FDA 510(k) Applications Received During April, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K061193 04/28/2006 CREATININE ABBOTT LABORATORIES INC LINDA MORRIS
K060902 04/03/2006 STARCLOSE INTRODUCER SET MODEL- 1002 ABBOTT VASCULAR INC. KIM SMITH -SERVANCE
K060974 04/10/2006 RELIENT NAVIGATION DEVICE ACCLARENT, INC. SU-MIEN CHONG
K061025 04/13/2006 ACCUTECH ENDOLITE PROBE ACCUTECH MEDICAL TECHNOLOGIES, INC. ANNE WORDEN
K060925 04/04/2006 ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 ACON LABORATORIES, INC. EDWARD TUNG
K061029 04/14/2006 JETSTREAM WORKSPACE ADAC LABORATORIES LORI R PETERSON
K061058 04/17/2006 NEOZOLINE VENTILATION TUBES ADEPT MEDICAL LTD JASON MARSH
K061186 04/28/2006 FLIGHT AERO INNOVATIVE RESEARCH, INC. MATT COCHRAN
K061135 04/24/2006 MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 AESCULAP LISA WEIKERT
K060918 04/04/2006 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD AESCULAP, INC. KATHY A RACOSKY
K061045 04/14/2006 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K061122 04/24/2006 NIGHT GUARD ALPINE ORAL CARE, LLC CATHY TENG
K061039 04/14/2006 AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K061178 04/27/2006 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K060933 04/05/2006 SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM APEX MEDICAL TECHNOLOGIES, INC. WHITNEY WILLIAMS
K061005 04/11/2006 ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS APPLIED DNA TECHNOLOGIES, INC. Feng-Yu Lee
K061162 04/26/2006 BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 APPLIED SPINE TECHNOLOGIES, INC. MICHELE LUCEY
K060939 04/06/2006 RANGER IRRIGATION FLUID WARMING SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K061071 04/17/2006 V-808 ATOM TRANSCAPSULE ATOM MEDICAL INC MARY STANIEWICZ
K061113 04/21/2006 ORTHOMON AXON SYSTEMS, INC. HOWARD BAILIN
K060970 04/07/2006 AXYALOOP NONABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. Howard Schrayer
K061038 04/14/2006 BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K061157 04/26/2006 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB DEBRA KETCHUM
K061137 04/24/2006 ADVIA IMS CPSA CONTROL BAYER HEALTHCARE, LLC ANDRES HOLLE
K061139 04/24/2006 BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS BAYER HEALTHCARE, LLC ANDRES HOLLE
K061190 04/28/2006 ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 BECKMAN COULTER, INC. VALYNDA L MACHEN
K061064 04/17/2006 COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 BECKMAN COULTER, INC. NANCY NADLER
K060935 04/05/2006 SYNCHRON SYSTEMS CREATININE (CREA) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K061089 04/18/2006 MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 BIOPRO, INC. DAVID MRAK
K061164 04/26/2006 ACTIVAPIN BIORETEC LTD MARI RUOTSALAINEN
K061171 04/27/2006 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX BIOSPHERE MEDICAL, INC. ROSINA ROBINSON
K061166 04/27/2006 DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K060957 04/07/2006 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELLE VOVOLKA
K060942 04/06/2006 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS BOB J. JOHNSON & ASSOCIATES JON HULSEY
K060947 04/06/2006 SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K060960 04/07/2006 BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER Boston Scientific Corporation SARA L COON
K060959 04/07/2006 SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation ANGELA BYLAND
K061199 04/28/2006 ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES BRAUN GMBH AMANDA HEFFERNAN
K061057 04/17/2006 BREAS ISLEEP 20+ BREAS MEDICAL AB KARL-JOHAN HOLM
K061074 04/17/2006 ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW L AUDIE
K061078 04/17/2006 BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW L AUDIE
K060962 04/07/2006 ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K061179 04/27/2006 POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER C.R. BARD, INC. MICHAELA RIVKOWICH
K060906 04/03/2006 CALYPSO 4D LOCALIZATION SYSTEM CALYPSO MEDICAL TECHNOLOGIES INC ERIC MEIER
K060911 04/03/2006 CG-6108 ARRHYTHMIA ECG EVENT RECORDER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K060934 04/05/2006 MODIFICATION TO POWERHEART ECD CARDIAC SCIENCE CORPORATION CHERYL SHEA
K061046 04/14/2006 CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 CARDIOMEMS, INC. CAROL VIERLING
K061075 04/17/2006 BOOMERANG WIRE CARDIVA MEDICAL, INC. GLENN FOY
K061114 04/21/2006 WDS, SIZE 2 AND SIZE 2 CEFLA S.C.R.L. Claude Berthoin
K061062 04/17/2006 XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 CEPHEID RUSSEL K ENNS, PH.D.
