITIONING SYSTEM (GMPS) |
MEDIGUIDE, LTD. |
JONATHAN S KAHAN |
| K090568 |
10/02/2009 |
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K092676 |
10/02/2009 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
LILA JOE |
| K093058 |
10/26/2009 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
JENNIFER MCBRIDE |
| K092303 |
10/27/2009 |
MERIT LAUREATE HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN CHRISTENSEN |
| K091584 |
10/09/2009 |
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN CHRISTENSEN |
| K091540 |
10/08/2009 |
MTD 4000 |
METTLER ELECTRONICS CORP. |
ROBERT FLEMING |
| K092456 |
10/23/2009 |
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K093002 |
10/28/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 |
MICROVENTION, INC. |
Naomi Gong |
| K092581 |
10/30/2009 |
MITS DICOM GATEWAY AND IMAGE MANAGER |
MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. |
Ke-Min Jen |
| K091217 |
10/02/2009 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ JOY |
| K092566 |
10/09/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) |
NANOSPHERE, INC |
GREGORY W SHIPP |
| K092957 |
10/21/2009 |
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST |
NANOSPHERE, INC |
GREGORY SHIPP |
| K092292 |
10/28/2009 |
CHECKPOINT |
NDI MEDICAL LLC |
JULIE GRILL |
| K092085 |
10/07/2009 |
ISPIRA RESUSCITATION UNIT |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
| K090866 |
10/21/2009 |
NEUROCALM MODEL 1 AND 2 |
NEUROMED DEVICES, INC |
ROBERT SEIPLE |
| K091721 |
10/02/2009 |
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 |
NEW MEDICAL TECHNOLOGIES GMBH |
VINCE D'ALESSANDRO |
| K091803 |
10/09/2009 |
SMARTTRACK SYSTEM |
NEXUS6, LTD. |
GARTH SUTHERLAND |
| K091848 |
10/16/2009 |
NOBEL/PROCERA IMPLANT BRIDGE |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K091907 |
10/06/2009 |
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K092678 |
10/01/2009 |
EVISION DATA MANAGEMENT SOFTWARE |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K092101 |
10/21/2009 |
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES |
NONIN MEDICAL, INC. |
LORI ROTH |
| K092253 |
10/08/2009 |
MODIFICATION TO FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
CHANDANA GURUNG BHANDARI |
| K092011 |
10/28/2009 |
NORM SPINAL SYSTEM |
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR |
NURAY DOGAN |
| K090190 |
10/09/2009 |
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM |
NUCLEMED S.A. |
RAYMOND KELLY |
| K092804 |
10/08/2009 |
MICROSELECTRON HDR V2, MODEL 105.999 |
NUCLETRON CORP. |
ELAINA COLBY |
| K091386 |
10/02/2009 |
MICROFUSE DUAL RATE INFUSER |
NUMIA MEDICAL TECHNOLOGY, LLC |
ERIC FLACHBART |
| K091623 |
10/09/2009 |
LAMINOPLASTY FIXATION SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K092287 |
10/06/2009 |
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K091064 |
10/27/2009 |
NAVILAS LASER SYSTEM |
OD -OS GMBH |
Judy Gordon |
| K092309 |
10/30/2009 |
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K092443 |
10/23/2009 |
INTERFACE ACETABULAR CUP LINERS |
OMNI LIFE SCIENCE, INC. |
WILLIAM MCCALLUM |
| K093251 |
10/29/2009 |
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K092939 |
10/09/2009 |
