FDA 510(k) Applications Received During March, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K100631 03/05/2010 AFFIITY CP CENTRIFUGAL BLOOD PUMP MEDTRONIC INC. SUE FIDLER
K100646 03/05/2010 AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC. JEFFREY L KOLL
K100645 03/05/2010 AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE MEDTRONIC INC. JESSICA SIXBERRY
K100756 03/17/2010 MALTA 3M ESPE AG DENTAL PRODUCTS DESI SOEGIARTO
K100647 03/08/2010 A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM A-DEC, INC. THOMAS H LOUISELL
K100750 03/16/2010 AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 AALTO SCIENTIFIC LTD. DESSI LYAKOV
K100591 03/02/2010 SORBACT ABIGO MEDICAL AB CONSTANCE BUNDY
K100577 03/01/2010 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE ACCLARENT, INC. KERI YEN
K100823 03/24/2010 WOUND PRO APEX ACCURO MEDICAL PRODUCTS LLC TODD HUBBARD
K100623 03/09/2010 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS LISA M BOYLE
K100802 03/22/2010 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K100876 03/30/2010 AESCULAP MONOMAX ABSORBABLE SUTURE AESCULAP, INC. KATHY A RACOSKY
K100685 03/10/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K100746 03/16/2010 FIBER ONE AMERICAN MEDICAL SYSTEMS DARLENE CROCKETT-BILLIG
K100807 03/22/2010 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 AMERICAN MEDICAL SYSTEMS, INC. DONNA SEMLAK
K100572 03/01/2010 VERSACLOSE, MODEL VC-200-01 ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K100747 03/16/2010 CONTREX PLUS LOW CONTROL SOLUTION APEX BIO TECHNOLOGY CORP THOMAS Y.S. SHEN
K100635 03/05/2010 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 ARROW INTL., INC. TRACY MADDOCK
K100615 03/04/2010 ARSTASIS ACCESS SYSTEM ARSTASIS, INC. SU-MIEN CHONG
K100652 03/08/2010 ACL TIGHTROPE ARTHREX, INC. GEENA AUGUSTINE
K100578 03/12/2010 ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S ASAHI INTECC CO., LTD. YOSHI TERAI
K100743 03/16/2010 ATLAS SPINE PIVOTING SYSTEM ATLAS SPINE INC. JEANNETTE G DAILEY
K100640 03/05/2010 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 B. BRAUN MEDICAL, INC. MATTHEW HOMA
K100607 03/03/2010 COULTER 4C-EX 300 CELL CONTROL BECKMAN COULTER, INC. LOURDES COBA
K100790 03/22/2010 COULTER LIN-X LINEARITY CONTROL, MODEL A81196 BECKMAN COULTER, INC. LOURDES M COBA
K100775 03/18/2010 BD INTIMA II CLOSED IV CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K100722 03/15/2010 TELAVANCIN 30 UG, BBL SENSI-DISC BECTON, DICKINSON AND COMPANY JANINE SPAFFORD
K100740 03/16/2010 MD2000B VITAL SIGN MONITOR, MODEL MD2000B BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANG HONG
K100622 03/04/2010 BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 BELIMED SAUTER AG HANS STADLER
K100700 03/12/2010 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES BENLAN, INC. CHERYL BROWN
K100565 03/01/2010 DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 BIO-DETEK, INC. ROBERT MORSE
K100556 03/03/2010 SLENDERTONE FLEX MAX, MODEL 517 US BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K100589 03/02/2010 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS BIO-RAD FRAN WHITE
