FDA 510(k) Decisions During May, 2011  

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
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