FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K102619 |
05/13/2011 |
COMPUTED RADDIOGRAPHY SCANNER |
3DISC AMERICAS |
DANIEL KAMM |
K110302 |
05/19/2011 |
ADHESIVE EXL-759 |
3M ESPE AG |
DESI W SOEGIARTO |
K111257 |
05/13/2011 |
HEISENBERG DYEING LIQUIDS |
3M ESPE AG |
DESI W SOEGIARTO |
K111185 |
05/05/2011 |
RELYX LUTING PLUS AUTOMIX |
3M ESPE DENTAL PRODUCTS |
BERNARDO MEDELLIN, J.D. |
K102568 |
05/06/2011 |
URIC ACID MODEL 3P39 |
ABBOTT LABORATORIES |
LINDA K MORRIS |
K110097 |
05/27/2011 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
KERI YEN |
K103635 |
05/13/2011 |
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S |
AEROGEN LTD |
MARTHA FOLAN |
K103112 |
05/04/2011 |
AFFYMETRIX GENE PROFILING REAGENTS |
Affymetrix, Inc. |
MAUREEN MENDE |
K102860 |
05/10/2011 |
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION |
ALCON RESEARCH, LTD. |
BETH L SCHULTZ |
K110166 |
05/20/2011 |
CLEARCUT S SAFETY KNIFE |
ALCON RESEARCH, LTD. |
TONYA MORGAN |
K111227 |
05/13/2011 |
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
YUKITOSHI KIYOMURA |
K110225 |
05/13/2011 |
ANGIODYNAMICS, INC. VENACURE 1470 LASER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K103174 |
05/06/2011 |
APEX MEDICAL WIZARD SERIES CPAP MASK |
APEX MEDICAL CORP. |
ALAN CHANG |
K110792 |
05/23/2011 |
GELPOINT PATH |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
K110709 |
05/19/2011 |
ARK CARE DIABETES MANAGMENT SYSTEM |
ARKRAY Factory USA, Inc. |
TYLER FOUTCH |
K103421 |
05/24/2011 |
ARSTASIS DILATOR ADAPTER |
ARSTASIS, INC. |
DEBRA COGAN |
K110781 |
05/27/2011 |
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K111042 |
05/26/2011 |
ATRICURE CRYO MODULE |
ATRICURE, INC. |
REBECCA WALTERS |
K102534 |
05/24/2011 |
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE |
AZE, LTD. |
ANDY ANDERSON |
K110413 |
05/11/2011 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
K110251 |
05/25/2011 |
SYNCHRON MULTI CALIBRATOR |
BECKMAN COULTER, INC. |
Yvette Lloyd |
K110771 |
05/13/2011 |
BD SINGLE USE, HYPODERMIC SYRINGE |
Becton, Dickinson and Company |
JOHN ROBERTS |
K102535 |
05/16/2011 |
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML |
BIOMERIEUX SA |
ASA KARLSSON |
K102740 |
05/20/2011 |
NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
K101946 |
05/18/2011 |
VIDAS TOXO IGG AVIDITY |
BIOMERIEUX, INC. |
MARLENE CHAVAROCHE |
K110449 |
05/13/2011 |
ENDOBON XENOGRAFT GRANULES |
BIOMET 3I |
MARTHA I GARAY |
K110574 |
05/18/2011 |
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM |
BIOMET MICROFIXATION, INC. |
SHERYL MALMBERG |
K110039 |
05/03/2011 |
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
K102843 |
05/03/2011 |
MAC MALE ADAPTER |
BIOMET TRAUMA (AKA EBI LLC) |
MARGARET F CROWE |
K101991 |
05/02/2011 |
WEBSTER DUO-DECAPOLAR CATHETER |
BIOSENSE WEBSTER, INC. |
Balaka Das |
K111154 |
05/23/2011 |
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 |
BIOTRONIK, INC. |
Jon Brumbaugh |
K103514 |
05/25/2011 |
PRO-V COAT |
BISCO, INC. |
Michelle Schiltz-Taing |
K103545 |
05/13/2011 |
BT-350 |
BISTOS CO., LTD. |
STEVE KOHN |
K110122 |
05/12/2011 |
MUSTANG BALLOON DILATAION CATHETERS |
BOSTON SCIENTIFIC |
ANNE V ROSSI |
K111295 |
05/31/2011 |
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS |
Boston Scientific Corporation |
MARK MURPHY |
K102251 |
05/17/2011 |
DASH KNEE |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
K102725 |
05/10/2011 |
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M |