K100727 03/15/2010 LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK BIO-RAD, DIAGNOSTICS GRP. SUZANNE PARSONS
K100847 03/25/2010 SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 BIOCOMPATIBLES, INC. WAYNE W RICHARDSON
K100726 03/15/2010 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM BIOLITEC, INC. HARRY HAYES
K100613 03/04/2010 BIOMED WOUND CLEANSER BIOMED LABORATORIES, INC DONALD G WHITE
K100724 03/15/2010 OSSEOTITE II MODEL XIFOSSXXX BIOMET 3I, INC. JOSE E CABRERA
K100805 03/22/2010 GALLERY LAMINOPLASTY FIXATION SYSTEM BIOMET SPINE (AKA EBI, LLC) SHIKHA GOLA
K100691 03/10/2010 OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K100761 03/17/2010 BIOPRO POLAR HEAD BIOPRO, INC. DAVID MRAK
K100560 03/01/2010 EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 BIOTEST MEDICAL CORP. MAGGIE CHU
K100701 03/12/2010 SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 BIOTEST MEDICAL CORP. MAGGIE CHU
K100885 03/30/2010 FETAL MONITOR MODEL: BT-200T BISTOS CO., LTD. YOUNG CHI
K100614 03/04/2010 HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES BLACKSTONE MEDICAL, INC. DARLA CHEW
K100742 03/16/2010 EXACTECH GPS BLUE ORTHO ANTHONY BOYER
K100785 03/23/2010 BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES BONART CO. LTD. ERIC L ONG
K100892 03/31/2010 RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX BOSTON SCIENTIFIC CORP. SCOTT SEPPLE
K100663 03/08/2010 CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 BOSTON SCIENTIFIC CORPORATION DEBBIE MCINTIRE
K100712 03/12/2010 RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE BOSTON SCIENTIFIC CORPORATION ASHLEY PYLE
K100786 03/19/2010 MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX BSD MEDICAL CORP. DIXIE TOOLSON SELLS
K100698 03/11/2010 STCC CARDINAL SPINE, LLC DAVID J COLLETTE
K100714 03/12/2010 CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 CEDARS-SINAI MEDICAL CENTER DAVID R DILLS
K100822 03/23/2010 XPERT MRSA/SA NASAL ASSAY CEPHEID RUSSEL K ENNS
K100723 03/15/2010 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. CHARLIE MACK
K100721 03/15/2010 LOCKING BONE SCREW MODEL HCQ04, HCZ04 CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD. DIANA HONG
K100767 03/18/2010 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM CHURCH & DWIGHT CO., INC. JOSEPH CICCONE
K100695 03/15/2010 COLLADENTAL BARRIER COLLAMATRIX, INC DENNIS J. N. SEAH
K100878 03/30/2010 SELF CATH CATHETER COLOPLAST MANUFACTURING US, LLC BRIAN SCHMIDT
K100703 03/18/2010 STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS COMED CO., LTD BRANDON CHOI
K100686 03/10/2010 CONMED MACROLYTE DISPERSIVE ELECTRODE CONMED CORPORATION SHAWN RIEDEL
K100799 03/22/2010 FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 CONTRACT MEDICAL INTL. GMBH JAN KLOBOUCNIK
K100879 03/30/2010 CONTRALCO CONTRALCO CAMILLE D THORNTON
K100850 03/31/2010 COWELL IMPLANT SYSTEM COWELLMEDI CO., LTD JOYCE BANG
K100841 03/25/2010 BONEOPTIMIZER CURASAN AG CYNTHIA J.M. NOLTE, PH.D.
K100633 03/05/2010 INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 D B ORTHODONTICS LTD ANNA DYSON
K100628 03/09/2010 PLASMALUXLS DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K100891 03/31/2010 DANA EMULATING INDICATOR DANA PRODUCTS, INC. HARRY BALA
K100806 03/22/2010 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM DELBIO INCORPORATION NICKY PAN
K100638 03/05/2010 VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K100838 03/24/2010 ERGO IMAGING SYSTEM DIGIRAD CORP. JOEL TUCKEY
K100765 03/23/2010 FIXPINE II SYSTEM DIO MEDICAL CO., LTD. JOYCE BANG
K100895 03/31/2010 PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) DIPPED PRODUCTS LIMITED W.S.E.F. FERNANDO
K100704 03/12/2010 ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K100794 03/22/2010 FLUORCANASITE DENTAL CERAMIC DR SARAH POLLINGTON JUDY BURTON
K100749 03/16/2010 FREQUENCER MODEL V2X DYMEDSO INC. JEAN BIGONEY
K100595 03/02/2010 ECLERIS MICROSTAR COLPOSCOPE ECLERIS USA RAYMOND J KELLY IV
K100358 03/02/2010 CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS, INC. WILLIAM STERN
K100797 03/22/2010 FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS EDAN INSTRUMENTS, INC. JIGAR SHAH
K100709 03/12/2010 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M EDWARDS LIFESCIENCES, LLC. PATRICIA MILBANK, JD
K100739 03/16/2010 VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 EDWARDS LIFESCIENCES, LLC. PATRICIA MILBANK
K100711 03/12/2010 SUCTION IRRIGATION ELECTRODES AND ADAPTERS ENCISION, INC. JUDITH V KING
K100900 03/31/2010 MOTIVATION KNEE SYSTEM ENCORE MEDICAL, L.P. ELIZABETH ONDERLINDE
K100741 03/17/2010 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K100670 03/09/2010 S-SCAN, MODEL 9800020010 ESAOTE, S.P.A. ALLISON SCOTT
K100883 03/30/2010 CARRIGEN ETEX CORP. CHRISTOPHER KLACZYK
K100597 03/02/2010 HARMONIC FOCUS SHEARS ETHICON ENDO-SURGERY, LLC MARCIA ARENTZ
K100789 03/22/2010 MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST EVALVE INC KARUNA VELUSAMY
K100126 03/10/2010 STELLATE GRIDVIEW EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K100580 03/02/2010 EXSALT WOUND DRESSING EXCITON TECHNOLOGIES INC. JOHN SIMON
K100662 03/08/2010 FEMVUE CORNUAL BALLOON CATHETER FEMASYS INC. LISA PEACOCK
K100753 03/17/2010 FLIGHT 60 VENTILATOR, MODEL F-60 FLIGHT MEDICAL LTD. SHOSHANA FRIEDMAN
K100881 03/30/2010 SYNAPSE OBLIQUUS MIP/MPR/FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K100762 03/17/2010 FLAT PANEL DETECTOR, MODEL FDR D-EVO FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K100831 03/24/2010 CYFRA 21-1 EIA MODEL 211-10 FUJIREBIO DIAGNOSTICS, INC STACEY DOLAN
K100585 03/02/2010 MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 GAYMAR INDUSTRIES, INC. BRIAN L ORWAT
K100757 03/17/2010 TILOCK PEDICLE SCREW SYSTEM GENESYS SPINE JOSH KAUFMANN
K100563 03/01/2010 GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA GEON CORPORATION JENNIFER REICH
K100788 03/22/2010 COCR RODS GLOBUS MEDICAL INC. KELLY BAKER
K100839 03/24/2010 BARIREP GORBEC PHARMACEUTICAL SERVICES, INC. MATTHEW POPP
K100896 03/31/2010 GYRUS ACMI HALO PKS CUTTING FORCEPS GYRUS ACMI, INC. LORRAINE CALZETTA
K100816 03/23/2010 PK SUPERPULSE SYSEM GENERATOR MODEL 744000 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K100731 03/15/2010 BOSWORTH AIR POLISHER HARRY J. BOSWORTH CO. GARY CHUVEN
K100620 03/04/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 HARVARD MEDICAL DEVICES LTD. MARTIN MA
K100745 03/16/2010 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. CINDY GREEN
K100692 03/10/2010 DIGITAL SPOT MAMMOGRAPHY SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K100840 03/24/2010 EMBO PLUS EMBOLECTOMY CATHETER HOTSPUR TECHNOLOGIES ERIC ANKERUD
K100842 03/25/2010 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM HOTSPUR TECHNOLOGIES ERIC ANKERUD
K100884 03/30/2010 STRYKER KNIFELIGHT HOWMEDICA OSTEONICS CORP. AVITAL MERL-MARGULIES
K100734 03/15/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HUANFU PLASTIC PRODUCTS LIMITED CHU XIAOAN
K100702 03/12/2010 STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS HUOT INSTRUMENTS, LLC ANNE WARD
K100576 03/01/2010 HIGH PRESSURE SETS-400 PSI ICU MEDICAL, INC. TRACY BEST
K100811 03/22/2010 IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 IMPEDIMED LIMITED ALDEN KAY
K100660 03/08/2010 INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 INNOCHIPS TECHNOLOGY CO., LTD. BRANDON CHOI
K100574 03/01/2010 COLLEXA INNOCOLL PHARMACEUTICALS AARON WYSE
K100559 03/01/2010 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL INC. JOHN VOZELLA
K100846 03/25/2010 IMC SURGICAL FACE MASK INTERNATIONAL MEDSURG CONNECTION PETER KIM
K100441 03/01/2010 XINIWAVE, MODEL XW-18 INTERNATIONAL TRADE GROUP, INC. BRENT C REIDER
K100624 03/04/2010 INVENDO C20 COLONOSCOPY SYSTEM INVENDO MEDICAL GBMH OLIVER V RUEPPRECHT
K100766 03/29/2010 IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K100590 03/03/2010 EDGE CO2 LASER SYSTEM JM SYSTEM CO., LTD. SU-GUN LEE
K100857 03/26/2010 FUSION MEDICAL RING LOCK SYSTEM JOHN J RICCIO JOHN RICCIO
K100851 03/29/2010 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K100773 03/18/2010 KAI SPOT MODEL KMS 200 KAI MEDICAL, INC. ROBERT NAKATA
K100720 03/17/2010 K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING KAWASUMI LABORATORIES, INC. SUZAN ONEL
K100821 03/23/2010 PREVENA INCISION MANAGEMENT SYSTEM KCI USA, INC. MARGARET MARSH
K100657 03/08/2010 V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM ("V.A.C. ULTA THERAPY SYSTEM") MODEL V.A.C. ULTA THERAPY UNIT MODEL U KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K100803 03/24/2010 OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 KEYMED, INC. RONALD WARREN
K100793 03/22/2010 UROSTATION 3D PROSTATE SUITE KOELIS CECILE DESMULIE
K100706 03/12/2010 VENUS BASIC SPINAL FIXATION SYSTEM L & K BIOMED CO., LTD HEE KYEONG JOO
K100653 03/08/2010 JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD LANG DENTAL MFG. CO., INC. DAVID LANG
K100575 03/01/2010 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM LDR SPINE USA NOAH BARTSCH
K100616 03/04/2010 KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 LIFE TECHNOLOGIES CORPORATION KELLI TANZELLA
K100858 03/26/2010 LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, LIMA-LTO S.P.A. CHERYL HASTINGS
K100593 03/02/2010 SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI "R" SERIES SUTURE PLACEME LSI SOLUTIONS, INC. PETER SPATH
K100610 03/03/2010 LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS LUTRONIC CORPORATION MAUREEN O'CONNELL
K100567 03/17/2010 PEARL DIABETES MANAGEMENT SYSTEM M2 GROUP HOLDINGS, INC. NAGHMEH NOURI
K100617 03/04/2010 MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D MASIMO CORPORATION MARGUERITE THOMLINSON
K100673 03/09/2010 EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 MEDICA CORP. PHOTIOS MAKRIS
K100829 03/24/2010 EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 MEDICA CORP. PHOTIOS MAKRIS
K100874 03/30/2010 LIPOSONIX SYSTEM, MODEL 1 P00XXXX MEDICIS TECHNOLOGIES CORPORATION JONATHAN KAHAN
K100544 03/03/2010 IMPIX LUMBAR INTERBODY DEVICE MEDICREA TECHNOLOGIES JD WEBB
K100798 03/22/2010 MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C MEDRAD, INC. SUSAN LYNN FELIX
K100693 03/11/2010 AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING MEDTRADE PRODUCTS LIMITED JONATHAN D RANFIELD
K100779 03/19/2010 SUSTAIN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MICHELLE OBENAUER
K100677 03/10/2010 LYMPHA PRESS 201MAX, MODEL 201MAX MEGO AFEK AC LTD AHAVA STEIN
K100818 03/23/2010 ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K100569 03/01/2010 MERIT EMBOLECTOMY CATHETER MODEL ASAP100 MERIT MEDICAL SYSTEMS, INC. LINDSAY MARTIN
K100763 03/17/2010 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K100754 03/17/2010 GRAFT DELIVERY SYSTEM MODEL SA-6115 MICROMEDICS, INC. THOMAS A LOPAC
K100596 03/02/2010 CRYOPETTE MID-ATLANTIC DIAGNOSTICS, INC. ELISA D HARVEY
K100683 03/10/2010 NEUROLINK IP MODEL: PK1117 NATUS MEDICAL INCORPORATED GOLDY SINGH
K100625 03/04/2010 REALEYE MODEL VCPS NAVOTEK MEDICAL LTD STEVEN B DATLOF, M.D., J.D.
K100665 03/08/2010 MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX NEEDLETECH PRODUCTS, INC. RICK TRIPP
K100668 03/09/2010 NEMA-ST, MODEL V1.0.2 NERVOMATRIX LTD DAN LAOR
K100744 03/16/2010 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 NEUWAVE MEDICAL, INC DANIEL KOSEDNAR
K100602 03/03/2010 NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K100671 03/09/2010 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K100584 03/02/2010 EVIS EXERAII 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER
K100555 03/01/2010 APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K100819 03/25/2010 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION JOSEPH BISHOP
K100644 03/05/2010 OPTOS LIMITED PANORAMIC 200CAF OPTOS PLC HOWARD M HOLSTEIN
K100861 03/26/2010 R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 OPTOVUE, INC. AZIMUN JAMAL
K100875 03/30/2010 CEROX, MODEL 321OF OR-NIM MEDICAL LTD. MICHAL BALBERG
K100618 03/04/2010 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K100599 03/03/2010 CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K100833 03/24/2010 SYLE SMARTIP OSSPRAY LTD DAVID GREENSPAN
K100815 03/23/2010 OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 OXYPULSE JAMES A DUNNING
K100661 03/08/2010 EARPROBE PATH MEDICAL GMBH KURT RENTEL
K100598 03/03/2010 PENRITH ELETTRA ULTRASOUND SYSTEM PENRITH CORPORATION LAWRENCE ENGLE
K100826 03/24/2010 PENUMBRA CATHERER 025 PENUMBRA, INC. SETH A SCHULMAN
K100769 03/18/2010 PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 PENUMBRA, INC. MICHAELA MAHL
K100862 03/29/2010 BODYFLOW P2CH PHYSIOMED ELEKTROMEDIZIN AG BIRGIT SCHMID
K100708 03/12/2010 PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES PIONEER SURGICAL TECHNOLOGY EMILY M DOWNS
K100854 03/26/2010 PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 PREMIUM PLUS INTERNATIONAL LIMITED DENNIS NG
K100539 03/18/2010 PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE PREVENTIVE TECHNOLOGIES, INC. KENNETH S PETERSON
K100817 03/19/2010 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST PRINCETON BIOMEDITECH CORP. JEMO KANG, PH.D.
K100781 03/19/2010 OBSIDIAN CERAMIC BLOCKS PRISMATIK DENTALCRAFT, INC. KEITH ALLRED
K100801 03/22/2010 PUMA MODEL VERSION 1.0 PROWESS, INC. RACHEL SCARANO
K100813 03/25/2010 QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB PULSE BIOMEDICAL, INC. SALEEM HASAN
K100558 03/01/2010 QUANTA DIODE LASER SYSTEM QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K100678 03/10/2010 SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL PATRICK QUERO
K100777 03/18/2010 ABL837 FLEX ANALYZER RADIOMETER MEDICAL APS ROWENA JANSSON
K100733 03/15/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) RAYEN SAFETY PRODUCTS LIMITED CHU XIAOAN
K100735 03/15/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) RAYU PLASTIC PRODUCTS LIMITED CHU XIAOAN
K100606 03/03/2010 VATEA ENDONTIC IRRIGATION SYSTEM REDENT NOVA LTD JONATHAN S KAHAN
K100641 03/05/2010 INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) RELIEVANT MEDSYSTEMS ADAM SAVAKUS
K100772 03/18/2010 MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) RESMED LTD. DAVID D'CRUZ
K100611 03/03/2010 RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K100603 03/03/2010 RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K100810 03/22/2010 ELECSYS C-PEPTIDE CALCHECK 5 ROCHE DIAGNOSTICS KELLY ADAMS
K100594 03/02/2010 ELECSYS TROPONIN I CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
K100853 03/26/2010 COBAS 8000 MODULAR SERIES ANALYZER ROCHE DIAGNOSTICS CORP. ANGELO PEREIRA
K100604 03/03/2010 OTIS -C PLUS SCIENCES ET BIO MATERIAUX (SBM) DENIS CLEMENT
K093627 03/31/2010 IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. BRANDON CHOI
K100626 03/05/2010 DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 SHENZHEN BIOCARE ELECTRONICS CO., LTD DIANA HONG
K100830 03/24/2010 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD ZHAI PEI
K100699 03/11/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG STAR PLASTIC CO., LTD CHU XIAOAN
K100697 03/11/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD CHU XIAOAN
K100637 03/05/2010 SYNGO.CT CORONARY ANALYSIS SIEMENS AG, MEDICAL SOLUTIONS RALF HOFMANN
K100778 03/19/2010 DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K093626 03/08/2010 INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN A DRAY-LYONS
K100375 03/10/2010 DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 SIEMENS HEALTHCARE DIAGNOSTICS INC. PAMELA JURGA
K100619 03/04/2010 SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 SIEMENS MEDICAL SOLUTIONS USA INC. ELAINE CHANG
K100795 03/22/2010 JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING SMITH & NEPHEW, INC. SHEREEN MYERS
K100897 03/31/2010 LEGION POROUS + HA TIBIAL BASEPLATES SMITH & NEPHEW, INC. MEGAN BEVILL
K100787 03/19/2010 RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT SMITH & NEPHEW, INC. LAURA D REYNOLDS
K100736 03/22/2010 KIRSCHNER AND GUIDE WIRES SMT SCHILLING METALLTECHNIK GMBH ANDRE WEINGERL
K100649 03/08/2010 SOUNDBITE HEARING SYSTEM BY SONITUS SONITUS MEDICAL INC ROBERT J CHIN
K100605 03/03/2010 MIS SYSTEM SPINE WAVE, INC. DENISE DUCHENE
K100710 03/12/2010 ROLL-X GUIDEWIRE ST. JUDE MEDICAL JENNIFER ZWIEFELHOFER
K100707 03/12/2010 REPROCESSED PINS STERILMED, INC. GARRETT AHLBORG
K100852 03/26/2010 STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 STRYKER COMMUNICATIONS ALMA RELJA
K100865 03/29/2010 AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX STRYKER SPINE KIMBERLY S LANE
K100737 03/15/2010 MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM STRYKER SPINE CURTIS TRUESDALE
K100836 03/24/2010 CLEARPOINT SYSTEM SURGIVISION, INC. JOHN J SMITH M.D., J.D.
K100824 03/24/2010 MECHANICAL WHEELCHAIR, MODEL DS 202-S SUZHOU KD MEDICAL JACOB CHANG
K100855 03/26/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K100856 03/26/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K100849 03/26/2010 SYNC-RX SYSTEM, MODEL AS00010 SYNC-RX LTD A ANSELMO
K100776 03/18/2010 SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM SYNTHES (USA) KARL J NITTINGER
K100634 03/05/2010 SYNTHES MATRIX SYSTEM SYNTHES (USA) AMNON TALMOR
K100676 03/10/2010 SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL SYNTHES (USA) KARL J NITTINGER
K100887 03/30/2010 VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY T.A.G. MEDICAL PRODUCTS GEORGE J HATTUB
K100732 03/15/2010 FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 TAIDOC TECHNOLOGY CORPORATION NICKY PAN
K100658 03/08/2010 U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION NICKY PAN
K100694 03/11/2010 COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN TEKMEDIC (M) SDN BHD PATRICK LEONG
K100588 03/02/2010 HUMAN IGA2 KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD JAY GELLER
K100800 03/22/2010 TIDI FACEMASK TIDI PRODUCTS, LLC DION BRANDT
K100889 03/31/2010 ENDOSKELETON TC TITAN SPINE, LLC JOHN J SMITH
K100562 03/01/2010 LATITUDE ELBOW PROSTHESIS TORNIER, INC. BRAHIM HADRI
K100784 03/19/2010 UC-CARE NAVIGO SYTEM UC-CARE LTD. JOHN KAHAN
K100812 03/23/2010 ULTICARE DISPOSABLE PEN NEEDLES ULTIMED, INC. MARY BETH HENDERSON
K100752 03/17/2010 PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) ULTRADENT PRODUCTS, INC. DIANE ROGERS
K100780 03/19/2010 VITAL SUTURES, SUTUREX, CIRUGIA PERUANA UNILENE S.A.C. KEVIN WALLS, RAC
K100669 03/09/2010 CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES US MEDICAL INNOVATIONS LLC KRISTA OAKES
K100890 03/31/2010 VARIAN HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS VY TRAN
K100586 03/10/2010 VENUS FREEZE SYSTEM VENUS CONCEPT LTD YORAM LEVY
K100684 03/10/2010 CELLTRACKS AUTOPREP SYSTEM MODEL:9541 VERIDEX, LLC SARAH MCMANUS
K100687 03/10/2010 VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 VITALOGRAPH(IRELAND) LTD. TOM J HEALY
K100600 03/04/2010 PROSTHODONTIC SCREWDRIVER , MODEL IA-400 W & H DENTALWERK BUERMOOS GMBH JOHANN G SCHARL
K100682 03/10/2010 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U WALLAC OY KAY TAYLOR
K100820 03/23/2010 WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM WENZEL SPINE SOURABH MISHRA
K100656 03/08/2010 COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) WONJIN MULSAN CO., LTD. BRANDON CHOI
K100630 03/05/2010 G-FORCE PEEK SUTURE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K100579 03/02/2010 G-FORCE TI SUTURE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K100886 03/30/2010 INBONE II TOTAL ANKLE REPLACEMENT WRIGHT MEDICAL TECHNOLOGY, INC. KELSEY LEE
K100866 03/29/2010 PROFEMUR HIP SYSTEM MODULAR NECKS WRIGHT MEDICAL TECHNOLOGY, INC. GREGORY NEAL
K100845 03/25/2010 PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES ZIMMER SPINE, INC DAVID PADGETT, RAC (US)
K100654 03/08/2010 ZOLL PROPAQ MD ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS PAUL DIAS
K100705 03/12/2010 ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 ZYNO MEDICAL LLC CHAOYOUNG LEE


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact