FDA 510(k) Decisions During May, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K090317 05/20/2009 BABI*PLUS BUBBLE PAP VALVE A PLUS MEDICAL THOMAS C LOESCHER
K090665 05/22/2009 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE TAYLOR
K091146 05/01/2009 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K091326 05/27/2009 ACTIVAPATCH ACTIVATEK INC. JAMAL YANAKI
K082612 05/05/2009 GBS PNA FISH ADVANDX, INC. PAULA E BULGER
K080868 05/14/2009 AONGEN COLLAGEN MATRIX AEON ASTRON EUROPE B.V. HORNG J LAI
K090354 05/12/2009 LAMINOPLASTY PLATING SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K083214 05/12/2009 AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 AGA MEDICAL CORP. DIANE CARROLL
K090672 05/18/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K082529 05/01/2009 ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K082858 05/27/2009 EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER ALCAVIS INTERNATIONAL, INC. GARY J MISHKIN
K090024 05/04/2009 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, LLC MICHAEL RENNER
K083628 05/01/2009 GLUCODR AUTO SYSTEM ALL MEDICUS CO., LTD MARGARET KIM
K083507 05/18/2009 BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K090356 05/20/2009 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K083385 05/14/2009 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K090425 05/19/2009 GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K083102 05/11/2009 REFINE LIFT SYSTEM ALURE MEDICAL INC. JASPER BENKE
K090943 05/27/2009 ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K090432 05/29/2009 HEMORPEX SYSTEM ANGIOLOGICA B. M. SRL ROBERTO MANCO
K083729 05/08/2009 HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN ANIARA DIAGNOSTICA ,LLC OLA ANDERSON
K090676 05/22/2009 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES ANTHOGYR BRAYETTE SABINE
K082436 05/29/2009 EXTT-101 APIMEDS, INC KEVIN WALLS
K091133 05/20/2009 APLION TOPICAL CARE SYSTEM APLION MEDICAL,LLC CURTIS JENSEN
K091172 05/05/2009 NIO 2MP (MDNG-2121) BARCO NV LIEVEN DE WANDEL
K082589 05/22/2009 BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 BAROSENSE, INC DANIEL J BALBIERZ
K090413 05/14/2009 A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC BAYER HEALTHCARE, LLC CATHY PETERS
K090588 05/27/2009 POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 BECKMAN COULTER, INC. MARY B TANG
K090827 05/27/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K090409 05/08/2009 BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES DAVID V BHEND
K090793 05/19/2009 BONGROS HA BIOALPHA, INC. HYUN-SEUNG RYU
K090208 05/22/2009 BIOPRO FEMORAL HEADS BIOPRO, INC. DAVID MRAK
K090424 05/14/2009 DVX SPINE SYSTEM BK MEDITECH CO., LTD. ELAINE DUNCAN
K071004 05/21/2009 OSTEOCRETE BONE VOID FILLER BONE SOLUTIONS, INC. CHRISTINE EMANUEL
K091131 05/08/2009 PELVIC FLOOR REPAIR SYSTEM BOSTONSCIENTIFIC MICHELLE BERRY
K082060 05/08/2009 CRANIAL IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG RAINER BIRKENBACH
K090005 05/19/2009 BRANEMARK INTEGRATION BIOHELIX IMPLANTS BRANEMARK INTEGRATION AB AGNETA SVENSSON
K090113 05/14/2009 BREAS VIVO 40 SYSTEM BREAS MEDICAL AB BIRGITTA BOLANDER
K081130 05/14/2009 BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K091160 05/05/2009 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM BRONCUS TECHNOLOGIES, INC. MAHTAB FATEMI
K090528 05/28/2009 DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT C.R. BARD, INC. JI HYUN KIM
K091042 05/12/2009 CRONO S-PID 50 CANE S.R.L. CARLO MUSSO
K091435 05/29/2009 DIGITAL RADIOGRAPHY MODEL CXDI-55G CANON INC. SHEILA DRISCOLL
K091436 05/29/2009 DIGITAL RADIOGRAPHY, MODEL CXDI-55C CANON, INC. SHEILA DRISCOLL
K090486 05/06/2009 ASTHMA MONITOR MODEL, AM1 CARDINAL HEALTH GERMANY 234 GMBH THOMAS GUTIERREZ
K091250 05/22/2009 DIAGNOSTIC CATHETER SYSTEM CARDINAL HEALTH, INC. SHARON NICHOLS
K090602 05/28/2009 CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS CARDIODYNAMICS INTERNATIONAL CORP. DON BROOKS
K090469 05/22/2009 CARESTREAM DRYVIEW 5850 LASER IMAGER CARESTREAM HEALTH, INC. GAYLE CARROLL
K083291 05/05/2009 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K082134 05/07/2009 CIRCULATOR BOOT CIRCULATOR BOOT CORP. RICHARD S DILLON
K083499 05/08/2009 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS COLOPLAST A/S JANELL A COLLEY
K091152 05/07/2009 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 COLOPLAST A/S ANGELA BYLAND
K090335 05/06/2009 HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. LARAINE PANGELINA
K091139 05/05/2009 CONMED AER DEFENSE SMOKE EVACUATOR CONMED CORPORATION DEMARIS VELEZ
K090470 05/14/2009 AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES COVIDIEN JENNIFER BRENNAN
K091050 05/27/2009 506CN PATIENT MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K091169 05/13/2009 ELITE MPX LASER SYSTEM WITH CRYO C CYNOSURE, INC. ANTHONY BURNS
K081286 05/08/2009 MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 DAKO NORTH AMERICA, INC. KELLY MILLER
K091068 05/08/2009 ACCUTORR V MONITOR, MODEL 0998-00-2000 DATASCOPE CORP., PATIENT MONITORING DIVISION KATHLEEN KRAMER
K083805 05/22/2009 ANKYLOS C/X DENTAL IMPLANT SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K081917 05/22/2009 DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS DEPUY SPINE, INC. SHARON STAROWICZ
K090899 05/19/2009 DEPUY SPINE LATERAL SYSTEM DEPUY SPINE, INC. DENISE DUCHENE
K090458 05/28/2009 DEXIS SENSOR DEXIS LLC CLAUDIA ORTIZ
K083391 05/21/2009 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K090062 05/18/2009 WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC DIANA HONG
K091358 05/28/2009 ECSCOPE 100 DYANSYS, INC. SRINI NAGESHWAR
K083821 05/14/2009 VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. WILLIAM STERN
K083648 05/14/2009 GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL EFRATGO, LTD. HI TECH BIO-SURGICAL GEORGE J HATTUB
K080355 05/01/2009 LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS ELEKTA INSTRUMENT AB PETER LOWENDAHL
K082834 05/07/2009 ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC ELLMAN INT'L INC. RICK EPSTEIN
K090717 05/08/2009 FLEX-TENS EMSI CHERITA JAMES
K090979 05/28/2009 DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES ENCISION, INC. JUDITH V KING
K083833 05/22/2009 ENABLER-P CATHETER, 1000 PART NUMBER:1160 ENDOCROSS, LTD. JOHN SMITH
K091009 05/18/2009 MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 ESAOTE S.P.A. ALLISON SCOTT
K083850 05/20/2009 EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS EUROIMMUN US INC KATHRYN KOHL
K090849 05/01/2009 MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 EV3 INC. SARA BAKKAR
K091194 05/18/2009 ALGISEAL PAD EVOLUTION MEDICAL TECHNOLOGIES LLC JOHN MANNING
K090266 05/06/2009 MATCHEDFLICKER EYEIC CORPORATION MORRIS WAXLER
K091119 05/15/2009 MODIFICATION TO THE CROSSER SYSTEM FLOWCARDIA, INC. DUSTIN MICHAELS
K091254 05/29/2009 THE CROSSER 14 OTW CATHETER, MODEL CRU014 FLOWCARDIA, INC. DUSTIN MICHAELS
K083838 05/12/2009 SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES FOOK TIN TECHNOLOGIES LIMITED JOHN CHAI
K090559 05/04/2009 FOOTPRINT MEDICAL SILICONE FEEDING TUBE FOOTPRINT MEDICAL CLYDE BAKER
K082781 05/01/2009 OEC 9900 ELITE GE HEALTHCARE SURGERY MARIA C FRAME
K091374 05/26/2009 GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K091164 05/05/2009 GE VENUE 40, MODEL 5324338 GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K090428 05/07/2009 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC GENESEE BIOMEDICAL, INC. JOHN WRIGHT
K081938 05/01/2009 ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 GENZYME DIAGNOSTICS P.E.I. INC. PENNY J WHITE
K083156 05/08/2009 NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE GIGA-DRIVE SDN, BHD IAN NG TZE CHEU
K081640 05/06/2009 GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS GIMMI GMBH KEN BLAKE
K082403 05/15/2009 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT GISH BIOMEDICAL, INC. HARVEY KNAUSS
K082455 05/22/2009 RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER GULF COAST HYPERBARICS, INC. JAMES W MCCARTHY
K090365 05/07/2009 HANSEN MEDICAL ARTISAN S CONTROL CATHETER HANSEN MEDICAL, INC. KATE WHITIN
K091107 05/01/2009 MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM HEMOSTATIX MEDICAL TECHNOLOGIES, LLC JEFF COBB
K090957 05/28/2009 BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM I2S MICRO IMPLANTABLE SYSTEMS, LLC GARY SYRING
K090234 05/15/2009 SPECTRA SYSTEM DENTAL IMPLANTS 2008 IMPLANT DIRECT LLC THOMAS GOTTENBOS
K083480 05/05/2009 INCLUSIVE ZIRCONIA ABUTMENT BLANKS INCLUSIVE DENTAL SOLUTIONS KEITH D ALLRED
K090677 05/07/2009 INNOPORT LAPAROSCOPIC ACCESS DEVICE INNOVIA LLC BRUCE WEBER
K090421 05/29/2009 MODEL 350G GAS CONSERVER INSPIRED TECHNOLOGIES, INC. PAUL DRYDEN
K082111 05/22/2009 STRAUMANN MEMBRAGEL INSTITUT STRAUMANN AG LISA QUAGLIA
K090864 05/08/2009 CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K082419 05/27/2009 REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 INTRA-LOCK INTERNATIONAL, INC. JEFFREY SAKOFF
K082497 05/07/2009 INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT INTUITIVE SURGICAL, INC. JAMES FARNWORTH
K083751 05/21/2009 INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 INVACARE CORPORATION CARROLL MARTIN
K083851 05/15/2009 INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K090078 05/08/2009 KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT IOP, INC. JASON MALECKA
K090363 05/08/2009 ZIO PATCH, MODEL Z100 IRHYTHM TECHNOLOGIES, INC. WILLIAM H RIGHTER
K091145 05/27/2009 FLEXIPLAN 3D AND 3D+ ISODOSE CONTROL B.V. HUB VAN DE BERGH
K090826 05/11/2009 MONOBOND PLUS IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K090052 05/29/2009 CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C JOHARI DIGITAL HEALTHCARE, LTD. NISHA JOHARI
K081122 05/26/2009 FUSION MEDICAL CANNULATED SCREW SYSTEM JOHN RICCIO JOHN RICCIO
K081755 05/20/2009 FUSION MEDICAL STI JOHN RICCIO JOHN RICCIO
K083598 05/29/2009 KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K090489 05/14/2009 ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 KCI USA, INC. CHRISTY H OVIATT
K091023 05/21/2009 METAMORPHOSIS KERR CORPORATION WENDY GARMAN
K082824 05/27/2009 FLUID FILLED TEETHER KIDS II BILL YUNG
K082554 05/01/2009 KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 KIMBERLY-CLARK CORP. LISA PEACOCK
K083822 05/06/2009 LASER TOUCHONE LASER HEALTH TECHNOLOGIES, LLC PATSY TRISLER
K083253 05/15/2009 LOTUS II PULSED ER: YAG LASER SYSTEM LASEROPTEK CO. LTD. PHILLIP CHEON
K090815 05/21/2009 PERCUTANEOUS DISCECTOMY SYSTEM LAURIMED LLC SEVRINA CIUCCI
K090531 05/27/2009 RADCALC SOFTWARE, VERSION 6.0 LIFELINE SOFTWARE, INC. RICHARD VINCINS
K083733 05/04/2009 LUME 2 SYSTEM, MODEL GA0005000 LUMENIS, LTD. FRANCES HARRISON
K090092 05/11/2009 SOCKIT! AND MCMERLIN DERMAL WOUND GEL MCMERLIN DENTAL PRODUCTS LP AARON HENDERSHOTT
K091257 05/08/2009 MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM MEDI-GLOBE CORPORATION SCOTT KARLER
K083455 05/18/2009 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 MEDI-KHAN USA, INC JULIE SANTIAGO
K090037 05/22/2009 MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG MEDICALGORITHMICS SP Z.O.O. MARTIN JASINSKI
K090834 05/15/2009 EPICARDIA 5000 MEDICOMP, INC. SUSAN D GOLDSTEIN-FALK
K090390 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K090833 05/12/2009 SEGMENT MEDVISO EINAR HEIBERG
K090700 05/28/2009 IMMUNOCARD STAT CAMPY, MODEL 751530 MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K090870 05/01/2009 ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K091040 05/13/2009 MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN GOLDSTEIN-FALK
K083922 05/06/2009 MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K072288 05/06/2009 PATHFAST D-DIMER MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K081509 05/01/2009 MONTERIS MEDICAL AUTOLITT LASER PROBE MONTERIS MEDICAL CRAIG COOMBS
K083441 05/22/2009 FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION MOTION MEDICAL PRODUCTS LLC GARY BUSSETT
K083088 05/01/2009 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC GREGORY W SHIPP
K091261 05/12/2009 NMI PICC NAVILYST MEDICAL, INC. NICHOLAS CONDAKES
K090452 05/22/2009 NEOSS IMPLANT SYSTEM 03.25 NEOSS LTD CHERITA JAMES
K083322 05/27/2009 NEUROMETRIX BIOAMPLIFIER NEUROMETRIX, INC. RAINER MAAS
K090042 05/06/2009 PAINMASTER MCT PATCH NEWMARK, INC. DEBORAH LIVORNESE
K090069 05/07/2009 PROCERA IMPLANT BRIDGE OVERDENTURE NOBEL BIOCARE AB HERBERT CRANE
K090182 05/04/2009 MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) NUCLEMED S.A. RAYMOND KELLY
K091154 05/18/2009 UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, NUCLETRON CORPORATION ELAINA COLBY
K091071 05/08/2009 NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. HAN FAN
K090725 05/20/2009 OCULUS MICROCYN WOUND GEL OCULUS INNOVATIVE SCIENCES, INC. ANTIOINETTE DOUGLAS
K083184 05/14/2009 TEARLAB OSMOLARITY SYSTEM OCUSENSE, INC. JANICE M HOGAN
K083633 05/01/2009 HS II SHORT FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K090440 05/20/2009 HINGE PEDIATRIC PLATING SYSTEM PEGA MEDICAL INC. ARIEL DUJOVNE
K090288 05/05/2009 ORTHADAPT PR PEGASUS BIOLOGICS, INC. AMY BOUCLY
K090196 05/19/2009 EG-3670URK PENTAX MEDICAL COMPANY PAUL SILVA
K090197 05/19/2009 EG-3870UTK PENTAX MEDICAL COMPANY PAUL SILVA
K090262 05/28/2009 PERCUCATH URINARY CATHETER PERCUVISION LLC ERROL SINGH
K083117 05/28/2009 ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 PHADIA US INC. MARTIN ROBERT MANN
K091195 05/27/2009 PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MICHAEL CHILBERT
K090360 05/04/2009 PHILIPS M3001A MULTI MEASUREMENT SERVER PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH JENS-PETER SEHER
K091269 05/08/2009 NEUROPET PHOTODETECTION SYSTEMS, INC. STEWART TUTTLE
K091099 05/22/2009 C-PORT - HP "POWER INJECTABLE" PORT PHS MEDICAL GMBH DONALD F HULTS
K090155 05/22/2009 CAAS MR FLOW 1.0 PIE MEDICAL IMAGING B.V. SASKIA LLOYD
K090270 05/15/2009 BACKSTOP CATHETER, MODEL 60-0000-3100 PLUROMED, INC. JAMES WILKIE
K082474 05/08/2009 PMT SUBDURAL CORTICAL ELECTRODES PMT CORP. ERIC CAILLE
K090160 05/20/2009 SUPRATHEL WOUND AND BURN DRESSING POLYMEDICS INNOVATIONS GMBH KENNETH K KLEINHENZ
K091215 05/18/2009 INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K091113 05/11/2009 MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
K082817 05/21/2009 PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M PRIMUS STERILIZER COMPANY, LLC. LYLE LOHRMEYER
K090079 05/01/2009 VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 PROGENY, INC. ALAN KREMA
K091097 05/27/2009 PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 PROMEDICAL PRODUCTS CO., LTD. DAVID POWER
K090340 05/22/2009 FREEHAND PROSURGICS LIMITED GEROGE MYERS
K083502 05/05/2009 PANTHER REALART, MODEL 4.7 PROWESS, INC. RACHEL SCARANO
K090457 05/21/2009 ORALUBE PULPDENT CORPORATION KENNETH J BERK
K090391 05/11/2009 PULPDENT MICRO-HYBRID COMPOSITE PULPDENT CORPORATION KENNETH J BERK
K091114 05/01/2009 TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K091175 05/08/2009 GRIND NO MORE VERSION 2 AND 3 RANIR LLC JONATHAN S KAHAN
K090338 05/08/2009 ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE REPROCESSING PRODUCTS CORP. WALLY JANSEN
K090490 05/06/2009 MIRAGE ECHO RESMED CORP. DAVID D'CRUZ
K090243 05/08/2009 REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K091271 05/29/2009 RESPIRONICS PERFORMAX TOTAL FACE MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ANDREW P ZELTWANGER
K091112 05/15/2009 RESPIRONICS SLEEPEASY CPAP SYSTEM RESPIRONICS, INC. ZITA A YURKO
K090321 05/27/2009 RIC CONFORMAL SOURCE, MODEL 100 RI CONSULTANTS, LLC THOMAS GOLEMBESKI
K081138 05/07/2009 SAFEFLO VENA CAVA FILTER RMT MEDICAL TECHNILOGIES INC. JANICE M HOGAN
K090311 05/05/2009 ELECSYS RUBELLA IGG CALCHECK ROCHE DIAGNOSTICS KELLY FRENCH
K090530 05/20/2009 SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 ROSS CREEK MEDICAL INC. MICHAEL KOLBER
K090071 05/28/2009 ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS ROSTAM LTD. ROBERT J STAAB
K090601 05/11/2009 FSC 2 SCHOELLY IMAGING, INC. F. DAVID ROTHKOPF
K090800 05/18/2009 VS-100 ILLUMINATION AND IMAGING SYSTEM SCHOELLY IMAGING, INC. KEN SPECTOR
K090265 05/15/2009 BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V SCICAN LTD. BRENDA MURPHY
K090994 05/06/2009 LIGAFIX INTERFACE SCREW SCIENCE FOR BIOMATERIALS DENIS CLEMENT
K090385 05/06/2009 LARIAT II SUTURE DELIVERY DEVICE SENTREHEART INC. LINDA GUTHRIE
K090520 05/18/2009 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) SHANDONG HUAYUE GLOVE CO., LTD. JINYOU LIN
K090513 05/08/2009 VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) SHANDONG HUAYUE GLOVE CO., LTD. JINYOU LIN
K090691 05/07/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG BENESTAR PLASTIC CO., LTD CHU XIAOAN
K082957 05/29/2009 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
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K090683 05/08/2009 SYNGO RT THERAPIST CONNECT SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
K091373 05/20/2009 SYNGO TRUED SIEMENS MEDICAL SOLUTIONS USA, INC. JAMES E KUHN JR
K091286 05/15/2009 SYNGO US WORKPLACE SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
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K091070 05/19/2009 MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM SIERRA SCIENTIFIC INSTRUMENTS, INC. REIC S FINKELMAN
K090505 05/07/2009 SPEQ ULTRASOUND SYSTEM SIGNOSTICS PTY LTD CHARLES F HOTTINGER
K090420 05/27/2009 SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 SMITH & NEPHEW, INC. SUSAN BELL
K090261 05/01/2009 PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G SMITHS MEDICAL ASD, INC. CINDY ENGELHARDT
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K090858 05/06/2009 PARIETEX MONOFILAMENT POLYESTER MESH SOFRADIM PRODUCTION ANGELA BUNN
K090127 05/01/2009 METATARSAL DECOMPRESSION IMPLANT, MODEL 100 SOLANA SURGICAL LLC BRUCE LAWRENCE
K090684 05/01/2009 AVANTE LEUCITE BLOCKS SOMERSET DENTAL PRODUCTS, INC. CINDY SALTER
K090913 05/04/2009 CROSS-PILOT TURBO ELITE SUPPORT CATHETER SPECTRANETICS CORP. BRANDON HANSEN
K090033 05/06/2009 MODIFICATION TO: PSS SYSTEM SPINAL USA JEFFREY JOHNSON
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K090383 05/29/2009 SRI LEVEL II SURGICAL GOWN SRI SURGICAL NISSA MULNICK
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K081803 05/13/2009 ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM ST. JUDE MEDICAL ANDREA HUDACK
K090567 05/27/2009 ORTHODONTIC CERAMIC BRACKET STAR DENTECH KOREA., CORP BRANDON CHOI
K090371 05/01/2009 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM STERIS CORPORATION JOHN ROBERT SCOVILLE, JR.
K090308 05/01/2009 RESTEP DVY SYSTEM, MODEL RSP-101 STORTFORD MEDICAL LLC CHRIS DAUGHTERY
K091016 05/04/2009 COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN TIM M LOHNES
K090966 05/15/2009 AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) SVRC INDUSTRIES, INC. DEAN EMERSON
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K090831 05/29/2009 TANTHERA-T35 TANTHERA, INC. NATHAN A BEAVER, ESQ
K091417 05/22/2009 SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A TERUMO CORP. MARK UNTERREINER
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K083289 05/06/2009 HUMAN BETA-2 MICROGLOBULIN KIT THE BINDING SITE, LTD. JAY H GELLER
K090282 05/29/2009 QMS LIDOCAINE THERMO FISHER SCIENTIFIC INC. JACK ROGERS
K090856 05/27/2009 JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) THYSSENKRUPP CETECO SRL FEDELE FABRIZIO
K090461 05/22/2009 IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 TOMTEC IMAGING SYSTEMS, GMBH INGE SCHEIDT
K091295 05/15/2009 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K081147 05/29/2009 ISOFLOW INFUSION CATHETER VASCULAR DESIGNS INC. GRACE HOLLAND
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K090066 05/15/2009 POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE WEAR SAFE (MALAYSIA) SDN. BHD. S.H. TAM
K090692 05/08/2009 ORTHOLOC 2.0/2.4 PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. FRED W BOWMAN
K091212 05/27/2009 WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H WU'S TECH CO., LTD. JEN KE-MIN
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K090094 05/20/2009 ZELTIQ SYSTEM ZELTIQ AESTHETICS DONALD V JOHNSON
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