BRIDGE MEDICAL, INC. |
JILL MUNSINGER |
K103377 |
05/18/2011 |
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 |
BRIVANT, LTD. |
TOMAS FUREY |
K110396 |
05/06/2011 |
ASPIRA PERITONEAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
K110409 |
05/11/2011 |
ASPIRA PLEURAL DRAINAGE SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
K111153 |
05/24/2011 |
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM |
C.R. BARD, INC. |
ZHENG LIU |
K111056 |
05/03/2011 |
PICCOLO COMPOSITE NAILING SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
K111015 |
05/06/2011 |
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
K103211 |
05/12/2011 |
AVEA VENTILATOR |
CAREFUSION |
FAROKH ETEMADIEH |
K110257 |
05/06/2011 |
DIAMOND-FLEX(R) GRASPERS |
CAREFUSION 2200, INC. |
JANE WEBER |
K111321 |
05/17/2011 |
REMOTE VIEW SOFTWARE |
CARIESCAN LTD. |
NIKOLA SKELLY |
K111164 |
05/06/2011 |
EUNITY |
CLIENT OUTLOOK INC |
CHRISTIE EBY |
K110996 |
05/10/2011 |
BAHA 3 POWER SOUND PROCESSOR |
COCHLEAR AMERICAS |
SEAN BUNDY |
K110751 |
05/09/2011 |
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER |
Codman & Shurtleff, Inc. |
SHARON MCDERMOTT |
K110788 |
05/06/2011 |
INNOVA WHEELCHAIR |
COLUMBIA MEDICAL MANUFACTURING, LLC |
SUSAN JOHNSON |
K110774 |
05/13/2011 |
ELECTRONIC SPHYGMOMANOMETER |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
K110775 |
05/13/2011 |
ELECTRONIC SPHYGMOMANOMETER |
CONTEC MEDICAL SYSTEMS CO., LTD. |
Diana Hong |
K102141 |
05/06/2011 |
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
K102946 |
05/20/2011 |
CORELEADER COLLA-PAD MODEL CS 03030 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
K110321 |
05/25/2011 |
TIGER SPINE SYSTEM |
CORELINK, LLC |
J.D. WEBB |
K110087 |
05/03/2011 |
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS |
CORIN USA |
LUCINDA GERBER |
K103407 |
05/13/2011 |
COTRONIC DIGITAL THERMOMETER |
COTRONIC MANUFACTURING |
YAN DUR LIN |
K110268 |
05/31/2011 |
FORCETRIAD ELECTROSURGICAL GENERATOR |
COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON |
DONALD HENTON |
K102913 |
05/06/2011 |
FORCETRIAD |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
BEN CORDILEONE |
K111099 |
05/05/2011 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
K110642 |
05/27/2011 |
SILJETR SYSTEM |
DANVILLE MATERIALS INC. |
LINDSAY TILTON |
K103653 |
05/26/2011 |
E3 TORQUE CONTROL MOTOR |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
K103364 |
05/06/2011 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL |
DIAMOND DIAGNOSTICS, INC |
LIANN VOO |
K110188 |
05/17/2011 |
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
K110384 |
05/03/2011 |
DILON 6800 ACELLA (ACELLA) |
DILON TECHNOLOGIES, INC. |
ELAINE DUNCAN |
K101763 |
05/09/2011 |
DIOPSYS NOVA VEP VISION TESTING SYSTEM |
DIOPSYS INC. |
RICHARD HETTENBACH |
K100895 |
05/27/2011 |
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) |
DIPPED PRODUCTS LIMITED |
W.S.E.F. FERNANDO |
K110593 |
05/05/2011 |
OWL RF PROBES |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
K103094 |
05/17/2011 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
MARGUERITE THOMLINSON |
K103801 |
05/20/2011 |
HYPOTHERMX INTRAVENOUS FLUID WARMER |
EMIT CORPORATION |
DARLA J ELKIN |
K110090 |
05/26/2011 |
AFX INTRODUCER SYSTEM |
ENDOLOGIX, INC. |
Janet M Fauls |
K101037 |
05/23/2011 |
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 |
EPS BIO TECHNOLOGY CORP. |
YC LEI |
K110706 |
05/17/2011 |
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
K103067 |
05/20/2011 |
EXSALT SD7 WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
ROD PRECHT |
K101128 |
05/26/2011 |
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 |
FILLIGENT LIMITED |
IAN GORDON |
K111243 |
05/16/2011 |
FUJINON ULTRASONIC PROCESSOR |
FUJINON INC. |
KATHERINE Y CHOI |
K102466 |
05/25/2011 |
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR |
FUJINON, INC. |
CURTIS RAYMOND |
K100831 |
05/26/2011 |
CYFRA 21-1 EIA MODEL 211-10 |
FUJIREBIO DIAGNOSTICS, INC |
STACEY DOLAN |
K110641 |
05/27/2011 |
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL |
FUJIREBIO DIAGNOSTICS, INC |
JOHN GORMLEY |
K103832 |
05/20/2011 |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
K110875 |
05/05/2011 |
CENTRICITY PACS |
GE HEALTHCARE |
CHERYL BORK |
K110573 |
05/03/2011 |
READY VIEW |
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) |
ELIZABETH MATHEW |
K103633 |
05/11/2011 |
ACHILLES |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
CHRIS PAULIK |
K103765 |
05/17/2011 |
MAC 600 RESTING ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
JOE LUCAS |
K110132 |
05/25/2011 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
K103730 |
05/06/2011 |
GE LUNAR VISCERAL FAT SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
CHRIS PAULIK |
K102307 |
05/04/2011 |
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS |
GENOSS CO., LTD. |
EUNKYUNG SON |
K103025 |
05/13/2011 |
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES |
GIVEN IMAGING LTD. |
Tim Thomas |
K110963 |
05/05/2011 |
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER, PH.D |
K103382 |
05/20/2011 |
INTERCONTINENTAL PLATE-SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
K110932 |
05/03/2011 |
TINNITUS SOUND GENERATOR MODULE |
GN RESOUND A/S |
LARS HAGANDER |
K110182 |
05/20/2011 |
CANNABINOIDS URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K102970 |
05/20/2011 |
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
K111102 |
05/05/2011 |
RADIOVISION |
HAAS SOFTWARE |
DAVID L STARK |
K102922 |
05/04/2011 |
HARDYCHROM MRSA |
HARDY DIAGNOSTICS |
RENE CLASEN |
K111163 |
05/17/2011 |
CHITOGAUZE FUSION |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KENDRA RATHKEY |
K102598 |
05/13/2011 |
HI-DOW-XP |
HI-DOW INTERNATIONAL INC. |
ERIC CHEN |
K100987 |
05/13/2011 |
INVADER MTHFR 677 |
HOLOGIC, INC. |
RANDALL COVILL |
K103835 |
05/05/2011 |
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
K110985 |
05/03/2011 |
ICON ADULT MANUAL |
ICON WHEELCHAIRS INC |
TOM HORTON |
K103207 |
05/20/2011 |
JBAIDS Q FEVER DETECTION KIT |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
K111098 |
05/27/2011 |
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN |
IMAGING DYNAMICS COMPANY LTD. |
DANIEL KAMM |
K110369 |
05/06/2011 |
INDISTRIP GREEN |
INDILAB, INC. |
MARK ESPENSCHEID |
K110528 |
05/11/2011 |
INTEGRA LED SURGICAL HEADLIGHT SYSTEM |
INTEGRA LIFE SCIENCES CORPORATION |
STEPHANIE SHEESLEY |
K110015 |
05/20/2011 |
VITALSENS, AINGEAL, V-POD |
INTELESENS LIMITED |
PAUL DRYDEN |
K111001 |
05/17/2011 |
STERILE STORM (R) OPERATING KIT |
INTELLIGENT ORTHOPAEDICS LTD |
PETER J OGRODNIK |
K103760 |
05/05/2011 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
K103523 |
05/11/2011 |
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
K103525 |
05/11/2011 |
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
K110454 |
05/13/2011 |
COUGAR LS LATERAL CAGE SYSTEM |