PATLOG 2.0 |
ONCOLOG MEDICAL QA AB |
JAN TORNQVIST |
| K092014 |
10/08/2009 |
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
ONSET MEDICAL CORPORATION |
|
| K092039 |
10/16/2009 |
IDENTEVENT, VERSION 1.0G |
OPTIMA NEUROSCIENCE, INC. |
PAULA WILKERSON |
| K092056 |
10/01/2009 |
OPTOMED SMARTSCOPE, MODEL M3-1 EY1 |
OPTOMED OY |
LAURA OJALA |
| K090705 |
10/09/2009 |
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT |
ORTHO DEVELOPMENT CORP. |
JOHANNE YOUNG |
| K090474 |
10/19/2009 |
ORTHOREX INTRA-OPERATIVE LOAD SENSOR |
ORTHOSENSOR, INC. |
JON WARD |
| K083077 |
10/26/2009 |
ULC SPINAL PEDICLE SCREW SYSTEM |
OTIS BIOTECH CO., LTD |
JISUK YOO |
| K091446 |
10/27/2009 |
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE, RAC, CCRA |
| K091512 |
10/30/2009 |
BUILD-IT LIGHT CURE |
PENTRON CLINICAL TECHNOLOGIES |
Wendy Garman |
| K090008 |
10/15/2009 |
TANDA RESTORE, MODEL PTSCS |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K092747 |
10/09/2009 |
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL A CHILBERT |
| K091389 |
10/22/2009 |
EQUALSHIELD LUER LOCK CONNECTOR PAIR |
PLASTMED, LTD. |
ELISSA BURG |
| K090703 |
10/20/2009 |
POLY-CHEM 90 GLUCOSE |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K092961 |
10/23/2009 |
JAZZY FRONTIE |
PRIDE MOBILITY PRODUCTS CORP. |
KIMBERLY BLAKE |
| K090641 |
10/23/2009 |
CURIOS |
PROGENTIX ORTHOBIOLOGY B.V. |
YVONNE P BOVELL |
| K092034 |
10/19/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK |
PT. SMART GLOVE INDONESIA |
SOON TUCK KWAN |
| K090639 |
10/29/2009 |
EXELO2, MODEL 4010 |
QUANTEL DERMA GMBH |
MICHAEL JOHNSON |
| K091433 |
10/28/2009 |
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL |
R & D SYSTEMS, INC. |
NANCY RING |
| K092105 |
10/09/2009 |
RADIANALYZER XPRESS |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K092408 |
10/14/2009 |
RHYTHM OF LIFE, MODEL R0901-05 |
RAPID RESPONSE SOLUTIONS, LLC |
JORGE MILAN |
| K082756 |
10/21/2009 |
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K092026 |
10/02/2009 |
EASYCARE TX, TX LINK |
RESMED LTD. |
DAVID D'CRUZ |
| K090539 |
10/30/2009 |
BIPAP AUTOSV ADVANCED |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K091191 |
10/23/2009 |
GAS TRANSFILL |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K093116 |
10/21/2009 |
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY |
RESPONSE BIOMEDICAL CORP. |
KEN PILGRIM |
| K083260 |
10/16/2009 |
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN |
Roche Diagnostics |
JACK ROGERS |
| K092585 |
10/30/2009 |
ELECSYS RUBELLA IGGA CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K092070 |
10/06/2009 |
INTERPLATE C |
RSB SPINE LLC. |
KAREN E WARDEN |
| K090361 |
10/08/2009 |
REMOTE INFRARED THERMOMETER, MODEL RC002 |
RYCOM ELECTRON TECHNOLOGY LIMITED |
Diana Hong |
| K092049 |
10/09/2009 |
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT |
SAINATH INTELLECTUAL PROPERTIES, LLC |
CHRISTOPHER PARADIES |
| K092251 |
10/30/2009 |
BIODENTINE |
SEPTODONT |
WAYNE MATELSKI |
| K083163 |
10/20/2009 |
OMNI 2 OXYGEN SYSTEM |
SEQUAL TECHNOLOGIES, INC. |
BRIAN JARRELL |
| K090823 |
10/22/2009 |
THERAFORM BILAYER |
SEWON CELLONTECH CO., LTD. |
EUGENE BANG |
| K090459 |
10/13/2009 |
DISPOSABLE TPE INFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
Diana Hong |
| K092962 |
10/09/2009 |
CAROTID COIL 5000004901 |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
JIE HUANG |
| K092411 |
10/21/2009 |
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
SHEN WEI (USA), INC. |
ALBERT LI |
| K092691 |
10/15/2009 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SHENG HAOBIN |
| K091216 |
10/09/2009 |
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 |
SIEMENS HEALTHCARE DIAGNOSTICS |
NOOR MALKI |
| K092283 |
10/21/2009 |
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN ANN DRAY-LYONS |
| K091916 |
10/29/2009 |
INNOVANCE D-DIMER, MODEL OPBP09 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN ANN DRAY-LYONS |
| K092919 |
10/23/2009 |
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 |
SIEMENS HEALTHCARE DIAGNOSTICS |
SHANNON POPSON |
| K091984 |
10/28/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
CLARE SANTULLI |
| K092156 |
10/14/2009 |
CAD 12, COLONOSCOPY ASSIST DEVICE |
SOFTSCOPE MEDICAL TECHNOLOGIES, INC. |
BERNARD HORWATH |
| K091420 |
10/14/2009 |
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 |
SOLTA MEDICAL, INC. |
HEATHER MACFALLS |
| K092058 |
10/02/2009 |
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
DAINA L GRAHAM |
| K092895 |
10/19/2009 |
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K092204 |
10/08/2009 |
PMD VIEWER |
SPENCER TECHNOLOGIES |
TONY WILLIAMS |
| K090887 |
10/30/2009 |
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES |
SPINECRAFT |
J.D. WEBB |
| K090650 |
10/09/2009 |
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K083080 |
10/29/2009 |
IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM |
SQI DIAGNOSTICS SYSTEMS |
Kate Smith |
| K092575 |
10/08/2009 |
ENGAGE/ENGAGE TR |
ST. JUDE MEDICAL |
LINH PHAM |
| K092810 |
10/09/2009 |
EP-WORKMATE SYSTEM, VERSION 4.2 |
ST. JUDE MEDICAL |
TIMOTHY J KAPPERS |
| K092876 |
10/16/2009 |
SJM ATTUNE ANNULOPLASTY RING |
ST. JUDE MEDICAL |
THOMAS TADEMACHER |
| K092016 |
10/02/2009 |
SUPER-FINE PEN NEEDLE |
STAT MEDICAL DEVICES, INC. |
MARY L JEAN |
| K092041 |
10/02/2009 |
STELLAR FIDUCIAL MARKER, MODEL GFMIA |
STELLAR MEDICAL LLC. |
BENJAMIN ROEDELL |
| K091174 |
10/27/2009 |
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL |
STERIS Corporation |
ROBERT F SULLIVAN |
| K091606 |
10/23/2009 |
VERTAPLEX HV (SINGLE PACK AND DUAL PACK) |
STRYKER CORP. |
BECKY E DITTY |
| K090542 |
10/23/2009 |
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 |
SUN-RAIN SYSTEM CORP. |
JEN KE-MIN |
| K091574 |
10/09/2009 |
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES |
SUPPLIDORES UNIDOS INTERNACIONALES, S.A. |
VICTOR PEREIRA |
| K092389 |
10/13/2009 |
DISPOSAL ECG ELECTRODES, MODEL EASYRODE |
SUZUKEN CO., LTD. |
KOJI KUBO |
| K091091 |
10/14/2009 |
SONICFILL 2010 |
SYBRON DENTAL SPECIALTIES, INC. |
CLAUDIA ORTIZ |
| K091441 |
10/30/2009 |
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET |
SYNERGETICS, INC. |
GARY OLIVEROS |
| K092082 |
10/02/2009 |
SYNERGY CANNULATED SCREW SYSTEM |
SYNERGY SURGICAL TECHNOLOGIES, LLC |
KEVIN THOMAS |
| K091935 |
10/23/2009 |
LIPIVIEW OCULAR SURFACE INTERFEROMETER |
TEARSCIENCE, INC. |
CHRISTY STEVENS |
| K091761 |
10/29/2009 |
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT |
Teleflex Medical, Inc. |
WILLIAM HEARD |
| K081265 |
10/16/2009 |
THAI NIPPON MALE LATEX CONDOM |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
| K092342 |
10/30/2009 |
SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 |
THE SMARTPILL CORPORATION |
KATHLEEN SELOVER |
| K092757 |
10/09/2009 |
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR |
THERA-TEST LABORATORIES INC. |
MARIUS TEODORESCU |
| K090139 |
10/27/2009 |
ANKLE ARTHRODESIS PLATE SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K092948 |
10/09/2009 |
APLIO MX SSA-780A, VERSION 1.0 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K091332 |
10/02/2009 |
AIA-PACK RBC FOLATE |
Tosoh BioScience, Inc. |
CHARLES P GILL |
| K092604 |
10/21/2009 |
LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX |
TRIMLINE MEDICAL PRODUCTS CORP. |
NANCY SKOCYPEC |
| K082584 |
10/28/2009 |
GIVEN ELECTROSURGICAL NEEDLE |
TRIPPS COURT ENTERPRISES, INC |
JULIE STEPHENS |
| K090841 |
10/05/2009 |
ADDPLUS |
ULRICH GMBH & CO. KG |
MERLE SYMES |
| K092221 |
10/20/2009 |
COLONIC SPLINTING OVERTUBE, MODEL 00711145 |
UNITED STATES ENDOSCOPY GROUP, INC. |
CRAIG L MOORE |
| K091726 |
10/28/2009 |
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 |
USA LASER BIOTECH INC. |
JOYCE HEINRICH |
| K093018 |
10/07/2009 |
G-PROX ENDOSCOPIC GRASPER, MODEL 205333 |
USGI MEDICAL |
MARY L MOONEY |
| K092879 |
10/16/2009 |
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER |
VALLEYLAB |
PHILIP E AKE |
| K092863 |
10/08/2009 |
MAXIFLO, TAPERFLO |
VASCUTEK LTD. |
KAREN KELSO |
| K092103 |
10/09/2009 |
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) |
VATECH CO., LTD. |
VINCENT LEE |
| K091624 |
10/15/2009 |
STENT GRAFT BALLOON CATHETER |
VIA BIOMEDICAL, INC. |
FERNANDO DI CAPRIO |
| K091140 |
10/14/2009 |
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K092280 |
10/16/2009 |
CYPHER DICOM PRINT SOLUTION |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K092492 |
10/21/2009 |
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O |
WEAR SAFE (MALAYSIA) SDN. BHD. |
S H TAN |
| K091516 |
10/16/2009 |
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR |
WELL LEAD MEDICAL CO. LTD |
ARTHUR WARD |
| K092763 |
10/08/2009 |
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K090724 |
10/07/2009 |
OR-LIGHT |
YPERION TECHNOLOGY |
PASCAL DANET |
| K092630 |
10/22/2009 |
ZIROX |
ZENCERA INC |
SANHO HYUN |
| K092711 |
10/01/2009 |
GUARDIAN II HEMOSTASIS VALVE |
ZERUSA LIMITED |
LIAM MULLOY |
| K092109 |
10/09/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
ZHANGJIANGANG ALL FINE RUBBER-PLASTIC PRODUCTS CO. |
|
| K092516 |
10/07/2009 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
ZI BO YUXIANG GLOVES CO., LTD. |
CHU XIAOAN |
| K092403 |
10/30/2009 |
TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 |
ZIMMER DENTAL INC. |
LARISSA D ANDREA MCMULLIN |
| K091566 |
10/28/2009 |
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS |
ZIMMER GMBH |
DANIEL J WILLIMAN |
| K092234 |
10/01/2009 |
DYNESYS TOP-LOADING SPINAL SYSTEM |
ZIMMER SPINE, INC |
ELSA A LINKE |
