FDA 510(k) Applications Received During September, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K092687 09/01/2009 VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER A PLUS MEDICAL THOMAS LOESCHER
K092740 09/09/2009 ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 ABBOTT LABORATORIES DARLA ABANO
K092704 09/03/2009 ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 ABBOTT MOLECULAR, INC. PAULA MARTIN
K092986 09/28/2009 ACACIA PISTON SYRINGE ACACIA, INC. FERGIE FERGUSON
K093022 09/29/2009 THE PICC WAND PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K092926 09/23/2009 ACELL MATRISTEM WOUND SHEET ACELL, INC RODNEY W BOSLEY
K092755 09/11/2009 STERRAAD 100NX EXPRESS CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS NANCY CHU
K092784 09/10/2009 C. ALBICANS/C. GLABRATA PNA FISH ADVANDX, INC. HENRIK STENDER
K093024 09/29/2009 YEAST TRAFFIC LIGHT PNA FISH ADVANDX, INC. HENRIK STENDER
K092990 09/28/2009 AMD 6605 TENS/NMES ADVANTAGEOUS MEDICAL DEVICES, LLC JOHN HEROD
K092821 09/14/2009 TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 AGENCY FOR MEDICAL INNOVATIONS, INC. ANDREW BENDHEIM
K092824 09/14/2009 N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 ALPHAPROTECH, INC. DAVID KITCHEN
K093077 09/30/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K092538 09/28/2009 REFINE SUPPORT SYSTEM, MODEL 100.0100 ALURE MEDICAL INC. JOSEPH TAMAYO
K092826 09/14/2009 ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL AMERICAN BIOTECH LABS MIRIAM PROVOST
K092735 09/04/2009 GREENLIGHT XPS LASER SYSTEM AMERICAN MEDICAL SYSTEMS, INC. DARLENE-CROCKET BILLIG
K092936 09/24/2009 AMIGO ESCORT 7.5, MODEL 760001 PHS AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K092905 09/21/2009 AUTOSTART BURETTE ANALYTICA PTY LTD ELAINE DUNCAN
K092811 09/14/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 ANDON HEALTH CO.,LTD LIU YI
K092938 09/24/2009 HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 APP PHARMACEUTICALS, LLC ARTHUR WARD
K093075 09/30/2009 ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT ARAGON SURGICAL INC. ALAN CURTIS
K092733 09/04/2009 PYTON ARM MEDICAL DEVICES, INC. ANTHONY CALDERONI
K092943 09/24/2009 ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE ARNOLD TUBER INDUSTRIES MICHAEL TUBER
K093050 09/30/2009 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 ARROW INTL., INC. CHRISTINE FORD
K092807 09/11/2009 HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES ECKLEIN
K092959 09/25/2009 AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 AVITA CORPORATION JENNIFER REICH
K092958 09/25/2009 AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES AVITA CORPORATION JENNIFER REICH
K093008 09/28/2009 HALO ABLATION CATHETER, MODEL 90-9100 BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K092729 09/04/2009 BAXANO NEURO CHECK DEVICE BAXANO, INC. CINDY DOMECUS
K092877 09/18/2009 INDISCAL ASPIRATION DEVICE AND ACCESSORIES BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K092767 09/09/2009 BBL CHROMAGAR MRSA II BECTON DICKINSON & CO. PAUL SWIFT
K093013 09/29/2009 BLOOD PRESSURE MONITOR, MODEL MD200A BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEE FU
K093015 09/29/2009 BINDER INTERVERTEBRAL BODY FUSION DEVICE BINDER BIOMEDICAL, INC LAWRENCE BINDER
K092732 09/04/2009 PROPENCIL ESU PENCIL BIO PROTECH, INC. KEVIN HAN
K092761 09/09/2009 PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C BIO PROTECH, INC. JUDY BURTON
K092791 09/11/2009 KNEEHAB XP CONTROLLER, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K092793 09/11/2009 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K093076 09/30/2009 VITEK 2 GRAM POSITIVE DOXCYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K092973 09/25/2009 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE BIONEN S.A.S. ALLISON SCOTT
K092987 09/28/2009 INRATIO/INRATIO2 TEST STRIPS BIOSITE INCORPORATED KARIN A HUGES
K093032 09/29/2009 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET BIOSITE INCORPORATED MARA CALER
K092786 09/19/2009 INBODY, MODELS: 270, R20, R20B BIOSPACE CORPORATION LIMITED DANIEL KAMM
K093078 09/30/2009 UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K093025 09/29/2009 BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES BOVIE MEDICAL CORPORATION RICHARD KOZLOFF
K092467 09/02/2009 VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED BRAINLAB AG ALEXANDER DRUSE
K092739 09/23/2009 MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE C-LINK MICRO IMAGING, INC MARY P GALLUP
K093068 09/30/2009 FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US C.R. BARD, INC. CINDY MOSS
K093065 09/30/2009 FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 CALIBRA MEDICAL, INC. RICHARD J MEADER
K092949 09/24/2009 IMAGEGRID RADIOLOGY VIEWER SYSTEM CANDELIS, INC. CARL ALETTO
K092684 09/01/2009 LAPAROSCOPIC RETRACTORS CARDINAL HEALTH, INC. SHARON NICHOLS
K092803 09/11/2009 CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT CARDO MEDICAL CORP. DENISE DUCHENE
K092890 09/23/2009 ASTHMA MONITOR AM3 CAREFUSION GERMANY 234 GMBH ELMAR NIDERMEYER
K092782 09/10/2009 INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, CARMEL PHARMA AB. KJELL ANDREASSON
K092915 09/22/2009 CEDARA WEBACCESS, MODEL: 2.4 CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K092917 09/29/2009 STERN'S S250 NORDAM CEFLA S.C. BERTHOIN CLAUDE
K092868 09/18/2009 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CELLAVISION AB CONSTANCE G BUNDY
K092953 09/24/2009 XPERT VANA ASSAY CEPHEID RUSSEL K ENNS
K092641 09/02/2009 CHARMCARE TABLETOP PULSE OXIMETER CHARMCARE CO., LTD JOYCE BANG
K092829 09/15/2009 INSERTEASE CHRISTCOT MEDICAL COMPANY JENNIFER D ENSIGN
K093059 09/30/2009 SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K093051 09/30/2009 HYLATOPIC PLUS EMOLLIENT FOAM COLLEGIUM PHARMACEUTICAL INCORPORATED RONALD M GURGE
K092954 09/25/2009 CADSTREAM VERSION 5 CONFIRMA, INC. BRENT LEWIS
K092898 09/21/2009 CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES CONMED LINVATEC LORNA K LINVILLE
K093052 09/30/2009 CROSSCATH SUPPORT CATHTER COOK, INC. MOLLY BUSENBARK
K092730 09/04/2009 COSMEDENT BRUSHABLE COMPOSITE COSMEDENT, INC. JAMES L SANDRIK
K092847 09/16/2009 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. JEAN SIMON
K092850 09/16/2009 ENDOFLIP CROSPON, LTD. PAUL DRYDEN
K092904 09/21/2009 PATHWAY IVB/VBR CUSTOM SPINE, INC. SAAD ATTIYAH
K092788 09/10/2009 PERIOPHIL BIPHASIC CYTOPHIL INC VICTOR M BOWERS
K092923 09/23/2009 CYTORI PUREGRAFT 250/PURE SYSTEM CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K092944 09/25/2009 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC. HARRY BALA
K092912 09/22/2009 STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 DANVILLE MATERIALS, INC. LINDSAY TILTON
K092864 09/17/2009 AESPIRE 7900, AESPIRE VIEW DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C ADRIENNE LENZ
K093072 09/30/2009 STARCARE HANDPIECE MAINTENANCE UNIT DENTALEZ, INC. KAY ENGLE
K092833 09/15/2009 ENDOMAX CORDLESS ENDODONTIC HANDPIECE DENTAMERICA ERIC HUANG
K092836 09/15/2009 OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K092882 09/18/2009 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K092937 09/24/2009 STA-HYBRID HEP CALIBRATOR DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K093001 09/28/2009 STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INCORPORATED UMBERTO V PARROTTA
K092911 09/22/2009 SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER DIAZYME LABORATORIES ABHIJIT DATTA
K092827 09/14/2009 DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX DIMEDA INSTRUMENTE GMBH ANDREA PECSI
K092928 09/23/2009 DOSE VOLUME HISTOGRAM (DVH) EVALUATOR DIVERSILABS, LLC THOMAS KROENKE
K092873 09/18/2009 REVERSE SHOULDER PROSTHESIS DJO SURGICAL TEFFANY HUTTO
K093010 09/29/2009 MACH LED MC DR. MACH GMBH & CO. KG RAINER ADAMS
K093009 09/29/2009 MACH LED SC DR. MACH GMBH & CO. KG RAINER ADAMS
K092999 09/28/2009 NBP CUFF DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K093057 09/30/2009 BIOMET VISION FOOTRING SYSTEM EBI, L.P. MARGARET F CROWE
K092727 09/04/2009 H100B PULSE OXIMETER EDAN INSTRUMENTS, INC. LI FU
K092997 09/28/2009 ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 EDAN INSTRUMENTS, INC. WILLIAM STERN
K092977 09/25/2009 EBERLE SHAVER SYSTEM ACCESSORIES EFS EBERLE FEINWERKTECHNISCHE SYSTEME GERALD GOIGITZER
K092741 09/08/2009 COLOR LCD MONITOR, MODEL RADIFORCE MX241W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K092844 09/17/2009 GEOSOURCE ELECTRICAL GEODESICS, INC. PAUL HOLMAN
K093019 09/29/2009 ENAMELITE ACRYSEAL SPRAY SEALANT ENAMELITE LLC DAVID C FURR
K093003 09/28/2009 BONASTENT BILIARY ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K092783 09/10/2009 DEBP ENKO LTD. SINAN KAZAZOGLU
K093007 09/28/2009 ENTELLUS MEDICAL BALLOON DEVICE ENTELLUS MEDICAL, INC. SEW-WAH TAY
K092991 09/28/2009 O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) ENVIRONMENTAL TECTONICS CORP. GENE DAVIS
K092913 09/22/2009 EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 EP MEDSYSTEMS SUSHMA RAO
K092849 09/16/2009 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER EPOCAL, INC. ROY LAYER
K092894 09/21/2009 EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Y.C. LEI
K092887 09/21/2009 EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K092734 09/04/2009 E-LIGHT LINE ESPANSIONE MARKETING S.P.A GUIDO BONAPACE
K092860 09/17/2009 LASEMAR 800, 1000, 1500 EUFOTON S.R.L. PAOLO COSSICH
K092736 09/04/2009 EUROIMMUN ANTI-M2-3E ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K092770 09/09/2009 SIMPLYGO HANDS FREE BREAST PUMP EVENFLO COMPANY, INC. AMY NEFF
K092900 09/21/2009 EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM EXACTECH, INC. TARA R PATTERSON
K092831 09/15/2009 DISPOSABLE HYPODERMIC NEEDLE FEEL TECH PETER CHUN
K092846 09/15/2009 AIRVO SERIES HUMIDIFIERS FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K093026 09/29/2009 FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER FOOTPRINT MEDICAL CLYDE BAKER
K093006 09/28/2009 FONIX ,MODEL 8000 FRYE ELECTRONICS, INC. KRISTINA FRYE
K092780 09/10/2009 INF 4160 PLUS, MODEL D-FJ31F FUJI DYNAMICS LIMITED CHING KONG LEE
K093071 09/30/2009 FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 FUNDUS PHOTO, LLC DALE BRODSKY
K092680 09/01/2009 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN GE HEALTHCARE FINLAND OY RAUNO RUOHO
K092756 09/09/2009 GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM GE VINGMED ULTRASOUND AS JAN T THOLLEFSEN
K092992 09/28/2009 A4-XLR8 FOAM DRESSING GENADYNE BIOTECHNOLOGIES, INC. E.J. SMITH
K092970 09/30/2009 GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H GENERAL MEDITECH, INC. LEE FU
K092963 09/25/2009 GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 GENX INTL., INC. MICHAEL D CECCHI
K092851 09/16/2009 MODEL GDCH-2000 GLOBAL DENTAL DIRECT, INC. DON TEMPLE
K093023 09/29/2009 PTFE PEELABLE INTRODUCER GREATBATCH MEDICAL KRISTI FOX
K092682 09/01/2009 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS GYRUS ACMI, INC. LORRAINE CALZETTA
K092772 09/09/2009 PORTABLE X-RAY SYSTEM, MODEL HAND-RAY HANJIN DIGI-X CO., LTD. SHIN KUK YOO
K093044 09/30/2009 OASIS MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K093079 09/30/2009 TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U HOBBS MEDICAL, INC. EMILY MADSEN
K092834 09/15/2009 HOFFMAN XPRESS LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092828 09/14/2009 STATNET, MODEL 3100 HYDRODOT, INC KATHLEEN PRINCIPE
K092892 09/21/2009 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 I-MING SANITARY MATERIALS CO., LTD. SARA HOU
K092842 09/15/2009 ECHOPLAQUE INDEC SYSTEMS, INC. CAROL HUBLER
K093066 09/30/2009 I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 INFIMED, INC. JIGAR SHAH
K092805 09/17/2009 COLLAGEN SPONGE INNOCOLL PHARMACEUTICALS AARON WYSE
K092586 09/30/2009 MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU INNOLATEX (THAILAND) LIMITED GOH SAING
K092715 09/03/2009 IROOT BP PLUS INNOVATIVE BIOCERAMIX INC. QUANZU YANG
K092840 09/15/2009 INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K092883 09/18/2009 LED LAMP OR OTHER INTRAVISTA MEDICAL SYSTEMS INC WEI SU
K092796 09/11/2009 IBA PROTON THERAPY SYSTEM, PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K092966 09/25/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K092806 09/11/2009 AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 K-JUMP HEALTH CO., LTD. JASON CHENG
K093054 09/30/2009 SCALP DURA RETRACTOR, MODEL KS00474 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K092797 09/11/2009 ACUTE AND CHRONIC CATHETER REPAIR KIT KENDALL DANIEL CAMPION
K092867 09/18/2009 IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K092681 09/09/2009 POWDERED LATEX EXAMINATION GLOVES, NON-STERILE KHAI HOAN JOINT STOCK COMPANY PHAM N THANH
K092717 09/03/2009 DIRECT DIGITIZER, REGIUS MODEL 210 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K092870 09/18/2009 NON-STERILE DISPOSABLE VAGINAL SPECULUM KUNSHAN DEYI PLASTIC CO., LTD. CHARLIE MACK
K093043 09/30/2009 ZIRCONIA SYRINGE NEEDLE KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD CHAO-SHENT CHAO
K092965 09/25/2009 TRAILRUNNER GUIDEWIRES LAKE REGION MFG., INC. KAREN MORTENSEN
K092765 09/09/2009 LANX ANTERIOR PLATING SYSTEM LANX, INC. MICHAEL FUNK
K093017 09/29/2009 STELLAR 300 LARSEN & TOUBRO LIMITED E.J. SMITH
K092800 09/11/2009 ANTI-WRINKLE (AGING) LIGHT, MODEL AAL LED INTELLECTUAL PROPERTIES, LLC ROBERT T WAGNER
K092985 09/30/2009 BELLECUP LIBRETTE, INC NEAL KOLBER
K093048 09/30/2009 D-STORM 810NM, D-STORM 980NM LIGHT INSTRUMENTS YORAM LEVY
K092998 09/28/2009 CONMED LINVATEC INTERCEPT IMPLANT LINVATEC CORP. DIONNE SANDERS
K093067 09/30/2009 LIPOSE DISPOSABLE CANNULA LIPOSE CORP. CHRISTINE EMANUEL
K092712 09/03/2009 SKIN BARRIER FILM LODESTAR PRODUCTS, INC. ERIC LUO
K092494 09/14/2009 GEL FILLED GUM SOOTHER LUV N' CARE, LTD. JOSEPH H HAKIM
K092689 09/02/2009 MANUKAPLI WOUND DRESSING MANUKA MEDICAL LIMITED JAMES SMITH
K092903 09/21/2009 "BORA UP 2080", BORA UP 2080 OP" AND "BORA UP 2080 MOUNTING" MAQUET GMBH AND CO. KG ANNETTE JAKOB
K092838 09/15/2009 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 MASIMO CORPORATION MARGUERITE THOMLINSON
K092951 09/24/2009 STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS MECTRON S.P.A. ROGER GRAY
K092737 09/08/2009 EASYRA MG REAGENT, MODEL 10220 MEDICA CORP. PHOTIOS MAKRIS
K092675 09/01/2009 GRINDCARE MEDOTECH A/S CALLEY HERZOG
K092914 09/22/2009 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES MEDSHAPE SOLUTIONS JACK GRIFFIS
K092897 09/21/2009 LAP LOOP MEDSYS, S.A. WILLIAM F GREENROSE
K092676 09/01/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. LILA JOE
K093058 09/30/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. JENNIFER MCBRIDE
K093004 09/28/2009 IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K092859 09/29/2009 MERITS MODEL N SERIES NEBULIZER COMPRESSORS MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K092749 09/08/2009 MAS AND MINI-TROL PTH CONTROL MICROGENICS CORPORATION LISA CHARTER
K093002 09/28/2009 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 MICROVENTION, INC. NAOMI GONG
K092702 09/02/2009 MICRUS MICROCATHETER, MODEL COURIER 270 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K092855 09/16/2009 MILTEX MEMBRANE TACK KIT MILTEX, INC. JENNIFER BOSLEY
K092663 09/01/2009 ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K092746 09/08/2009 MICRONJET 600 NANOPASS TECHNOLOGIES LTD. JONATHAN KAHAN
K092957 09/25/2009 VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC GREGORY SHIPP
K092896 09/21/2009 REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS NEMOTO KYORINDO CO., LTD. JIM KNIPFER
K092908 09/22/2009 NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO NEOMED, INC. PENNY NORTHCUTT
K092699 09/02/2009 NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 NEUROTRONICS, INC. JAMES SCHUBERT
K092742 09/08/2009 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANGFANG
K092964 09/25/2009 COOLTOUCH VARIA ND:YAG LASER SYSTEM NEW STAR LASERS, INC. NATALIE R VOLLRATH
K092930 09/22/2009 NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED NEXUS MEDICAL, LLC HEATHER TURNER
K092801 09/11/2009 ABS BLOWER, ABS NOZZLE, MODEL 1001 NIMBIC SYSTEMS, LLC SEAN SELF
K092899 09/21/2009 OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 NINGBO XINGAOYI MAGNETISM CO., LTD. JIANG MOWEN
K092845 09/15/2009 RESPISENS NOMICS PIERRE ANSAY
K092678 09/01/2009 EVISION DATA MANAGEMENT SOFTWARE NONIN MEDICAL, INC. LORI M ROTH
K092804 09/11/2009 MICROSELECTRON HDR V2, MODEL 105.999 NUCLETRON CORP. ELAINA COLBY
K093069 09/30/2009 NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE NXSTAGE MEDICAL, INC. MICHAEL DOYLE
K092939 09/24/2009 PATLOG 2.0 ONCOLOG MEDICAL QA AB JAN TORNQVIST
K093055 09/30/2009 CSTS SCREW ORTHOPRO LLC J.D. WEBB
K092817 09/14/2009 POC-AS10 AUTO SAMPLER OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K092674 09/01/2009 SIMPLER TOADSTOOL MINI IMPLANT PAN GLOBAL IMPLANT HAROLD BERGMAN
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K092710 09/03/2009 PENTAX ED-3490TK, VIDEO DUODENOSCOPE PENTAX MEDICAL COMPANY LISA LANCIA
K093037 09/29/2009 PENTEX EC-3890LI PENTAX MEDICAL COMPANY LISA LANCIA
K092978 09/28/2009 IMMUNOCAP RAPID READER, MODEL 12-3600-10 PHADIA US INC. MARTIN MANN
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K092910 09/22/2009 FLUID-FILLED TEETHER QUALIMAN INDUSTRIAL CO., LTD KEVIN WALLS
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K092955 09/28/2009 REDSENSE-HOME USE REDSENSE MEDICAL AB CONSTANCE G BUNDY
K092835 09/15/2009 COMFORTGEL NASAL MASK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
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K092719 09/03/2009 DIGITAL BLOOD PRESSURE MONITOR SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD SELINA QIAN
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K092723 09/04/2009 AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM SKELETAL DYNAMICS, LLC JOSEPH M AZARY
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K092969 09/25/2009 H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F STERLING MEDICAL INC THOMAS TRIMNAL
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K093021 09/29/2009 ATLANTIS SLIT LAMP USOPTHALMIC, LLC AL WEISENBORN
K092879 09/18/2009 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER VALLEYLAB PHILIP E AKE
K092871 09/18/2009 TRILOGY MX VARIAN MEDICAL SYSTEMS, INC. VY TRAN
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K092830 09/14/2009 DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH CO., LTD. VINCENT LEE
K092996 09/28/2009 VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 VIOGUARD CRAIG RANTA
K092693 09/02/2009 VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS VIRAMED BIOTECH AG BARRY MENEFEE
K092822 09/14/2009 CAPRI APPLICATOR VIVARAY, INC. GEORGE HERMANN
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K092763 09/09/2009 IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K092857 09/16/2009 VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS WHIP-MIX CORP. STUART STEINBOCK
K092809 09/11/2009 HRV ACQUIRE WR MEDICAL ELECTRONICS CO. GARY SYRING
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