JOHNSON & JOHNSON |
KEVIN G STEVENS |
K101585 |
05/10/2011 |
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER |
JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR |
BRAD LAMOTTE,PHARM.D. |
K101779 |
05/16/2011 |
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM |
JPI HEALTHCARE CO., LTD |
WILLIAM LITTLE |
K103797 |
05/20/2011 |
K2M COCR WIRE |
K2M, INC. |
NANCY GIEZEN |
K102935 |
05/27/2011 |
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A |
KINGTECH ENTERPRISE, LTD. |
JEN KE-MIN |
K111064 |
05/18/2011 |
TIGERPAW SYSTEM II |
LAAX, INC. |
MICHAEL A DANIEL |
K101158 |
05/06/2011 |
LIC INSTRUMENT PROCESSING SYSTEM |
LANGFORD IC SYSTEMS, INC. |
TERRY LANGFORD |
K102463 |
05/25/2011 |
GOOD NIGHT |
LARRY V CONNELL, DMD |
EILEEN CONNELL |
K103771 |
05/06/2011 |
LOTUS BLAKE ESTEEM SCOOTER |
LETRIX POWER HANGZHOU PTY LTD |
ROBERT DUNN |
K110233 |
05/27/2011 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CASPER E ULDRIKS ESQ. |
K111384 |
05/24/2011 |
LIFEBRIDGE |
LIFEBRIDGE MEDIZINTECHNIK AG |
KATHLEEN JOHNSON |
K100567 |
05/10/2011 |
PEARL DIABETES MANAGEMENT SYSTEM |
M2 GROUP HOLDINGS, INC. |
NAGHMEH NOURI |
K102845 |
05/13/2011 |
MAHE FIXATION PLATE AND SCREW SYSTEM |
MAHE MEDICAL GMBH |
ANDREA PECSI |
K102182 |
05/09/2011 |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 |
MAQUET CRITICAL CARE AB |
WHITNEY TORNING |
K110578 |
05/20/2011 |
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM |
MAR COR PURIFICATION, INC. |
Brent Geiger |
K110415 |
05/16/2011 |
SIGNATURE PLANNER / SIGNATURE GUIDES |
MATERIALISE N.V. |
ALEXANDRA RAZZHIVANA |
K102263 |
05/05/2011 |
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 |
MCKESSON INFORMATION SOLUTIONS LLC |
STEVEN B DATLOF |
K111283 |
05/27/2011 |
GMK REVISION HYBRID LINERS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K092338 |
05/27/2011 |
MEDAX UNIPERSONALE SRL |
MEDAX UNIPERSONALE SRL |
FLAVIO TOMASSINI |
K101090 |
05/20/2011 |
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS |
MEDICA CORP. |
Photios Makris |
K110159 |
05/12/2011 |
ACTIVECARE SFT |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
ORLY MAOR |
K083423 |
05/17/2011 |
COLONCAD API 3.1 |
MEDICSIGHT PLC |
AMARJIT GILL |
K103718 |
05/10/2011 |
DYNACOR LUBRICATION GEL |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K111182 |
05/24/2011 |
ANGIOJET SOLENT OMNI THROMBECTOMY SET |
MEDRAD, INC. |
Doug Atkins |
K110386 |
05/10/2011 |
CELOX RAPID GAUZE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
K103764 |
05/04/2011 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
YUKIKO CORSON |
K110676 |
05/23/2011 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
KEVIN FORD |
K110283 |
05/19/2011 |
ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
K110620 |
05/03/2011 |
PREMIER C. DIFFICILE GDH |
MERIDIAN BIOSCIENCE, INC. |
SUSAN BOGAR |
K102342 |
05/05/2011 |
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT |
MICROPHAGE, INC. |
DREW SMITH |
K110121 |
05/10/2011 |
WEXLER ENDOSCOPE ACCESSORIES |
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
LISA S JONES |
K110358 |
05/05/2011 |
VENODYNE V810 |
MICROTEK MEDICAL, INC. |
TOM BONNER |
K111137 |
05/20/2011 |
HYDROFIX VASO SHIELD |
MIMEDX GROUP INC |
SALLY THORSEN |
K100130 |
05/16/2011 |
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 |
MITSUBISHI CHEMICAL MEDIENCE CO |
Judi Smith |
K110976 |
05/03/2011 |
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM |
NANOTHERAPEUTICS, INC. |