K060927 04/04/2006 CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES CERES MEDICAL SYSTEMS, L.L.C. CORRINE BONFIGLIO
K061161 04/26/2006 BLOOD PRESSURE METER, MODEL CH-311B CITIZEN WATCH CO., LTD. JOSEPH D EDMONDSON JR.
K061182 04/27/2006 CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB CLINIQA CORPORATION CAROL RUGGIERO
K061110 04/20/2006 GLUCOMMANDER PLUS COLLABORATIVEMED, LLC ROBERT BOOTH
K060952 04/06/2006 COLLAGEN NERVE WRAP COLLAGEN MATRIX, INC. PEGGY HANSEN
K061173 04/27/2006 CPIVISION DIGITAL IMAGING SYSTEM COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K061059 04/17/2006 MODIFIED MERCI RETRIEVER, MODEL 90092 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K061183 04/28/2006 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 CONFLUENT SURGICAL,INC ERIC P ANKERUD
K061021 04/13/2006 ENTAKE STANDARD AND SAFETY PEG SYSTEM CONMED CORP. BETH A ZIS
K061112 04/21/2006 CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M CONMED CORPORATION IRA DUESLER
K060908 04/03/2006 SONOHYSTEROGRAPHY BIOPSY DEVICE COOK UROLOGICAL, INC. CINDY RUMPLE
K061000 04/11/2006 EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 COOK VASCULAR, INC. JIM FERGUSON, JR
K060966 04/07/2006 COOLTOUCH VARIA ND:YAG LASER SYSTEM COOLTOUCH, INC. DONALD V JOHNSON
K060987 04/10/2006 OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 CP MEDICAL BETSY CORTELLONI
K061126 04/24/2006 ACCUREX CYBERMED, INC. SONG NAK CHOI
K061020 04/13/2006 DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061144 04/25/2006 DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K060969 04/07/2006 POLYAX LOCKED PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K061101 04/20/2006 D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K060929 04/05/2006 IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 DIAGNOSTIC PRODUCTS CORPORATION DEBORAH L MORRIS
K061125 04/24/2006 DVTCARE CA5 DOCTORS ORDERS JERRY KULAS
K060995 04/11/2006 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 DUCKWORTH & KENT, LTD. MARTIN LOCK
K060988 04/10/2006 TOTAL AND HEMI SHOULDER SYSTEM DVO EXTREMITY SOLUTIONS, LLC DINA WEISSMAN
K061016 04/13/2006 EBI ESL PEEK-OPTIMA SPINE SYSTEM EBI, L.P. JENNIFER HARAKAL
K061098 04/19/2006 EBI OPTILOCK PERIARTICULAR PLATING SYSTEM EBI, L.P. JENNIFER P HARAKAL
K061134 04/24/2006 EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES EFS EBERLE FEINWERKTECHNISCHE SYSTEME GERALD GOIGITZER
K061174 04/27/2006 SURGI-MAX ELLMAN INT'L INC. JON GARITO
K060990 04/10/2006 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K060980 04/10/2006 VENDYS MODEL 5000 B/BC ENDOTHELIX, INC. DOUGLAS BLAKELY
K061119 04/21/2006 ENPATH MEDICAL STEERABLE SHEATH ENPATH MEDICAL, INC. JAMES JENKINS
K060930 04/05/2006 INSURE II ENTERIX INC. EDWIN DIAZ
K060956 04/07/2006 G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 ESAOTE, S.P.A. CARRI GRAHAM
K060928 04/04/2006 CRYOSHAPE ETGAR GROUP H.M.Y.A. LTD. BENNY ARAZY
K061156 04/26/2006 ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS ETHICON ENDO-SURGERY, INC. TOM MORRIS
K061192 04/28/2006 BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER,MST
K061050 04/17/2006 GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R ETHICON, INC. BRYAN LISA
K061037 04/14/2006 PDS PLUS ANTIBACTERIAL SUTURE ETHICON, INC. BYRAN A LISA
K060997 04/10/2006 SNAP II EEG MONITOR EVEREST BIOMEDICAL INSTRUMENTS CO. RANDALL J KROHN
K061063 04/17/2006 MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 FOXHOLLOW TECHNOLOGIES, INC. MELISSA MURPHY
K061188 04/28/2006 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM FOXHOLLOW TECHNOLOGIES, INC. MELISSA S MURPHY
K060926 04/04/2006 TRIPOD FREEDOM DESIGNS, INC. BOB GARDNER
K060964 04/07/2006 ARCHITECT BNP ASSAY, MODEL 8K28 FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K061010 04/12/2006 FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR FUTURE MOBILITY HEALTHCARE INC. WILLIAM SALTER
K061185 04/28/2006 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE GE HEALTHCARE JOEL KENT
