FDA 510(k) Decisions During May, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K053552 05/19/2006 GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA INTL., INC. MICHAEL D CECCHI
K053551 05/09/2006 MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL INTL., INC. MICHAEL D CECCHI
K060295 05/04/2006 CARBON DIOXIDE ABBOTT LABORATORIES LINDA MORRIS
K060383 05/05/2006 GLUCOSE ABBOTT LABORATORIES LINDA MORRIS
K060574 05/03/2006 TOTAL BILIRUBIN ABBOTT LABORATORIES LINDA MORRIS
K060974 05/05/2006 RELIENT NAVIGATION DEVICE ACCLARENT, INC. SU-MIEN CHONG
K061025 05/31/2006 ACCUTECH ENDOLITE PROBE ACCUTECH MEDICAL TECHNOLOGIES, INC. ANNE WORDEN
K060258 05/30/2006 AUTOFUSER ACE MEDICAL US, LLC ANDY LAMBORNE
K060752 05/25/2006 ACMI DUR-HL LASER SYSTEMS ACMI CORPORATION LORRAINE CALZETTA
K060925 05/09/2006 ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 ACON LABORATORIES, INC. EDWARD TUNG
K053035 05/05/2006 ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 ACRO BIOTECH LLC. GREGORY LEE
K060353 05/03/2006 ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 ACRO BIOTECH LLC. GREGORY LEE
K053358 05/25/2006 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES AD-TECH MEDICAL INSTRUMENT CORP. GARY SYRING
K053363 05/30/2006 DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES AD-TECH MEDICAL INSTRUMENT CORP. GARY SYRING
K061029 05/01/2006 JETSTREAM WORKSPACE ADAC LABORATORIES LORI R PETERSON
K060099 05/08/2006 S. AUREUS PNA FISH ADVANDX, INC. AMY AUWLES
K061186 05/12/2006 FLIGHT AERO INNOVATIVE RESEARCH, INC. MATT COCHRAN
K060707 05/31/2006 AESCULAP BIPOLAR ACETABULAR CUP AESCULAP, INC. MATTHEW M HULL
K053579 05/17/2006 COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE AESCULAP, INC. MATTHEW M HULL
K060918 05/26/2006 EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD AESCULAP, INC. KATHY A RACOSKY
K052271 05/26/2006 RINSENDO AIR TECHNIQUES, INC. JOSEPH CAREY
K060388 05/17/2006 TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT AIRWAY MANAGEMENT INC. DARREN HENDERSON
K053257 05/12/2006 PARA-PRO FC50 ALPHA-TEC SYSTEMS, INC. RICHARD WILLIAMS
K053359 05/25/2006 RAPIDTOX AMERICAN BIO MEDICA CORP. FRAN WHITE
K060321 05/15/2006 ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK AMERICAN DIAGNOSTIC CORP. MICHAEL FALCO
K060933 05/09/2006 SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM APEX MEDICAL TECHNOLOGIES, INC. WHITNEY WILLIAMS
K060094 05/08/2006 ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES ARCADIA MEDICAL CORPORATION MARK FOOTE
K052708 05/01/2006 PYLO-PLUS ARJ MEDICAL, INC. PHILIP ROSS
K060478 05/19/2006 ARTHREX BIO-COMPRESSION SCREW ARTHREX, INC. ANN WATERHOUSE
K061259 05/18/2006 MODIFICATION TO ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K060560 05/05/2006 ASCENSION PYROSPHERE CMC/TMT ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K060552 05/24/2006 BC100 BODY COMPOSITION ANALYSIS SYSTEM ATHLETIC IQ, INC. PAMELA PAPINEAU
K060396 05/12/2006 IVENA VASCULAR PATCH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K052392 05/04/2006 HOT DOG PATIENT WARMING SYSTEM AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES D ECKLEIN
K060412 05/17/2006 ACTIVE UNICOMPARTMENTAL KNEE SYSTEM AUSTRALIAN SURGICAL DESIGN & MANUFACTURE JAMES F LOGAN
K060735 05/26/2006 DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM AXIOM WORLDWIDE, INC. JIM GIBSON
K061113 05/23/2006 ORTHOMON AXON SYSTEMS, INC. HOWARD BAILIN