DENNIS TOMISAKA |
K103589 |
05/13/2011 |
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
NATUS MEDICAL INCORPORATED |
JULIE FREED |
K110628 |
05/12/2011 |
SIMPLEABI |
NEWMAN MEDICAL |
SPENCER NEWMAN |
K092801 |
05/20/2011 |
ABS BLOWER, ABS NOZZLE, MODEL 1001 |
NIMBIC SYSTEMS, LLC |
SEAN SELF |
K110484 |
05/17/2011 |
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
K103312 |
05/12/2011 |
UPD-Y0003 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY KLUESNER |
K110006 |
05/18/2011 |
OIS SYMPHONY IMAGE MANAGMENT SYSTEM |
OPHTHALMIC IMAGING SYSTEMS |
ANDREA AMBROSE |
K110986 |
05/16/2011 |
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 |
OPTOMED OY |
LAURA PIILA |
K110335 |
05/19/2011 |
CERAMIC BRACKETS |
ORTHO ORGANIZERS, INC. |
FOSTER BOOP |
K111183 |
05/24/2011 |
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) |
ORTHOFIX INC. |
DARLA CHEW |
K102208 |
05/06/2011 |
NANOGEN |
ORTHOGEN, LLC |
HAROLD ALEXANDER |
K110256 |
05/27/2011 |
THE IC-PRO SYSTEM |
PAIEON, INC. |
EREZ BEN-ZVI |
K110430 |
05/11/2011 |
DOLPHIN IMAGING |
PATTERSON DENTAL SUPPLY, INC. |
DAWN LI |
K103775 |
05/27/2011 |
PEAK SUCTION COAGULATOR |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
K102887 |
05/16/2011 |
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 |
PERCUTANEOUS SYSTEMS, INC. |
THOMAS LAWSON, PHD |
K110214 |
05/27/2011 |
DIRECTVISION CATHETER, UNCOATED |
PERCUVISION |
FIDES MALDONADO |
K101251 |
05/27/2011 |
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
PHADIA AB |
MARTIN MANN |
K111336 |
05/24/2011 |
EBW NM 2.0 |
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
LORI R PETERSON |
K111114 |
05/20/2011 |
SURESIGNS VS2 VITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS |
KRISTEN LESSARD |
K110803 |
05/20/2011 |
SURESIGNS VSI VITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
K110588 |
05/25/2011 |
LEUCADIA PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
K110692 |
05/12/2011 |
STREAMLINE TL SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. |
EMILY M DOWNS |
K110473 |
05/25/2011 |
NANOTACK SUTURE ANCHOR 1.4MM |
PIVOT MEDICAL |
Jon Cook |
K110102 |
05/13/2011 |
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG |
PREVENTIVE CARE, INC. |
ANIL SEGAT |
K102894 |
05/25/2011 |
CLASSIX CHEMICAL STERILIZATION INDICATOR |
PROPPER MFG. CO., INC. |
ANDREW SHARAVARA |
K111121 |
05/13/2011 |
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH |
PROXY BIOMEDICAL LTD. |
ELAINE DUNCAN |
K103744 |
05/12/2011 |
DROPPER A1C DIABETES CONTROL |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
K092268 |
05/25/2011 |
RANDOX BARITURATES ASSAY |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K092266 |
05/09/2011 |
RANDOX METHAMPHETAMINE ASSAY |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K102748 |
05/13/2011 |
31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
K110722 |
05/17/2011 |
RPS ADENO DETECTOR PLUS |
RAPID PATHOGEN SCREENING, INC. |
Douglas Bueschel |
K110965 |
05/11/2011 |
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
DAVID J COLLETTE, MD |
K102512 |
05/20/2011 |
RMS SUBCUTANEOUS NEEDLE SET |
REPRO-MED SYSTEMS, INC. |
ANDREW SEALFON |
K110613 |
05/12/2011 |
ELECSYS PROLACTIN II CALCHECK 5 |
Roche Diagnostics |
KELLY COLLEEN O'MAINE ADAMS |
K103716 |
05/12/2011 |
ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET |
Roche Diagnostics |
KATHIE J GOODWIN |
K110446 |
05/03/2011 |
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID |
Roche Diagnostics |
MICHELLE LEE NEFF |
K110230 |
05/19/2011 |
ROG KNOTLESS SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
K110229 |
05/18/2011 |
ROG SUTURE ANCHOR 5.5MM, 2.9MM |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
K110495 |
05/20/2011 |
LIFTKAR PT |
SANO TRANSPORTGERATE GMBH |
JEANINE A CARROCCIO |
K103812 |
05/18/2011 |
MITRA-LIFT |
SCIENCITY CO., LTD |
JOYCE BANG |
K102026 |
05/12/2011 |
SEASPINE SPACER SYSTEM |
SEASPINE, INC. |
DAN MILLER |
K100547 |
05/19/2011 |
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
K100263 |
05/06/2011 |
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
SEPPIM S.A.S. |
DEBRA K HUTSON |
K102993 |
05/19/2011 |
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
K102328 |
05/13/2011 |
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
K103560 |
05/18/2011 |
SHASER IPL HAIR REMOVAL SYSTEM |
SHASER, INC. |
GLEN EMELOCK |
K110235 |
05/13/2011 |
BEAUTIBOND MULTI |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
K110252 |
05/13/2011 |
BEAUTIBOND MULTI PR PLUS |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
K110905 |
05/24/2011 |
TOTAL SHOULDER SYSTEM |
SHOULDER INNOVATIONS, LLC |
ANDREW RODENHOUSE |
K103723 |
05/20/2011 |
SICAT IMPLANT V1.2 |
SICAT GMBH & CO. KG |
MARK W SHEEHAN |
K111079 |
05/13/2011 |
SYNGO.VIA WEB VIEWER |
SIEMENS AG, MEDICAL SOLUTIONS |
SVEN KNOKE |
K102510 |
05/13/2011 |
DIMENSIONS HB1C KIT, MODEL DF105A |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE ENNIS |
K110303 |
05/16/2011 |
STRATUS CS ACUTE CARE D-DIMER |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN ANN DRAY-LYONS |
K102681 |
05/04/2011 |
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) |
Siemens Healthcare Diagnostics Inc. |
MATTHEW GEA |
K100910 |
05/11/2011 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
DONNA VELASQUEZ |
K111052 |
05/20/2011 |
SYNGO NEURO PBV-IR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY L JOHNSON |
K111330 |
05/27/2011 |
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY |
SKANRAY TECHNOLOGIES |
PARASURAMAPPA BELUR |
K102317 |
05/17/2011 |
IQ VENTILATION NASAL MASK |
SLEEPNET CORPORATION |
PAUL DRYDEN |
K101155 |
05/12/2011 |
AURADORM (NEUROMUSCULAR SLEEP) |
SLEEPWRIGHT |
CYNTHIA WRIGHT |
K103793 |
05/02/2011 |
DURAFIBER AG |
Smith & Nephew, Inc |
TERRY MCMAHON |
K110349 |
05/03/2011 |
CLEAR+BRILLIANT LASER SYSTEM |
SOLTA MEDICAL, INC. |
KRISTINE FOSS |
K110510 |
05/16/2011 |
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
K102199 |
05/23/2011 |
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) |
SOPHONO, INC |
CLAY ANSELMO |
K110433 |
05/12/2011 |
CLEARBLUE EASY PREGNANCY TEST |
SPD DEVELOPMENT COMPANY LIMITED |
TANYA FAIR |
K110957 |
05/31/2011 |
M4 MONITOR |
SPECTRUM MEDICAL, LLP |
STEVE TURNER |
K110450 |
05/10/2011 |
AGILIS NXT STEERABLE INTRODUCER |
ST. JUDE MEDICAL |
WENDY PINOR |
K110549 |
05/05/2011 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
K110718 |
05/26/2011 |
CELL-CHEX WITH CPPD CRYSTALS |
Streck |
Deborah Kipp |
K110807 |
05/25/2011 |
ABG II MONOLITHIC HIP STEM |
STRYKER CORP. |
STEPHANIE FITTS |
K110533 |
05/19/2011 |
STRYKER PATIENT SPECIFIC CUTTING GUIDE |
STRYKER CORP. |
KAREN ARIEMMA |
K103692 |
05/25/2011 |
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
DANIEL DONOVAN |
K111230 |
05/24/2011 |
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW |
SYNTHES (USA) PRODUCTS LLC |
REBECCA BLANK |
K103822 |
05/19/2011 |
SYNTHES HEMOSTATIC BONE PUTTY (HBP) |
SYNTHES USA PRODUCTS, LLC |
JEFFREY L DOW |
K102049 |
05/27/2011 |
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
K110948 |
05/13/2011 |
HEALTH CARE SYSTEM SOFTWARE |
TaiDoc Technology Corporation |
TELING HSU |
K110146 |
05/13/2011 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
TANGSHAN KAIYUE GLOVE CO., LTD. |
CHU XIAOAN |
K110155 |
05/23/2011 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
TANGSHAN XIANGRUI PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K110422 |
05/26/2011 |
SURGICAL STIMULATORS |
TECHNOMED EUROPE |
PIERRE VREULS |
K110540 |
05/13/2011 |
TERUMO SUPPORT CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K110746 |
05/24/2011 |
4D LV-ANALYSIS 3.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
K110489 |
05/23/2011 |
SLIT LAMP SL-2G |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
K094013 |
05/05/2011 |
HLS KNEETEC SYSTEM |
TORNIER |
SEVERINE BONNETON |
K102788 |
05/10/2011 |
TORNIER BIOFIBER SCAFFOLD |
TORNIER, INC. |
LAEL J PICKETT |
K111251 |
05/27/2011 |
4CH FLEX SPEEDER |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
PAUL BIGGINS |
K110785 |
05/27/2011 |
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
PAUL BIGGINS |
K111234 |
05/13/2011 |
CLICK-IT |
TP ORTHODONTICS, INC. |
ROBIN INTAGLIATA |
K110314 |
05/10/2011 |
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) |
TRUE GLOVE FACTORY |
FRANK YANG |
K101952 |
05/27/2011 |
KONIX ULTRASOUND GEL |
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
MICHAEL SCOTT |
K081868 |
05/25/2011 |
SMART LEISH, MODEL LGM1-050 |
U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS |
ROBER MILLER |
K110447 |
05/27/2011 |
ECHOINSIGHT |
ULTRASOUND MEDICAL DEVICES, INC. |
PAUL KORTESOJA |
K103510 |
05/06/2011 |
UNIMAX SPECIMEN RETRIEVAL SYSTEM |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
K103509 |
05/19/2011 |
UNIMAX SUCTION IRRIGATION SET |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
K103611 |
05/09/2011 |
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
K110438 |
05/04/2011 |
SENSILASE PAD-IQ |
VASAMED, INC. |
Gary J Syring |
K110226 |
05/27/2011 |
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE |
VERTEBRAL TECHNOLOGIES, INC. |
SURESH GHAI |
K102733 |
05/18/2011 |
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR |
VISION-SCIENCES, INC. |
LILLIAN QUINTERO |
K110589 |
05/27/2011 |
CIMARA |
VOCO GMBH |
MANFRED T PLAUMANN |
K110440 |
05/04/2011 |
QUICK UP |
VOCO GMBH |
DR. T. GERKENSMEIER |
K110853 |
05/13/2011 |
VR MEDICAL ENTERAL ORAL SYRINGE |
VR MEDICAL |
LEE PAN |
K103500 |
05/23/2011 |
GORE EMBOLIC FILTER |
W.L. GORE & ASSOCIATES,INC |
MICHELLE A WELLS |
K110973 |
05/05/2011 |
IE-ZEN (IN CLEAR SERIES HEARING AID) |
WIDEX USA |
FRANCIS KUK |
K110872 |
05/20/2011 |
WITHINGS BLOOD PRESSURE MONITOR |
WITHINGS |
JEN KE-MIN |
K102324 |
05/04/2011 |
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
K110399 |
05/10/2011 |
GLADIATOR PLASMA CLASSIC HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K103603 |
05/20/2011 |
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
K101681 |
05/27/2011 |
TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
K102191 |
05/02/2011 |
TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
K111039 |
05/19/2011 |
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
K110978 |
05/13/2011 |
ONESTEP PEDIATRIC MFE'S |
ZOLL MEDICAL CORPORATION |
ROBERT MORSE |
K103473 |
05/13/2011 |
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |