FDA 510(k) Applications Received During July, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K062070 07/21/2006 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR 3M COMPANY DIANNE GIBBS
K062027 07/26/2006 A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K061903 07/05/2006 RELIEVA SINUS BALLOON CATHETER ACCLARENT, INC. KERI YEN
K061975 07/13/2006 PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK ACMI CORPORATION TERRENCE E SULLIVAN
K062084 07/21/2006 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K062145 07/27/2006 MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K062059 07/20/2006 AIE REGION OF INTEREST IMAGE ENHANCEMENT ADVANCED IMAGE ENHANCEMENT JILLIAN M REED
K062135 07/26/2006 ART SHIELDED BREAST APPLICATOR ADVANCED RADIATION THERAPY, LLC RAYMOND J BRICAULT
K061899 07/03/2006 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K062085 07/21/2006 S4 SPINAL SYSTEM AESCULAP KATHY A RACOSKY
K062009 07/17/2006 AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T AESCULAP, INC. MATTHEW M HULL
K062012 07/17/2006 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP, INC. LISA M BOYLE
K062048 07/20/2006 AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM AESTHERA CORPORATION ANNE WORDEN
K061738 07/03/2006 ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K062143 07/27/2006 KOZY COMFORT INFANT POSITIONER ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING ARMAN H NADERSHAHI
K062080 07/21/2006 RESUSCITATION TIMER, MODEL L770-CPR ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K061850 07/31/2006 MINI-YAG LASER AMERICAN LASERS, INC. DAVID K QUON
K061943 07/10/2006 ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM ANATOMICA AB MARCOS VELEZ-DURAN
K062157 07/31/2006 CONFORM APEX DENTAL MATERIALS, INC. CHRIS KULTON
K061981 07/17/2006 SURPASS APEX DENTAL MATERIALS, INC. CHRIS KULTON
K062169 07/31/2006 APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K062100 07/24/2006 ARJOWRAP 47/100 AND 47/88 ARJO WIGGINS MEDICAL, INC. ARTHUR WARD
K061863 07/07/2006 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY ARTHREX, INC. ANN WATERHOUSE
K061925 07/07/2006 MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS ARTHREX, INC. SALLY FOUST
K061954 07/11/2006 ARTELON CMC SPACER ARTHRO ARTIMPLANT AB RUSSELL PAGANO
K061956 07/13/2006 ARTELON STT SPACER ARTIMPLANT AB RUSSELL PAGANO
K061984 07/13/2006 TREASURE ASAHI INTECC CO., LTD. YOSHI TERAI
K062026 07/19/2006 VAP-NT CHOLESTEROL TEST ATHEROTECH, INC. REBECCA K PINE
K062069 07/21/2006 ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K062159 07/31/2006 RB12 SUCTION RECTAL BIOPSY SYSTEM AUS SYSTEMS PTY LTD. IAN P GORDON
K061862 07/06/2006 AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM AXIOM ORTHOPAEDICS, INC. MARY MCNAMARA-CULLINANE
K061926 07/07/2006 CORONIS 2MP AND MDCG 2121 - CB BARCOVIEW LIEVEN DE WANDEL
K061924 07/07/2006 CORONIS 3MP AND MDCG 3120-CB BARCOVIEW LIEVEN DE WANDEL
K061928 07/07/2006 CORONIS COLOR 2MP AND MDCC 2121 BARCOVIEW LIEVEN DE WANDEL
K061927 07/07/2006 CORONIS COLOR 3MP AND MDCC 3120-DL BARCOVIEW LIEVEN DE WANDEL
K062131 07/26/2006 NIO 5MP-M-21" (NIO 5MP MAMMO); MDNG-5121 BB BARCOVIEW LIEVEN DE WANDEL
K062079 07/21/2006 XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION DAVID E CURTIN
K062058 07/20/2006 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 BAYER HEALTHCARE ROGER SONNENBERG
K062087 07/24/2006 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 BD BIOSCIENCES CARTER NAVARRO
K061867 07/03/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K061869 07/03/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML BECTON, DICKINSON & CO. MONICA GIGUERE
K062044 07/19/2006 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K062109 07/24/2006 BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K061949 07/10/2006 DOUBLEPLAY SUTURE ANCHOR BIOCOMPOSITES LTD. SIMON FITZER
K061898 07/06/2006 EZLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K062141 07/27/2006 MAMMOPAD RADIOLUCENT CUSHION BIOLUCENT, INC. SHERYL HIGGINS
K061945 07/10/2006 VITEK 2 AST-YS FLUCONAZOLE BIOMERIEUX, INC. NANCY WEAVER
K062126 07/28/2006 EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 BIOSPHERE MEDICAL, INC. IRINA KULINETS
K061919 07/06/2006 VERSATILE 1 EZCARE WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED JASPER BENKE
K062050 07/20/2006 FLEXVIEW SYSTEM BOSTON SCIENTIFIC CHRISTINA L ROWE
K061877 07/03/2006 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. ELENA BICKOFF
K061884 07/03/2006 BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 BOVIE MEDICAL RICHARD KOZLOFF
K062086 07/21/2006 NAVIVISION BRAINLAB AG RAINER BIRKENBACH
K061912 07/06/2006 FUSION BURKE, INC. DUWAYNE E KRAMER, JR.
K062164 07/28/2006 RESOLUTIONMD, VERSION 1.3 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K061932 07/17/2006 BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE CARDIOPULMONARY CORP. JORDAN SCHRECK
K061960 07/11/2006 FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K062028 07/18/2006 CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 CELERA DIAGNOSTICS VICTORIA MACKINNON
K062016 07/17/2006 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K062015 07/17/2006 CHRONOS VISION EYE TRACKING DEVICE (C-ETD) CHRONOS VISION MAUREEN O'CONNELL
K062120 07/25/2006 CISBIO RENIN RIA TEST CIS BIO INTERNATIONAL GARY LEHNUS
K061876 07/03/2006 CODMAN VPV SYSTEM, MODEL 82-3192 CODMAN & SHURTLEFF, INC. SUSAN KAGAN
K061967 07/19/2006 SCD GARMENT, MODEL VP530 COMPRESSION THERAPY CONCEPTS, INC. LEN NASS
K062046 07/19/2006 MODIFIED MERCI RETRIEVER, MODEL 90050 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K061972 07/27/2006 CONNECT IMAGING PACS CONNECT IMAGING, INC. PHILIP J MANLY
K061937 07/10/2006 COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON COOK ENDOSCOPY MABEL L HUNTER
K061948 07/10/2006 PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS COOPERVISION, INC. LISA HAHN
K062025 07/18/2006 ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 CORGENIX, INC. KIMBERLY N HASSLER
K061855 07/06/2006 NEUROQUANT CORTECHS LABS, INC ALLAN GREEN
K061955 07/11/2006 RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS CREATIVE MEDICAL DESIGNS, INC. JANE RAYHACK
K062140 07/27/2006 SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 CRYOCATH TECHNOLOGIES, INC. FRED MILDER
K061892 07/03/2006 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. JOHN D FERROS
K062152 07/27/2006 CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 DADE BEHRING, INC. VICTOR M CARRIO
K062024 07/18/2006 DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061923 07/07/2006 DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) DADE BEHRING, INC. VICTOR M CARRIO
K061990 07/13/2006 DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062055 07/20/2006 DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062035 07/19/2006 DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K062122 07/25/2006 DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) DADE BEHRING, INC. VICTOR M CARRIO
K062034 07/19/2006 DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) DADE BEHRING, INC. VICTOR M CARRIO
K062121 07/25/2006 DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) DADE BEHRING, INC. VICTOR M CARRIO
K062162 07/28/2006 DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) DADE BEHRING, INC. VICTOR M CARRIO
K062191 07/31/2006 DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 DADE BEHRING, INC. VICTOR M CARRIO
K062182 07/31/2006 DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 DADE BEHRING, INC. VICTOR M CARRIO
K061885 07/03/2006 DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 DADE BEHRING, INC. VICTOR M CARRIO
K062179 07/31/2006 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) DADE BEHRING, INC. SHANNON POPSON
K061872 07/19/2006 MICROSCAN MICROSTREP PLUS PANEL DADE BEHRING, INC. MAUREEN MENDE
K062128 07/26/2006 THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS DADE BEHRING, INC. LORRAINE H PIESTRAK
K062103 07/24/2006 DARCO FORCE TITANIUM COMPRESSION SCREW DARCO INTERNATIONAL, INC. MARK S COOPER
K062098 07/24/2006 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX DATASCOPE CORP. KATHLEEN KRAMER
K062099 07/28/2006 PHASE 3, MODEL DT-1 DATREND SYSTEMS, INC. RON EVANS
K062170 07/31/2006 BIOKNOTLESS AND LUPINE PLUS ANCHORS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K062116 07/25/2006 DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K062148 07/31/2006 DEPUY PINNACLE ALTRX ACETABULAR CUP LINER DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K062174 07/31/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. MARY GRAY
K062007 07/17/2006 DMS 300-7 DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K062088 07/24/2006 PREMIER 11 HOLTER DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K062105 07/25/2006 DIAZYME CREATININE LIQUID REAGENTS ASSAY DIAZYME LABORATORIES ABHIJIT DATTA
K062032 07/18/2006 ACCUSOFT, ACCUSOFT XL DIREX SYSTEMS CORP. LARISA GERSHTEIN
K062147 07/27/2006 INTEGRA SL DIREX SYSTEMS CORP. LARISA GERSHTEIN
K061873 07/03/2006 VERT-X DIREX SYSTEMS CORP. LARISA GERSHTEIN
K061864 07/03/2006 DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 DUKAL CORP. PATRICK J LAMB
K061878 07/06/2006 ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC E SURGICAL, LLC LEWIS WARD
K061996 07/14/2006 SANDMAN POCKET EB NEURO, S.P.A. CARRI GRAHAM
K061978 07/13/2006 EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM EBI, L.P. DEBRA BING
K062134 07/26/2006 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. JASON SMITH
K062054 07/20/2006 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K062053 07/20/2006 MONOCHROME LCD MONITOR, RADIFORCE, GS320 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K061941 07/10/2006 LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 ELEKTA INSTRUMENT AB PETER LOWENDAHL
K062175 07/31/2006 CRYOCARE CN2 SYSTEM ENDOCARE, INC. ALDEN KAY
K062104 07/24/2006 TALKING TRACH ENGINEERED MEDICAL SYSTEMS, INC. PAUL DRYDEN
K061992 07/13/2006 EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 EPS BIO TECHNOLOGY CORP. Y C LEI
K062000 07/17/2006 HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH ETHICON ENDO-SURGERY, INC. CAROL WALSH
K061962 07/12/2006 SURGI-CUF REUSABLE, RS SERIES ETHOX INTERNATIONAL JOHN RIGGI
K061804 07/07/2006 ZERION ALPHA, ; ZERION BETA ETKON INTERNATIONAL GMBH MATTHIAS ZITZMANN
K062045 07/19/2006 EDIA ANTI-CCP EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K062014 07/17/2006 FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB FLAEM NUOVA S.P.A. MAUREEN O'CONNELL
K061930 07/07/2006 INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY FONAR CORP. LUCIANO BONANNI
K062090 07/24/2006 PRISMA SYSTEM R03.10A GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K061918 07/06/2006 FOLEY CATHETERS WITH TEMPERATURE PROBE GE HEALTHCARE JOEL KENT
K061907 07/05/2006 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K061942 07/10/2006 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE HEALTHCARE JOEL C KENT
K061994 07/14/2006 WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE GE HEALTHCARE JOEL KENT
K061953 07/10/2006 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS GE OEC MEDICAL SYSTEMS GREG HANSEN
K062039 07/19/2006 BIOPSY DIGIT-AM GIOTTO USA, LLC ALLISON SCOTT
K062010 07/17/2006 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES GLOBAL TREASURE INDUSTRIES LTD. JANICE MA
K061853 07/18/2006 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES GRACE MEDICAL, INC. JEFF COBB
K061865 07/11/2006 FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 GUIDANT CORP. CHRISTINA L LOWE
K062130 07/28/2006 MEISINGER BENEX, MODEL BE001 HAGER & MEISINGER GMBH ALEX MILLER
K061933 07/07/2006 HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER HAGER WORLDWIDE, INC. JAMES DELANEY
K061991 07/13/2006 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA HELENA LABORATORIES PATRICIA FRANKS
K061879 07/03/2006 SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM HEMODIAGNOSTICA, LLC BRUNO BORGANTI
K061993 07/14/2006 EQUIVITAL, MODEL EQ-01 HIDALGO LIMITED JUSTIN PISANI
K061950 07/10/2006 HHF1 ECHELON MULTI-PURPOSE COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K062107 07/24/2006 SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 HOLOGIC, INC. GAIL YAEKER-DAUNIS
K062180 07/31/2006 ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP HORIBA ABX TIM LAWTON
K062066 07/21/2006 OMEGA 3 SYSTEM HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K062037 07/19/2006 TRIATHLON LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K061521 07/12/2006 TRIATHLON METAL BACKED PATELLA HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K062113 07/24/2006 SOLAR REUNION FRACTURE STEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K061979 07/13/2006 MODIFICATION TO MYALLERGY TEST IMMUNETECH CORPORATION NANCY BENSON
K061969 07/12/2006 PREFORMANCE POSTS AND TEMPORARY CYLINDERS IMPLANT INNOVATIONS, INC. JIM BANIC
K061916 07/06/2006 NEURO II-SE, MODELS OR-MB-DR AND OR-DR IMRIS, INC. THOMAS M TSAKERIS
K061902 07/05/2006 COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 INDITHERM MEDICAL M.W. (ANDY) ANDERSON
K062019 07/17/2006 RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD INNOMED TECHNOLOGIES INC./RESPCARE INC. FRANK PELC
K062151 07/27/2006 BOX PEEK VBR SYSTEM INNOVASIS, INC. WARREN M DANSIE
K061901 07/05/2006 INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS FREDERICK MONTGOMERY
K062129 07/26/2006 P.0004 IMPLANTS INSTITUT STRAUMANN AG ELAINE ALAN
K061974 07/12/2006 GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K061893 07/03/2006 INTEGRA RADIONICS XKNIFE RT 4 INTEGRA RADIONICS, INC. KEVIN O'CONNELL
K062068 07/21/2006 INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 INTELWAVE, LLC ALEXANDER RIFTINE
K062149 07/27/2006 SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES INTERNATIONAL BUSINESS STRATEGIES BILL ROETTGER
K061874 07/06/2006 INVACARE'S TWILIGHT II NASAL MASKS INVACARE CORP. JANICE BROWNLEE
K061889 07/03/2006 BIOSTAR OIA SHIGATOX INVERNESS MEDICAL-BIOSTAR INC. ROBIN C HART
K061952 07/10/2006 CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 INVIVO THOMAS SCHUBERT
K062144 07/27/2006 ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 INVIVO CORPORATION RUSTY KELLY
K061913 07/06/2006 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN REISS
K062074 07/21/2006 IRIDEX WIRELESS FOOTSWITCH IRIDEX CORP. JOHN JOSSY
K061880 07/03/2006 ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC ISOTIS NV ELAINE SCHUTTE
K062033 07/18/2006 BP 101 DIGITAL BLOOD PRESSURE MONITOR KING YIELD HONGKONG LIMITED DACHENG GONG
K061999 07/14/2006 DRY LASER IMAGER, DRYPRO MODEL 832 KONICA MINOLTA MEDICAL & GRAPHIC, INC. JOJI MATSUSHIMA
K062096 07/24/2006 KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST KOREAMEDICO CO. LTD. KIM YOUNG-YONG
K062021 07/17/2006 KOWA VX-10I KOWA CO. LTD. RICHARD PHILLIPS
K061906 07/11/2006 CLEARFIL CERAMIC PRIMER KURARAY MEDICAL INC. KOJI NISHIDA
K061860 07/11/2006 CLEARFIL MAJESTY ESTHETIC KURARAY MEDICAL INC. KOJI NISHIDA
K061491 07/06/2006 LAC-MAC INNERBLOC O.R. GOWN LAC MAC, LTD. JEFFREY O STULL
K061871 07/03/2006 LEICA MODEL FL800 LEICA MICROSYSTEMS, INC. MAX STURGIS
K062003 07/17/2006 NEURO WAVE 6 LHASA OMS, INC. MARK W SHEEHAN
K061966 07/12/2006 LITETOUCH DENTAL LASER SYSTEM LIGHT INSTRUMENT LTD YORAM LEVY
K062052 07/20/2006 LMT NOMAG IC 3.0 LMT LAMMERS MEDICAL TECHNOLOGY GMBH THOMAS M BOHNEN
K061986 07/13/2006 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 MEDCOMP SUSAN MOTZER
K061905 07/05/2006 HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 MEDCON LTD. JONATHAN S KAHAN
K061896 07/03/2006 MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N MEDIAID INC. MAHESH PATEL
K062127 07/25/2006 MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062119 07/26/2006 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 MEDICAL PRODUCTS MFG., LLC ROSINA ROBINSON
K062136 07/26/2006 PASS 2 SPINAL SYSTEM MEDICREA J.D. WEBB
K062181 07/31/2006 C-JAWS CERVICAL COMPRESSIVE MINI FRAME MEDICREA TECHNOLOGIES J.D. WEBB
K061886 07/03/2006 ACTIM PROM AND CONTROLS MEDIX BIOCHEMICA CYNTHIA SINCLAIR
K062041 07/19/2006 MODEL 3875 1 X 8 SC TEST STIMULATION LEAD MEDTRONIC INC. PAULA CORDERO
K061915 07/06/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K062073 07/21/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K061938 07/10/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. LEE GRANT
K062133 07/26/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SPINAL AND BIOLOGICS DIV LEE GRANT
K061958 07/11/2006 MEDTRONIC EXPORT XT CATHETER MEDTRONIC VASCULAR KAREN A BROZOWSKI
K062057 07/20/2006 U-CLIP DEVICE, MODEL NC65 MEDTRONIC VASCULAR DAVID D COX
K061963 07/12/2006 MICRUS MICROCATHETER "COURIER PRE-SHAPED", MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K062036 07/19/2006 MICRUS MICROCOIL SYSTEM "PRESIDIO-18", MODEL PC4 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K061904 07/05/2006 COMPUDENT STA MILESTONE SCIENTIFIC, INC. DANIEL J MANELLI
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