FDA 510(k) Applications Received During April, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K071077 04/17/2007 .DECIMAL APERTURE .DECIMAL, INC. DANIEL BENNETT
K071078 04/17/2007 .DECIMAL RANGE COMPENSATOR .DECIMAL, INC. DANIEL BENNETT
K071131 04/23/2007 UNO 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K070956 04/05/2007 SEA2 SELF ETCH ADHESIVE 3M ESPE DENTAL PRODUCTS KAREN O'MALLEY
K070984 04/06/2007 THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS ABBOTT DIABETES CARE INC. MARIA E TREJO
K071174 04/27/2007 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS ABBOTT SPINE, INC. ZARA OAKES
K070943 04/04/2007 B-SCAN PLUS ACCUTOME ULTRASOUND, INC. Jeffrey Wright
K070929 04/03/2007 ACON U120 URINE ANALYZER, MODEL U111-101 ACON LABORATORIES, INC. MARTIN O'CONNOR
K071014 04/10/2007 MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS YOGI SHAH
K071120 04/20/2007 AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 AEMED, INC. RALPH JUGO
K070981 04/06/2007 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) AESCULAP IMPLANT SYSTEMS, INC. Lisa Boyle
K071125 04/23/2007 AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 AGA MEDICAL CORP. JODI L RAUS
K071162 04/26/2007 AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS AGFA HEALTHCARE CORP. JEFFERY A JEDLICKA
K071165 04/26/2007 ISCALERT SENSOR SYSTEM ALERTIS MEDICAL AS CONSTANCE G BUNDY
K070965 04/05/2007 ALICIA MENSTRUAL CUP ALICIA INTERNATIONAL PTY LTD. TOM STONE
K070924 04/03/2007 FLEXGUARD ALLMED SYSTEMS INC. PETER ALLEN
K071186 04/30/2007 MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE AMBU A/S SANJAY PARIKH
K071185 04/30/2007 MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE AMBU A/S SANJAY PARIKH
K071164 04/26/2007 LIFE+CEL BATTERY AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEX HENDERSON
K070993 04/09/2007 TOPAS SYSTEM AMERICAN MEDICAL SYSTEMS, INC. SARAH PETERSON
K071195 04/30/2007 KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 ANI-KAL II, LLC GERBAIL T KRISHNAMURTHY, MD
K071128 04/23/2007 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES PERRY JOHNSTON
K070990 04/09/2007 APEX MEDICAL MOBINEB, 9R-027 SERIES APEX MEDICAL CORP. ALAN CHANG
K070921 04/02/2007 BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG APPLIED DNA TECHNOLOGIES, INC. Feng-Yu Lee
K071030 04/11/2007 BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC APPLIED DNA TECHNOLOGIES, INC. Feng-Yu Lee
K071111 04/20/2007 NON-ABSORBABLE SILK SUTURE ARROW INTL., INC. KARL J NITTINGER
K071177 04/27/2007 ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW ARTHREX, INC. MARIELA CABARCAS
K071032 04/11/2007 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. NANCY HOFT
K071176 04/27/2007 MODIFICATION TO: ARTHREX INTERFERENCE SCREW ARTHREX, INC. ANN WATERHOUSE, RAC
K070958 04/05/2007 MODIFICATION TO ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070945 04/04/2007 ASAHI PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K071064 04/16/2007 ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K071095 04/18/2007 ASPIRA PLEURAL DRAINAGE SYSTEM BARD ACCESS SYSTEMS, INC. JIHYUN KIM
K071043 04/12/2007 BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB, INC. DEBRA KETCHUM
K071141 04/24/2007 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 BD Biosciences NOBUKO NAKAJIMA
K071143 04/24/2007 BD TRITEST CD3/CD4/CD45, MODEL 340383 BD Biosciences NOBUKO NAKAJIMA
K071026 04/11/2007 BD GENEOHM STAPHSR ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) RAYMOND BOULE
K071002 04/09/2007 IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT BECKMAN COULTER, INC. TARA VIVIANI
K071091 04/18/2007 MODIFICATION TO BILOK SCREW BIOCOMPOSITES LTD. SIMON FITZER
K071115 04/20/2007 MODIFICATION TO BILOK ST SCREW BIOCOMPOSITES LTD. SIMON FITZER
K071121 04/20/2007 TRIBONE 80 BIOMATLANTE ADELINE FILLIATRE
K071146 04/24/2007 VIDAS B.R.A.H.M.S. PCT ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K070961 04/05/2007 BIOMERIX SURGICAL MESH, MODEL: RCR-01 BIOMERIX CORPORATION CHRISTINA L KICHULA
K070955 04/05/2007 ACID ETCHED LAG SCREWS BIOMET ORTHOPEDICS, INC. BECKEY EARL
K071053 04/13/2007 RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD BIOMET, INC. BECKY EARL
K070901 04/02/2007 MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. JESUS T FARINAS
K071004 04/09/2007 OSTEOCRETE BONE VOID FILLER BONE SOLUTIONS, INC. CHRISTINE EMANUEL
K070951 04/04/2007 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS BOSTON SCIENTIFIC BRIAN PARK
K071042 04/12/2007 POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORP. MONICA MORRISON
K071066 04/16/2007 SPYCATCH STONE RETRIEVAL BASKET BOSTON SCIENTIFIC CORP. NEIL KELLY
K071011 04/10/2007 MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K070996 04/09/2007 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K071086 04/17/2007 RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K071108 04/19/2007 TEXIUM SYRINGE CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K070968 04/05/2007 CHOY COMPRESSION FRAME CHOY MEDICAL TECHNOLOGIES, INC. JONATHAN S KAHAN
K071196 04/30/2007 DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS COEUR, INC. DEBRA F MANNING
K070939 04/04/2007 SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM COLOPLAST MANUFACTURING US, LLC REBEKA STOLTMAN
K071100 04/19/2007 AMNISCREEN HOME DETECTION LINER KIT COMMON SENSE, LTD. NATASHA LESKOVSEK
K071172 04/27/2007 MODIFIED MERCI RETRIEVER, MODEL 90060 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K071050 04/13/2007 GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM COOLSYSTEMS, INC. MARIANNE BALDWIN
K071189 04/30/2007 CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER CORDIS EUROPA, N.V. HARM HOVINGA
K070918 04/02/2007 4DDOME COUSIN BIOTECH PAUL DRYDEN
K071148 04/24/2007 ATLAS IMPLANT SYSTEM COWELL MEDI CO., LTD. CHANG D KYU
K071076 04/16/2007 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K071142 04/24/2007 GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA DAN KOSEDNAR
K071158 04/25/2007 AURALAY PIT & FISSURE SEALANT DENALI CORPORATION JAN G STANNARD
K070925 04/03/2007 MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K071135 04/23/2007 DEPUY CI HIP INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K071016 04/10/2007 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DEPUY ORTHOPAEDICS, INC. KATHY HARRIS
K071059 04/16/2007 DEPUY SPA POROUS COATED PROXIMAL SLEEVE DEPUY ORTHOPAEDICS, INC. KATHY HARRIS
K071117 04/20/2007 MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. Natalie Heck
K070994 04/09/2007 EAGLE + ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. FRANK S JURCZAK
K071039 04/12/2007 MISSION OLYMPUS AU ISE CALIBRATORS DIAMOND DIAGNOSTICS, INC. KATHRYN THORSEN
K071168 04/27/2007 THE PORTABLE ANSISCOPE DYANSYS, INC. MICHAEL A DANIEL
K071080 04/17/2007 ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M E SURGICAL, LLC HANS J RICHTER
K071166 04/26/2007 UNIWEB, VERSION 5.0 ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) ANDY YEW
K071103 04/19/2007 HABIB HEXABLATE EMCISION, LTD. NAGY HABIB
K071180 04/30/2007 SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 ENGINEERED MEDICAL SOLUTIONS CO. LLC WILLIAM G MCLAIN
K071028 04/11/2007 VIEWMATE SYSTEM EP MEDSYSTEMS LARRY PICCIANO
K070903 04/02/2007 MYLAB40 ESAOTE EUROPE B.V. CARRI GRAHAM
K070917 04/02/2007 FEEL-JECT INSULIN SYRINGE FEEL TECH DANIEL KAMM
K071104 04/19/2007 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM FLIER'S QUALITY WATER SYSTEMS INC JAMES FLIER
K070920 04/02/2007 FUJI IP CASSETTE TYPE PC FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K071079 04/17/2007 SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 GAMBRO BCT, INC. PATTI L ARNDT
K071020 04/10/2007 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE GE HEALTHCARE JOEL KENT
K071175 04/27/2007 OHMEDA MEDICAL GIRAFFE OMNIBED GE HEALTHCARE AGATA SMIEJA
K071097 04/18/2007 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K071073 04/16/2007 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN M LUNDE
K071153 04/25/2007 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K071187 04/30/2007 MICROFUSE BONE VOID FILLER GLOBUS MEDICAL, INC. KELLY J BAKER
K071022 04/11/2007 POWDER-FREE VINYL EXAMINATION GLOVES GLORMED COLOMBIA S.A. SAM KAO
K070966 04/05/2007 GSO GS1 SPINAL SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K071119 04/20/2007 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) GX CORPORATION SDN BHD FOO KHON PU
K071194 04/30/2007 RAPHAEL COLOR ASV VENTILATOR HAMILTON MEDICAL AG JOERG SCHNEIDER
K071149 04/24/2007 HRI 6500, 6600 AND 6700 SERIES V2MASKS HANS RUDOLPH, INC. KEVIN RUDOLPH
K071018 04/10/2007 MONARCH NASAL IMPLANT HANSON MEDICAL, INC. GERALD HANSON
K071006 04/09/2007 HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K071005 04/09/2007 HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K071007 04/09/2007 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K071150 04/25/2007 TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MAESER
K070963 04/05/2007 REUNION HA FRACTURE STEM HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K071082 04/17/2007 STRYKER MODULAR HIP SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K071092 04/18/2007 ASNIS MICRO CANNULATED SCREW HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K070948 04/04/2007 HSINER NEBULIZER BOTTLE HSINER TOM SHANKS
K070975 04/06/2007 SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES HU-FRIEDY MFG. CO., INC KEITH DUNN
K070979 04/06/2007 PULL TAB SQUEEZE FLUSH ICU MEDICAL, INC TRACY BEST
K071188 04/30/2007 MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K071099 04/19/2007 NEURO II-SE, MODELS: OR-DR-OR, OR-MB IMRIS, INC. THOMAS M TSAKERIS
K070998 04/09/2007 INION BIORESTORE INION OY KATI MARTTINEN
K070904 04/02/2007 ANTLIA II SUCTION PUMP SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K070927 04/03/2007 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K071035 04/12/2007 IFS BONE FIXATION DEVICES INTERNAL FIXATION SYSTEMS, INC. STEVE HERNANDEZ
K071000 04/09/2007 MYRIAN INTRASENSE NICOLAS CLARY
K070947 04/04/2007 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K071118 04/20/2007 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE IVES EEG SOLUTIONS, INC. JOHN R IVES
K071190 04/30/2007 ROOT ZX II J. MORITA USA, INC. ROBERT A SILVERMAN
K071070 04/16/2007 OLYMPUS DENTAL IMPLANT SYSTEM KEYSTONE DENTAL, INC. FLOYD G LARSON
K071067 04/16/2007 BACTRACK LCD ALCOHOL DETECTOR KHN SOLUTIONS, LLC DANIEL KAMM
K071181 04/30/2007 DIRECT DIGITIZER, REGIUS MODEL 110 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K071169 04/27/2007 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KOJI NISHIDA
K071192 04/30/2007 BLUGOO HD LANCER ORTHODONTICS, INC. GRACE HOLLAND
K070995 04/09/2007 ARX-LINK CROSS CONNECTOR LIFE SPINE REBECCA M BROOKS
K070974 04/06/2007 LIGHT RELIEF, MODEL LR150, LR200 LIGHT RELIEF, LLC LAURIE MCLAUGHLIN
K071088 04/18/2007 LIFE LATCH SHARPS & BIOHAZARD CONTAINER M&M INDUSTRIES, INC. NORMAN F ESTRIN
K071047 04/13/2007 MASIMO PATIENT SAFETY NET MASIMO CORPORATION MARGUERITE THOMLINSON
K071024 04/11/2007 MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K071094 04/18/2007 MODIFICATION TO SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K071133 04/23/2007 APEXNRG-BLUE ELECTRONIC APEX LOCATOR MEDICNRG LTD. GEORGE J HATTUB
K071167 04/26/2007 FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 MEDIGROUP, INC. JOHN A NAVIS
K071033 04/12/2007 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K071101 04/19/2007 TRU RSV MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K071019 04/10/2007 DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K070897 04/02/2007 BONEMEDIK, AND BONEMEDIK-S META BIOMED CO., LTD. TAE-HOON KIM
K071137 04/24/2007 SONICATOR PLUS 940, MODEL ME940 METTLER ELECTRONICS CORP. ROB FLEMING
K071085 04/17/2007 E3-80 PORTABLE ECG RECORDER & ANALYZER MICRO-STAR INTERNATIONAL CO., LTD. ALBUM D TSAI
K070934 04/03/2007 PANOSOL II TRU-BLU, MODEL UBL-417 NATIONAL BIOLOGICAL CORP. GEORGE KRINER
K070899 04/02/2007 PURITAN BENNETT LEGENDAIR XL2 NELLCOR PURITAN BENNETT JAMES BONDS
K071154 04/25/2007 SUPERSTAR 0.35T MRI SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD.
K071147 04/24/2007 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM NEXA ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K071058 04/16/2007 MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K071081 04/17/2007 CONTACT LENS CASE NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT Diana Hong
K071145 04/24/2007 NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE NIPRO MEDICAL CORPORATION JESSICA OSWALD
K071182 04/30/2007 PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 NOBEL BIOCARE AB PHUONG NGUYEN SON
K070960 04/05/2007 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K071056 04/16/2007 NEUTROPHASE WOUND CLEANSER NOVABAY PHARMACEUTICALS LUANA STAIGER
K071037 04/12/2007 SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K071191 04/30/2007 NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT NOVARTIS NUTRITION CORP.
K070937 04/04/2007 MULTIPLE BRAND MALE LATEX CONDOM NULATEX SDN. BHD. KIM L LEE
K070983 04/06/2007 OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K070926 04/03/2007 ELECTRODE/EXTENSION CABLES, MODELS ATAR Oscor Inc. MILA DOSKOCIL
K071173 04/27/2007 RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D OSSUR AMERICANS (FORMERLY THE JEROME GROUP) BERNIE TATRO
K071105 04/19/2007 OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM OSTEOMED L.P. DAWN D TINDALL
K070985 04/06/2007 AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC OSYPKA MEDICAL, INC. MARKUS OSYPKA
K071178 04/27/2007 OTOMEDICS SOFT TYMPANOSTOMY TUBE OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. AHAVA STEIN
K071152 04/25/2007 PALOMAR ERBIUM HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE, RAC, CCRA
K071063 04/16/2007 LINASYS PATHFINDER THERAPEUTICS, INC. JAMES D STEFANSIC
K071065 04/16/2007 ORTHADAPT BIOIMPLANT PEGASUS BIOLOGICS, INC. PAMELA MISAJON
K070970 04/06/2007 NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F PENUMBRA, INC. THERESA BRANDNER-ALLEN
K070973 04/06/2007 QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K070928 04/03/2007 CERAMIC BALL HEADS, 28, 32 AND 36 MM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K070950 04/04/2007 LIFT CHAIR, MODEL C5 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K070997 04/09/2007 DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX PRO-MED INSTRUMENTS GMBH EDGAR SCHUELE
K070931 04/03/2007 MODEL PMT850 PROMEDTEK, INC. DIANE MANDELL
K070976 04/06/2007 RII INFRARED EAR THERMOMETER, MODEL TH01BN RADIANT INNOVATION INC. FRANK LIN
K071008 04/09/2007 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL SCOTT A WILSON
K070954 04/05/2007 PATIENTGALLERY IMAGING SOFTWARE RASTER BUILDERS, INC. DAVID L STARK
K071023 04/11/2007 REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C REACH SURGICAL, INC RICH GRANT
K071013 04/10/2007 REDSENSE REDSENSE MEDICAL AB CONSTANCE G BUNDY
K070907 04/02/2007 INTERSON USB ULTRASOUND PROBE SYSTEM REGULATORY MANAGEMENT SERVICES GARY J ALLSEBROOK
K071051 04/13/2007 FRAXEL III SR LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER MACFALLS
K071171 04/27/2007 VPAP AUTO WITH H3I RESMED LTD. DAVID D'CRUZ
K071113 04/20/2007 RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K070999 04/09/2007 BC (BODY COMPOSITION SOFTWARE) RJL SYSTEMS, INC. BARRY CALLAHAN
K071041 04/12/2007 COAGUCHEK XS PLUS SYSTEM Roche Diagnostics THERESA BUSH
K071048 04/13/2007 RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 RUBICOR MEDICAL, INC. ROBERT J CHIN
K071109 04/18/2007 SACS EEG WORKSTATION A7 SACS MEDICAL AB SHEILA RAMERMAN
K071093 04/18/2007 SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 SAN SHIH ELECTRICAL ENTERPRISE CO., LTD. Ke-Min Jen
K070933 04/03/2007 LOWTOP PEDICLE SCREW SYSTEM SANACOR MICHAEL ENSIGN
K070915 04/02/2007 SAPIMED DISPOSABLE SIGMOIDOSCOPE SAPIMED S.P.A. E J SMITH
K070913 04/02/2007 SELF-LIGHT DISPOSABLE ANOSCOPE SAPIMED S.P.A. E J SMITH
K071010 04/09/2007 TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS SCHUTZ-DENTAL GMBH MICHAEL WIERZ
K071155 04/25/2007 MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER SCIENCE FOR BIOMATERIALS DENIS CLEMENT
K070987 04/06/2007 SENTINEL LITHIUM ASSAY SENTINEL CH SPA FABIO ROTA
K070971 04/06/2007 MODIFICATION TO SENTINEL CLIN CHEM CAL SENTINEL CH. SRL FABIO ROTA
K071060 04/16/2007 NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) SGMP CO., LTD. JANNA P TUCKER
K071072 04/16/2007 SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE SHANGHAI CHINA STAR CORP ROMIL RAMBHIA
K070982 04/06/2007 CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K070988 04/06/2007 SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) SHINCHANG MEDICAL CO., LTD. JAN J FRANK
K071074 04/16/2007 MYKRES SPINAL SYSTEM SHOWA IKA KOHGYO CO.,LTD. FLOYD G LARSON
K071114 04/20/2007 SYNGO IMAGING (VERSION V30) SIEMENS AG, MEDICAL SOLUTIONS EVA REITER
K071017 04/10/2007 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS DEBORAH L MORRIS
K071068 04/16/2007 BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 SIEMENS MEDICAL SOLUTIONS USA, INC. CRISTIN WETHERBEE
K071179 04/27/2007 NORAS OR HEAD HOLDER SIEMENS MEDICAL SOLUTIONS USA, INC. JUDITH CAMPBELL
K071015 04/10/2007 OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY RENDON
K071036 04/12/2007 MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI MARTINA VOGT
K071170 04/27/2007 POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL SMART GLOVE CORP. SDN BHD FOO KHON PU
K070908 04/02/2007 SMITH & NEPHEW KINSA RC SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIVISION DEANA BOUSHELL
K071071 04/16/2007 CROSSLINKED POLYETHYLENE ARTICULAR INSERTS SMITH & NEPHEW, INC. RISHI SINHA
K071160 04/26/2007 REFLECTION, TANDEM UNIPOLAR SMITH & NEPHEW, INC. MEGAN BEVILL
K071134 04/23/2007 SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K071061 04/16/2007 ABSORBATACK AND APPLICATOR SORBX, LLC MARY LEE WILLETS
K071156 04/25/2007 SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER SOUNMED, INC. JHOANA LORES
K070905 04/02/2007 ENDOSSEOUS DENTAL IMPLANT SYSTEM SOUTHERN IMPLANTS, INC. GRETA M HOLS
K071161 04/26/2007 ENDOSSEOUS DENTAL IMPLANT SYSTEM SOUTHERN IMPLANTS, INC. GRETA M HOLS
K071151 04/25/2007 TENSION BAND ANTERIOR SPINAL SYSTEM SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC KAREN E WARDEN
K070922 04/02/2007 MODIFICATION TO SPINAL USA VBR SYSTEM SPINAL USA JEFFREY JOHNSON
K070902 04/02/2007 MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 ST. JUDE MEDICAL KAREN J MCKELVEY
K070911 04/02/2007 STD MED PRIMO PORT STD MED, INC. PAMELA PAPINEAU
K071029 04/11/2007 CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) STEREOTAXIS, INC. DENNIS POZZO
K070930 04/03/2007 REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS STERILMED, INC. DENNIS TOUSSAINT
K071087 04/17/2007 VIS-U-ALL II HEAT-SEAL POUCH AND TUBING STERIS Corporation JOHN R SCOVILLE
K071157 04/25/2007 STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS Stryker Endoscopy JEFF SEMONE
K070935 04/03/2007 T.B.R. ZIRCONNECT SUDIMPLANT SA DIDIER SAILHAN
K070896 04/02/2007 ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC. LINDA OLESON
K071184 04/30/2007 SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K071046 04/13/2007 SYNTHES CHRONOS COMPOSITE SYNTHES (USA) JEFFREY DOW
K070946 04/04/2007 SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES SYNTHES (USA) SHERI L MUSGNUNG
K070910 04/02/2007 SYSMEX MODEL UF1000I SYSMEX AMERICA, INC. NINA M GAMPERLING
K070941 04/04/2007 CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 TaiDoc Technology Corporation ERICA LI
K071075 04/16/2007 TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A TERUMO CORP. YOSHIAKI NAGURA
K070900 04/02/2007 FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT THE BINDING SITE, LTD. JAY H GELLER
K070962 04/05/2007 CORAL PEDICLE SCREW SYSTEM THEKEN SPINE LLC DALE DAVISON
K071031 04/11/2007 VU E*POD VERTEBRAL BODY REPLACEMENT THEKEN SPINE LLC DALE DAVISON
K071126 04/23/2007 CRYOSEAL FS APPLICATOR SYSTEM THERMOGENESIS CORP. JOHN CHAPMAN
K071057 04/16/2007 COLONIC & ENEMA NOZZLE TILLER MIND BODY, INC. HAROLD L JONES
K071140 04/24/2007 MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 TOPSPINS, INC. ERIN BUETHE
K071132 04/23/2007 G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 Tosoh BioScience, Inc. CHARLES P GILL
K071027 04/11/2007 TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE TRIBOFILM RESEARCH, INC. VINAY SAKHRANI
K071049 04/13/2007 DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR TYCO HEALTHCARE WEI ZHAO
K071106 04/19/2007 ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 ULTRADENT PRODUCTS, INC. COREY JASEPH
K071055 04/16/2007 OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 ULTRADENT PRODUCTS, INC. ROBERT WANG
K071130 04/23/2007 HEARTRAK AF UNIVERSAL MEDICAL, INC. STEVEN ADAMSKY
K070938 04/04/2007 THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT VASCULAR SOLUTIONS, INC. JAMES CHAPMAN
K071069 04/16/2007 MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY VIASYS SLEEP SYSTEMS, LLC. KEITH BOSECKER
K071193 04/30/2007 VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS VIDAR SYSTEMS CORP. DANIEL KAMM
K071127 04/23/2007 FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K070991 04/09/2007 VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 VITA ELIZABETH WOLFSEN
K071199 04/30/2007 BONALIVE GRANULES VIVOXID LTD. CONSTANCE G BUNDY
K071054 04/16/2007 RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 VOLUME INTERACTIONS PTE LTD MICHAEL SIM
K071183 04/30/2007 ALLEGRO OCULYZER WAVELIGHT AG ALEXANDER POPP
K071163 04/26/2007 WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG ECKHARDT ALBERS
K070964 04/05/2007 KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM WELCH ALLYN, INC. CHRIS HORACEK
K070936 04/03/2007 WELMED HYPODERMIC SYRINGE WELMED INC. DARREN REEVES
K071040 04/12/2007 WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS WRIGHT LINEAR PUMP, INC. CAROL WRIGHT
K071201 04/30/2007 ZEO CE LIGHT & ZEO QUICK PORCELAIN XPDENT CORP. CARMEN PEREZ
K071123 04/23/2007 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K071122 04/23/2007 DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K071090 04/18/2007 TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION ZIMMER TRABECULAR METAL TECHNOLOGY KATHLEEN RUTHERFORD
K071107 04/19/2007 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON ZIMMER, INC. BRANDON HIPSHER
K070906 04/02/2007 MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS ZIMMER, INC. MASON W ROBBINS
K070978 04/06/2007 ZIMMER SEGMENTAL SYSTEM ZIMMER, INC. BRANDON HIPSHER
K071025 04/11/2007 ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE


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