K061163 04/26/2006 INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K061028 04/13/2006 PRECISION THUNIS 800+ GE MEDICAL SYSTEMS, LLC LARRY KROGER
K061129 04/24/2006 GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 GENERAL ELECTRIC CO. PATRICIA TAIGE
K060993 04/11/2006 GE LOGIQ P5 AND A5 GENERAL ELECTRIC CO. ALLEN SCHUH
K061104 04/20/2006 SPEECHLINK 100 TYPE 1053 GN OTOMETRICS A/S PER PAPE THOMSEN
K061007 04/11/2006 GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS GOOD MEDY ENTERPRISE LTD. JEN KE-MIN
K061115 04/21/2006 SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 GVS SPA DAWN I MOORE
K061153 04/26/2006 GYNESONICS EC6 TRANSDUCER GYNESONICS, INC. JESSICA GROSSMAN, MD
K061103 04/20/2006 HAEMONETICS 40U RBC FILTER BAG HAEMONETICS CORP. GABRIEL J MURACA
K061143 04/25/2006 ROBERTSITE STOPCOCK HALKEY-ROBERTS CORP. RADAMES PIERANTONI
K061090 04/18/2006 GALILEO GOLD ASV HAMILTON MEDICAL AG JOERG SCHNEIDER
K061070 04/17/2006 HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR HANSEN MEDICAL, INC. NINA PELED
K061014 04/13/2006 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP HELENA LABORATORIES PATRICIA FRANKS
K061069 04/17/2006 SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 HELENA LABORATORIES PATRICIA FRANKS
K061047 04/14/2006 HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 HEMOCUE AB ALLAN WHITE
K060994 04/11/2006 MONDIAL HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K061099 04/19/2006 BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 HOFFMAN LABORATORIES, LLC KEITH BOSECKER
K061087 04/18/2006 GENESIS OTC MONITOR HONEYWELL HOMMED, LLC TOMMIE J MORGAN
K061088 04/18/2006 SENTRY OTC MONITOR HONEYWELL HOMMED, LLC TOMMIE J MORGAN
K061138 04/24/2006 ABX PENTRA 400 : CRP HORIBA ABX TIM LAWTON
K061159 04/26/2006 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN HOSPIRA, INC. THOMAS KOZMA
K061168 04/27/2006 PCA 36MM FEMORAL HEADS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K061012 04/12/2006 AXSOS PLUS LOCKING PLATE SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K060921 04/04/2006 S2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K060977 04/10/2006 MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 HOYA CONBIO, INC JIM GREEN
K061006 04/11/2006 IKOENGELO IKOETECH, LLC. HUIMIN CHAO
K061177 04/27/2006 PROVIDE TEMPORARY CYLINDER IMPLANT INNOVATIONS, INC. JIM BANIC
K061032 04/14/2006 DEPOTONE IMPRINT PHARMACEUTICALS LIMITED MERVYN LITTLE
K061147 04/25/2006 OPTERYX ANTERIOR CERVICAL PLATE SYSTEM INNOVASIS, INC. DAVID N MCKEAN
K061176 04/27/2006 STRAUMANN DENTAL IMPLANTS INSTITUT STRAUMANN AG ELAINE ALAN
K060931 04/05/2006 HEMOSIL PT-FIBRINOGEN HS PLUS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K060905 04/03/2006 IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 IRIDEX CORP. JOHN JOSSY
K060910 04/03/2006 POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD CHU XIA OAN
K060909 04/03/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K060914 04/04/2006 TRIDENT ANCHOR JOHNSON & JOHNSON COMPANY Ruth Forstadt
K060907 04/03/2006 KARL STORZ VIDEO GASTROSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K061180 04/27/2006 KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES LEE
K061197 04/28/2006 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER KAWASUMI LABORATORIES, INC. SUZAN ONEL
K060972 04/07/2006 KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) KENDALL KEITH MARTIN
K061030 04/14/2006 BIOBLANKET SURGICAL MESH KENSEY NASH CORPORATION DEBORAH RACIOPPI
K060917 04/04/2006 KENSEY NASH BONE VOID FILLER KENSEY NASH CORPORATION JENNIFER J BOSLEY
K060915 04/04/2006 KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K061017 04/13/2006 EASYSPINE SYSTEM LDR SPINE USA EDWARD E NEWTON
K060920 04/04/2006 VELSCOPE LED MEDICAL DIAGNOSTICS INC. DAVID C MORGAN
K061080 04/18/2006 IR PRO 250 LHASA OMS, INC. MARK W SHEEHAN
K061023 04/13/2006 THERMOSUIT SYSTEM LIFE RECOVERY SYSTEMS HD, LLC PAUL A TENTHOREY
K061055 04/17/2006 CAREO SAFETY SYRINGE FOR U-100 INSULIN LIFE-SHIELD PRODUCTS, INC CHUNG-CHIH HSIAO
K061118 04/21/2006 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. MARY ELLEN HOLDEN
K061072 04/17/2006 ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGIENKS
K060950 04/06/2006 3MATIC MATERIALISE N.V. CARL VAN LIERDE
K061191 04/28/2006 FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 MEASUREMENT SPECIALTIES, INC. KRISTA OAKES
K060983 04/10/2006 BIOPSY MEDIUM, MODEL REF 1062 MEDICULT A/S RONALD G LEONARDI
K061145 04/25/2006 SPERMSLOW MEDICULT A/S RONALD G LEONARDI
K060897 04/03/2006 EMBEDDING TOOL, MODEL TE-1000 MEDIGROUP, INC. JOHN A NEVIS
K061128 04/24/2006 MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC. JOHN M KISTE
K061079 04/17/2006 MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K061127 04/24/2006 CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R MEDTRONIC VASCULAR PHIL NEURURER
K061196 04/28/2006 CARDIOIMMUNE XL CARDIAC MARKER CONTROL MICROGENICS CORP. SCOTT HUNTSMAN
K061092 04/19/2006 BAXTER DUPLOSPRAY MIS APPLICATOR MICROMEDICS, INC. THOMAS LOPAC
K061033 04/14/2006 MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) MILTEX, INC. CHARLES WEAVER
K061116 04/21/2006 MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR MOBILIFE, LLC STEVEN DUFRESNE
K060976 04/10/2006 MOORLD12-B1 LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. DAVID BOGGETT
K061117 04/21/2006 NANOLITE SKIN CARE SYSTEM NANOLITE TECHNOLOGY, INC. EDWIN BURGOS
K061053 04/17/2006 NEUROSTAR TMS SYSTEM NEURONETICS JUDY P WAYS
K061132 04/24/2006 MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K061094 04/19/2006 NEWPORT E500 WAVE VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. RICHARD WATERS
K061086 04/18/2006 DM-3000 DIGITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. LYNETTE HOWARD
K061003 04/11/2006 SFB & CFB IMPLANTS NOBEL BIOCARE AB HERBERT CRANE
K060895 04/03/2006 NOMOSSTAT, VERSION 1.0 NOMOS CORP. LEIGH SPOTTEN
K061169 04/27/2006 ENDOSSEOUS DENTAL IMPLANT NORTHERN IMPLANTS, LLC GRETA M HOLS
K061133 04/24/2006 SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S NOVASPINE LLC HAMID KHOSROWSHAHI
K060971 04/07/2006 OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS OMI MANUFACTURING PTY., LTD. DANIEL KAMM
K061152 04/26/2006 MUCHECK V7.0 ONCOLOGY DATA SYSTEMS, INC. GREG MILLER
K061009 04/12/2006 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS ONSET MEDICAL CORPORATION ALBERT REGO
K060940 04/06/2006 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III Ortho-Clinical Diagnostics, Inc. MARLENE HANNA
K061131 04/24/2006 DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY ORTHOCON, INC. Howard Schrayer
K061124 04/24/2006 ORTHOPEDIC SOURCE PRESS-FIT HIP ORTHOPEDIC SOURCE INC. J D WEBB
K060922 04/04/2006 OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 OXLIFE LLC MARGARET K POTEAT
K061172 04/27/2006 PAJUNK MULTISTIM SENSOR NERVE STIMULATORS PAJUNK GMBH MEDIZINTECHNOLOGIE LYNETTE L HOWARD
K060936 04/05/2006 PARAGOLFER PARABASETEC, GMBH WILLIAM JACKSON
K061123 04/24/2006 PALM ECG RECORDER, MODEL EP-201/202 PARAMA-TECH COMPANY., LTD RICHARD KEEN
K060946 04/06/2006 CZ-S2000 PARKELL, INC. NELSON J GENDUSA
K061102 04/19/2006 PRIMA ANAESTHESIA MACHINE PENLON LTD. BARRY PEARCE
K061068 04/17/2006 EG-3670URK PENTAX MEDICAL COMPANY PAUL SILVA
K061024 04/13/2006 PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 PEREGRINE SURGICAL LTD. TODD RICHMOND
K061052 04/17/2006 THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. HAUKE SCHIK
K060937 04/05/2006 BRILLIANCE VOLUME PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K060941 04/06/2006 CAAS MRV VERSION 3.0 PIE MEDICAL IMAGING B.V. CARL M BEAURLINE
K061151 04/25/2006 PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K061018 04/13/2006 PLANAR DOME EX LINE MODEL DOME E2C PLANAR SYSTEMS, INC. CRAIG HARSHMAN
K061013 04/13/2006 PLAYTEX EMBRACE PETITE BREAST PUMP PLAYTEX PRODUCTS, INC. KARIN E JORDAN
K060981 04/10/2006 PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
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