FDA 510(k) Decisions During June, 2008  

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
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