K061326 05/25/2006 VOXAR 3D ENTERPRISE WITH CARDIAMETRIX BARCOVIEW MIS EDINBURGH NEIL PHILLIPS
K053539 05/24/2006 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORPORATION DAVID E CURTIN
K061064 05/17/2006 COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 BECKMAN COULTER, INC. NANCY NADLER
K060324 05/25/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE BECTON DICKINSON & CO. MONICA E GIGUERE
K060558 05/11/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053452 05/25/2006 PURE-AID PREGNANCY TEST BIO FOCUS CO., LT. LAUREN HONG
K060380 05/02/2006 FIDIS DSDNA BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K060692 05/30/2006 COMPREHENSIVE PRIMARY SHOULDER STEMS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K060525 05/25/2006 VANGUARD REMOVABLE MOLDED POLY TIBIA BIOMET MANUFACTURING CORP. TRACY BICKEL JOHNSON
K052639 05/03/2006 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER BIOMET MANUFACTURING, INC. SUSAN ALEXANDER
K060850 05/30/2006 NOD CHEMISTRY CONTROL BIORESOURCE TECHNOLOGY, INC. ERIKA B AMMIRATI
K060701 05/15/2006 BISCEM TRANSLUCENT, BISCEM OPAQUE BISCO, INC. BENJAMIN LICHTENWALNER
K060957 05/05/2006 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELLE VOVOLKA
K060323 05/12/2006 ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 BOSTON SCIENTIFIC CORPORATION JENNIFER KIMBALL
K061199 05/31/2006 ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES BRAUN GMBH AMANDA HEFFERNAN
K060546 05/26/2006 BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 BREAS MEDICAL AB KARL-JOHAN HOLM
K060790 05/25/2006 BREAS, MODEL HA01 BREAS MEDICAL AB KARL-JOHAN HOLM
K061074 05/24/2006 ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW L AUDIE
K061078 05/19/2006 BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW L AUDIE
K061228 05/26/2006 FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR BRYAN KEROPIAN DDS BRYAN KEROPIAN, DDS
K060479 05/12/2006 MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K060561 05/30/2006 CLEARADEX GEL CAMBRIDGEMED PAUL STRATI
K060934 05/15/2006 MODIFICATION TO POWERHEART ECD CARDIAC SCIENCE CORPORATION CHERYL SHEA
K060715 05/15/2006 MODIFICATION TO: CARDIMA ABLATION SYSTEM CARDIMA, INC. ERIC CHAN
K061305 05/25/2006 MEDICAL DISPLAY, MDC1900-1LG (1LR) CHILIN TECHNOLOGY CO. LTD PHIL CHEN
K061303 05/25/2006 MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR CHILIN TECHNOLOGY CO. LTD PHIL CHEN
K052290 05/15/2006 AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS CLEARLAB PTE LTD. MARTIN DALSING
K061182 05/25/2006 CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB CLINIQA CORPORATION CAROL RUGGIERO
K060554 05/02/2006 CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB NANCY BLANCO
K061059 05/25/2006 MODIFIED MERCI RETRIEVER, MODEL 90092 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K061112 05/22/2006 CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M CONMED CORPORATION IRA DUESLER
K061000 05/10/2006 EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 COOK VASCULAR, INC. JIM FERGUSON, JR
K060799 05/02/2006 COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA COSMAN MEDICAL, INC. MICHAEL ARNOLD
K060881 05/16/2006 TEMPORARY CROWN & BRIDGE RESIN COSMEDENT, INC. JAMES L SANDRIK
K061126 05/09/2006 ACCUREX CYBERMED, INC. SONG NAK CHOI
K051442 05/24/2006 PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT CYNOSURE, INC. GEORGE CHO
K060503 05/18/2006 DIMENSION TACR CALIBRATOR, MODEL DC107 DADE BEHRING, INC. YUK-TING LEWIS
K060502 05/18/2006 DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 DADE BEHRING, INC. YUK-TING LEWIS
K053337 05/19/2006 DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 DADE BEHRING, INC. YUK-TING LEWIS
K061020 05/10/2006 DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061238 05/25/2006 DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIESTRAK
K061251 05/31/2006 DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K060369 05/04/2006 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK DADE BEHRING, INC. KATHLEEN DRAY-LYON
K060516 05/15/2006 ELLIPSE 12PL, MODEL 9ESL7228 DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K060860 05/19/2006 TURKOM-CERA DENTAL SUPPLIERS OF AMERICA, INC. DAN WATSON
K060126 05/16/2006 ABSOANCHOR MICROIMPLANT DENTOS INC. ANNA SHAFTO
K061264 05/23/2006 TEMPFX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K060553 05/04/2006 RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K060271 05/04/2006 SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K060581 05/19/2006 DEPUY SOLUTION SYSTEM HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K060746 05/25/2006 MEMORY STAPLE DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K060969 05/12/2006 POLYAX LOCKED PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K053111 05/04/2006 STA-CEPHASCREEN KIT DIAGNOSTICA STAGO, INC. JIM BARROW
K061125 05/23/2006 DVTCARE CA5 DOCTORS ORDERS JERRY KULAS
K060995 05/22/2006 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 DUCKWORTH & KENT, LTD. MARTIN LOCK
K053333 05/02/2006 EAGLEVISION GELLANSERTS, MODEL REF 0040 EAGLE VISION, INC. JEFF COBB
K061098 05/24/2006 EBI OPTILOCK PERIARTICULAR PLATING SYSTEM EBI, L.P. JENNIFER P HARAKAL
K053405 05/11/2006 BACSTOP ELCAM MEDICAL A.C.A.L. TALI HAZAN
K060101 05/10/2006 ESTECH AORTIC EASY FLOW CANNULA ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K061119 05/18/2006 ENPATH MEDICAL STEERABLE SHEATH ENPATH MEDICAL, INC. JAMES JENKINS
K060930 05/04/2006 INSURE II ENTERIX INC. EDWIN DIAZ
K060956 05/04/2006 G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 ESAOTE, S.P.A. CARRI GRAHAM
K060827 05/19/2006 MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 ESAOTE, S.P.A. CARRI GRAHAM
K060928 05/22/2006 CRYOSHAPE ETGAR GROUP H.M.Y.A. LTD. BENNY ARAZY
K061192 05/23/2006 BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER,MST
K060713 05/25/2006 PROCEED SURGICAL MESH ETHICON INC. SERGIO J GADALETA
K050032 05/17/2006 EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS EUROMED, INC. MARY MCNAMARA-CULLINANE
K060786 05/08/2006 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K060784 05/01/2006 SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K052308 05/10/2006 ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM FISHER DIAGNOSTICS M. HEATHER CAMERON
K061063 05/18/2006 MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 FOXHOLLOW TECHNOLOGIES, INC. MELISSA MURPHY
K060926 05/19/2006 TRIPOD FREEDOM DESIGNS, INC. BOB GARDNER
K060964 05/25/2006 ARCHITECT BNP ASSAY, MODEL 8K28 FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K061010 05/23/2006 FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR FUTURE MOBILITY HEALTHCARE INC. WILLIAM SALTER
K060803 05/02/2006 G.USBAMP G.TEC MEDICAL ENGINEERING GMBH CHRISTOPH GUGER
K061370 05/30/2006 CARDIQ FUSION GE HEALTHCARE LARRY A KROGER
K061185 05/15/2006 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE GE HEALTHCARE JOEL KENT
K061372 05/30/2006 CENTRICITY AW SUITE OPTION GE HEALTHCARE INFORMATION TECHNOLOGIES RHODA VALERA
K060993 05/03/2006 GE LOGIQ P5 AND A5 GENERAL ELECTRIC CO. ALLEN SCHUH
K053639 05/08/2006 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K060805 05/24/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K060665 05/10/2006 XPAND RADIOLUCENT CORPECTOMY SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K061104 05/03/2006 SPEECHLINK 100 TYPE 1053 GN OTOMETRICS A/S PER PAPE THOMSEN
K060449 05/30/2006 HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE GUIDANT CORPORATION JENNIFER PAE RIGGS
K061103 05/17/2006 HAEMONETICS 40U RBC FILTER BAG HAEMONETICS CORP. GABRIEL J MURACA
K052371 05/04/2006 DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS HAIR INTERNATIONAL SYSTEMS USA, INC. CRAIG A MITCHELL
K061143 05/10/2006 ROBERTSITE STOPCOCK HALKEY-ROBERTS CORP. RADAMES PIERANTONI
K060352 05/31/2006 HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS HEALTH LINE INTERNATIONAL CORPORATION JACK SPEER
K061014 05/10/2006 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP HELENA LABORATORIES PATRICIA FRANKS
K060994 05/22/2006 MONDIAL HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K053453 05/05/2006 HOMMED CENTRAL STATION, VERSION 3.5 HONEYWELL HOMMED LLC TOMMIE J MORGAN
K060776 05/25/2006 SURGICAL FACE MASK HONG YA NON-WOVEN PRODUCTS CO., LTD. KATHY LIU
K061012 05/19/2006 AXSOS PLUS LOCKING PLATE SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K060977 05/24/2006 MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 HOYA CONBIO, INC JIM GREEN
K053298 05/09/2006 ALPHASPHERE ORBITAL IMPLANT HYDRON PTY LIMITED JUDY F GORDON
K050367 05/24/2006 BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 HYPHEN BIOMED OLA ANDERSON
K060157 05/25/2006 IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K060063 05/19/2006 LEGACY ABUTMENT SYSTEM IMPLANT DIRECT LLC ROSEMARIE MASTELLER
K061177 05/16/2006 PROVIDE TEMPORARY CYLINDER IMPLANT INNOVATIONS, INC. JIM BANIC
K053191 05/12/2006 DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS INNOVA VISION INC. JENNIFER REICH
K060129 05/04/2006 IGS VAGINAL SPECULUM INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC JOSEPH P PAOLO
K061343 05/31/2006 INSPIRSTAR GLOVE ELECTRODE INSPIRSTAR, INC. NING WU
K060931 05/02/2006 HEMOSIL PT-FIBRINOGEN HS PLUS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K053244 05/10/2006 LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT INTEGRA LIFESCIENCES CORP. JON CAPAROTTA
K060539 05/30/2006 DPOAE20 , ECLIPSE INTERACOUSTICS A/S, ASSENS DANIEL EGGAN
K061260 05/18/2006 INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K060905 05/31/2006 IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 IRIDEX CORP. JOHN JOSSY
K060189 05/30/2006 PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) IVES EEG SOLUTIONS, INC. JOHN IVES
K060565 05/08/2006 CONDYLAFORM II NFC IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K060909 05/24/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K060246 05/05/2006 INFREX JOHARI DIGITAL HEALTHCARE LTD. POOJA JOHARI
K060407 05/31/2006 JUNIPER COOLING DEVICE JUNIPER MEDICAL TECHNOLOGY, INC ROSEMARY HARRY
K060240 05/19/2006 K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100 K-JUMP HEALTH CO., LTD. SUSAN D GOLDSTEIN-FALK
K052404 05/23/2006 DENALI DEFORMITY SYSTEM K2M, LLC RICHARD W WOODS
K060442 05/15/2006 PYRENEES CERVICAL PLATE SYSTEM K2M, LLC RICH WOODS
K060822 05/23/2006 VANTAGE INDIRECT OPHTHALMOSCOPE KEELER INSTRUMENTS, INC. EUGENE R VANARSDALE
K061030 05/09/2006 BIOBLANKET SURGICAL MESH KENSEY NASH CORPORATION DEBORAH RACIOPPI
K052824 05/02/2006 KIMBERLY-CLARK PROCEDURE GOWN KIMBERLY-CLARK CORP. CHERYL M SANZARE
K053629 05/31/2006 ANCHOR PLUS/NEO ANCHOR PLUS KJ MEDITECH CHARLIE MACK
K053419 05/11/2006 KONICA MINOLTA PULSOX-300, 300I KONICA MINOLTA SENSING, INC. NANCI DEXTER
K060775 05/16/2006 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM K HWA
K060771 05/01/2006 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM K HWA
K051104 05/31/2006 EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION LAPIS LAZULI, NV MARTIN DALSING
K060247 05/11/2006 LIFE SPINE CEMENT RESTRICTOR LIFE SPINE ERIN MALLOY
K060530 05/22/2006 SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. LIFECORE BIOMEDICAL, INC. RACHEL KENNEDY
K061118 05/19/2006 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. MARY ELLEN HOLDEN
K060198 05/11/2006 MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW LINVATEC CORP. ELIZABETH PAUL
K053637 05/19/2006 MANI NEEDLE & SUTURE PACK (NYLON) MANI, INC. DAVID J BLOCH
K053638 05/19/2006 MANI NEEDLE & SUTURE PACK (SILK) MANI, INC. DAVID J BLOCH
K061072 05/23/2006 ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGIENKS
K060950 05/18/2006 3MATIC MATERIALISE N.V. CARL VAN LIERDE
K060870 05/15/2006 AVANZA MDS NORDION ROSS KACHANIWSKY
K061191 05/22/2006 FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 MEASUREMENT SPECIALTIES, INC. KRISTA OAKES
K053052 05/02/2006 MEDELA SWING BREAST PUMP MEDELA AG WEMER FREI
K060699 05/10/2006 SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) MEDICULT A/S RONALD G LEONARDI
K061213 05/16/2006 SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. SHIM KYUNG-AM
K052674 05/24/2006 CONTACT LENS OPHTHALMODYNAMOMETER MEDITRON, GMBH ROBERT N CLARK
K061128 05/22/2006 MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC. JOHN M KISTE
K060351 05/12/2006 MEDTOX OXYCODONE MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K061274 05/25/2006 VENTURE ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHAME
K061127 05/23/2006 CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R MEDTRONIC VASCULAR PHIL NEURURER
K053230 05/16/2006 MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K053546 05/04/2006 SONICATOR 740, MODEL ME 740 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K061196 05/30/2006 CARDIOIMMUNE XL CARDIAC MARKER CONTROL MICROGENICS CORP. SCOTT HUNTSMAN
K060200 05/31/2006 MICROTEK MEDICAL WARMING DRAPE MICROTEK MEDICAL, INC. THOMAS BONNER
K060116 05/12/2006 MICRUS COURIER MICROCATHETERS MICRUS ENDOVASCULAR CORPORATION MARGARET WEBBER
K051073 05/17/2006 MIDIVIEW SERIES OF MICROENDOSCOPES MILLENNIUM DEVICES, INC. JOSEPH LIBRIZZI
K060816 05/16/2006 MIM 4.0 (NEURO MIMVISTA CORP. PETER SIMMELINK
K060135 05/15/2006 MORTARA SURVEYOR TELEMETRY CENTRAL STATION MORTARA INSTRUMENT, INC. HARLAN VAN MATRE
K060340 05/10/2006 ORAMAGIC PLUS ORAL WOUND RINSE MPM MEDICAL, INC. RICHARD A HAMER
K060122 05/19/2006 SLEEP SPLINT NAKAGAWA DENTAL CLINIC MAKI SAKURABA
K061258 05/18/2006 TRABECTOME HIGH FREQUENCY GENERATOR/LP NEOMEDIX CORP. THOMAS SCHROEDER
K061132 05/24/2006 MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
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