FDA 510(k) Decisions During March, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K070223 03/13/2007 AUDIT MICROCV LIPIDS LINEARITY SET (LOW) AALTO SCIENTIFIC LTD. ALAN VEKICH
K063449 03/01/2007 DELUXE NEBULIZER ACCESS POINT MEDICAL, L.L.C. JAMES W SANDBERG
K070045 03/26/2007 ZIRBLANK-PS AND ZIRBLANK-FS ACUCERA, INC. KYUNG-BIN LEE
K063863 03/20/2007 ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER ADVANTAGE MEDICAL CABLES, INC. KEN KENDRICKS
K062085 03/02/2007 S4 SPINAL SYSTEM AESCULAP KATHY A RACOSKY
K062327 03/14/2007 MODIFICATION TO S4 SPINAL SYSTEM AESCULAP, INC. LISA M BOYLE
K063155 03/27/2007 MONARCH III IOL DELIVERY SYSTEM ALCON MANUFACTURING, LTD. CATHERINE G GOBLE
K060648 03/19/2007 REPROCESSED PHACOEMULSIFICATION TIPS ALLIANCE MEDICAL CORP. MOIIRA BARTON
K070476 03/26/2007 REVOLIX 120 ALLMED SYSTEMS INC. PETER ALLEN
K063769 03/30/2007 ALPHA BIO BONE FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K063364 03/14/2007 ALPHA BIO DENTAL IMPLANT SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K063770 03/26/2007 ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K061122 03/12/2007 NIGHT GUARD ALPINE ORAL CARE, LLC CATHY TENG
K070342 03/19/2007 CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 AMERICAN I.V. PRODUCTS, INC. JOHN TAYLOR
K070232 03/27/2007 ECG CABLES, TRUNK AND PATIENT LEAD WIRES AMERICAN I.V. PRODUCTS, INC. JOHN TAYLOR
K070065 03/01/2007 AMS SINGLE INCISION SLING SYSTEM (SIS-0) AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K070378 03/09/2007 ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K063674 03/30/2007 EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE ANIMAS CORP. AMY SMITH
K070373 03/02/2007 APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W APOZA ENTERPRISE CO. LTD. JENNIFER REICH
K984205 03/19/2007 SILVERLON ADHESIVE STRIP ARGENTUM INTERNATIONAL LLC. A.BART FLICK
K984204 03/19/2007 SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP ARGENTUM INTERNATIONAL LLC. A.BART FLICK
K984207 03/19/2007 SILVERLON DIRECT PRESSURE WOUND DRESSING ARGENTUM INTERNATIONAL LLC. A. BART FLICK
K070384 03/29/2007 ARGON CONTINUOUS FLUSH DEVICE ARGON MEDICAL DEVICES INC. AMY WINDHAM
K063719 03/06/2007 ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC. ANN WATERHOUSE
K063076 03/29/2007 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER ASCENT HEALTHCARE SOLUTIONS JENN SELVEY
K062026 03/06/2007 VAP-NT CHOLESTEROL TEST ATHEROTECH, INC. Rebecca K Pine
K063734 03/02/2007 ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K063464 03/09/2007 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE INC. JEANNETTE G DAILEY
K070192 03/08/2007 ATRIUM PROLITE ULTRA S MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K063347 03/20/2007 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 AXIS-SHIELD DIAGNOSTICS, LTD. ERICA CONWAY
K070077 03/05/2007 ULTRASOUND SCANNER PROFOCUS, MODEL 2202 B-K MEDICAL APS VILLY BRAENDER
K070509 03/22/2007 FISSO HOLDING SYSTEM BAITELLA AG ANGELIKA SCHERP
K062621 03/19/2007 NIO 5MP-21 AND MDNG-5121 CB BARCOVIEW LIEVEN DE WANDEL
K063694 03/07/2007 AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 BAUSCH & LOMB, INC. NANETTE CANEPA
K062909 03/09/2007 REPEATER PUMP II TUBE SETS BAXA CORP. KIMBERLY ZIZIK
K062711 03/07/2007 ULTRA LOW PROFILE RONGEUR BAXANO, INC. SHARON ROCKWELL
K063689 03/07/2007 BD DIRECTIGEN EZ FLU A+B TEST BECTON DICKINSON & CO. DAINELLE N CLARK
K070440 03/16/2007 BD HYPOINT NEEDLE BECTON DICKINSON & CO. AILEEN C GILBERT
K063486 03/07/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY BECTON, DICKINSON & CO. MONICA E GIGUERE
K070142 03/23/2007 SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 BIO-MEDICAL RESEARCH CORP. ANNE-MARIE KEENAN
K063866 03/19/2007 BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories DAVID BHEND
K070090 03/01/2007 RADIESSE LARYNGEAL IMPLANT BIOFORM MEDICAL, INC. JAMES MILLER
K062994 03/09/2007 LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K070369 03/09/2007 REGENERX RINGLOC + MODULAR ACETABULAR SHELLS BIOMET, INC. ROBERT FRIDDLE
K062840 03/01/2007 TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED FIL V BUENVIAJE
K063874 03/29/2007 DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELE VOVOLKA
K062820 03/15/2007 UNITY ALPHA SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K070402 03/29/2007 MODIFICATION TO POLAR CARE 500 BREG, INC. KATHLEEN BARBER
K063776 03/02/2007 ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW LAW AUDIE
K070073 03/21/2007 ALIGN URETHRAL SUPPORT SYSTEM C.R. BARD, INC. JULIE J BASSETT
K063712 03/12/2007 AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. JOHN C KNORPP
K070508 03/09/2007 BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR C.R. BARD, INC. MICHELLE GUDITH
K070603 03/20/2007 C.T.M. MOBILITTY SCOOTER # HS-295 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K061706 03/05/2007 CADWELL EASYNET OXIMETER MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K063646 03/07/2007 OPTI CAMSIGHT CO., INC. JAY CHOI
K070436 03/16/2007 BIOMARC GOLD TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K070496 03/15/2007 ADVACOAT SINUS GEL AND STENT CARBYLAN BIOSURGERY ROXANNE DUBOIS
K070548 03/29/2007 C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. TIFFINI LALUDE
K070448 03/15/2007 CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 CARDIOMEMS INC GRACE POWERS
K070485 03/22/2007 BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L CARDIVA MEDICAL, INC. MICHAEL J BILLIG
K061062 03/16/2007 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.
DEN070004 03/16/2007 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.
K070394 03/27/2007 CERNER PROVISION WORKSTATION CERNER CORP. SHELLEY S LOOBY
K063353 03/14/2007 CTBOX CERVICAL/LUMBAR TRACTION CIRCULAR TRACTION SUPPLY, INC. DONALD W MEYER
K062120 03/30/2007 CISBIO RENIN RIA TEST CIS BIO INTERNATIONAL Gary Lehnus
K063698 03/02/2007 CO2 LASER SYSTEM, MODEL C-LAS CLINICON CORP. KIM BLOOM
K070269 03/02/2007 MODIFICATION TO COLLAWOUND DRESSING COLLAMATRIX CO., INC. DENNIS J SEAH
K063227 03/14/2007 CONCEIVEX CONCEPTION KIT CONCEIVEX INC. BLIX WINSTON
K063432 03/16/2007 CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) CONFORMIS, INC. MICHAEL SHARP
K063588 03/02/2007 MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 CONMED LINVATEC BIOMATERIALS PAIVI MESIRANTA
K063563 03/07/2007 CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER CORDIS EUROPA, N.V. JOAN MARTIN
K070279 03/14/2007 MODIFICATION TO HYPERTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. ROBERTO F REFECA
K070138 03/27/2007 CUTERA ER:YAG LASER HANDPIECE CUTERA, INC. Connie Hoy
K063867 03/27/2007 CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. Connie Hoy
K070464 03/16/2007 ONDEMAND3D CYBERMED, INC. SONG N CHOI
K063756 03/19/2007 DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K063663 03/21/2007 DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063356 03/23/2007 STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK DADE BEHRING, INC. PAMELA A JURGA
K063466 03/02/2007 TOP FINE DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. DANIEL KAMM
K063348 03/01/2007 TOP FINE INSULIN SYRINGE DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. DANIEL KAMM
K063442 03/26/2007 ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR DEGANIA SILICONE, LTD. ZOYA LEE
K070191 03/07/2007 ALPHA-CORE DC DENTAL TECHNOLOGIES, INC. JANINE RAUHUT
K070306 03/22/2007 PAINT- ON POLISH AGENT DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K070538 03/14/2007 XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE DENTSPLY INTL. HELEN LEWIS
K070359 03/06/2007 DEPUY ASR TAPER SLEEVE ADAPTER DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K063633 03/02/2007 DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES DEPUY ORTHOPAEDICS, INC. STEVEN J WENTWORTH
K062433 03/16/2007 DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM DIAMICS, INC. PETER GOMBRICH
K070542 03/23/2007 CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS DIGIRAD CORP. Joel Tuckey
K063444 03/20/2007 TOTAL ETCH BONDING AGENT DMG USA, INC. PAMELA PAPINEAU
K070123 03/09/2007 TCA 5R / 5S DORNIER MEDTECH AMERICA, INC. Tim Thomas
K070407 03/26/2007 DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE DUKAL CORP. PATRICK J LAMB
K063645 03/15/2007 FREQUENCER, MODEL 1001 DYMEDSO INC. Jean Bigoney
K062873 03/20/2007 SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS E.C.I. USA CORPORATION JAMES WANG
K063293 03/23/2007 EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K062762 03/01/2007 DERMA YAG EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K063512 03/05/2007 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB ANDERS SKOGLUND
K063152 03/07/2007 CLAROS DENTAL LASER SYSTEM ELEXXION AG JOHANNES MUELLER
K062875 03/09/2007 ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. STEVEN J HOFFMAN
K062792 03/01/2007 ERCHONIA IOTO_240 ERCHONIA MEDICAL, INC. KEVIN WALLS,RAC
K070084 03/08/2007 MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL EST. ANTHOGYR ERIC GENEVE
K070479 03/15/2007 EXACTECH NOVATION CROWN CUP AND LINERS EXACTECH, INC. MARITZA ELIAS
K070729 03/30/2007 BALANCEBACK MOBILE INTUITIVE VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC FRANK SCARPINO
K062014 03/22/2007 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
K070177 03/29/2007 FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K063316 03/16/2007 FUJINON MODEL EG-530N TRANS NASAL INSERTION FUJINON, INC. JOSEPH AZARY
K063847 03/01/2007 FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 FUJINON, INC. JOSEPH AZARY
K070482 03/20/2007 ISIS GALIL MEDICAL LTD. JONATHAN S KAHAN
K070190 03/12/2007 GRADIA DIRECT X GC AMERICA INC. TERRY L JORITZ-LYONS
K070698 03/29/2007 COE COMFORT GC AMERICA, INC. TERRY L JORITZ-LYONS
K070697 03/29/2007 COE SOFT GC AMERICA, INC. TERRY L JORITZ-LYONS
K070421 03/13/2007 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 GE HEALTHCARE JOEL KENT
K063324 03/23/2007 PET VCAR GE HEALTHCARE LARRY A KROGER
K062976 03/16/2007 MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K062547 03/21/2007 QUADRA BLOC TENS, MODEL 101 GRADIENT TECHNOLOGIES, LLC JOHN TOWNSEND
K070096 03/14/2007 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR GX CORPORATION SDN BHD FOO KHON PU
K070097 03/23/2007 POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR GX CORPORATION SDN BHD FOO K PU
K070100 03/21/2007 HASELMEIER PEN HASELMEIER SARL MELISSA MAHALL
K070543 03/28/2007 MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. ROBIN BUSH
K070489 03/14/2007 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K070493 03/23/2007 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K070188 03/19/2007 POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW HONG DI PLASTIC PRODUCTS CO, LTD. KATHY LIU
K063445 03/08/2007 PCA CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063552 03/08/2007 SERIES II CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063550 03/08/2007 SYSTEM 12 CONSTRAINED ACETABULAR LINERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K063875 03/15/2007 STRYKER FOOT PLATING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K063384 03/16/2007 DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 HOYA CONBIO, INC LIZA BURNS
K070532 03/20/2007 SPIROS ICU MEDICAL, INC MARTIN MAIER
K050415 03/30/2007 IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS IMPEDIMED PTY LTD. NEVILLE BERTWISTLE
K063403 03/20/2007 CONICAL ANGLED ABUTMENT IMPLANT INNOVATIONS, INC. TAMARA NELSON
K070468 03/23/2007 IMPLANT SCIENCES CORP. MODEL HDR 4454 IMPLANT SCIENCES CORP. MATTHEW HOLLOWS
K063390 03/01/2007 URINE CHEMISTRY ANALYZER UR-50 IND DIAGNOSTIC INC. BRIAN LEMAY
K063673 03/05/2007 INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE INNOVACON, INC. EDWARD TUNG
K070312 03/02/2007 EARCHECK ACOUSTIC REFLECTOMETER INNOVIA MEDICAL, LLC Kevin Walls
K070083 03/12/2007 QUANTA LITE H-TTG/DGP SCREEN INOVA DIAGNOSTICS, INC. BRYS C MYERS
K070635 03/29/2007 HEMOSIL PROCLOT INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K070522 03/15/2007 MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS KAREN MORTIMER
K070011 03/20/2007 IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER IRVINE BIOMEDICAL,INC.(IBI) ROHIT PATEL
K062258 03/21/2007 GENESIS DIODE LASER IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K070114 03/01/2007 CREATION CP-ZI PORCELAIN JENSEN INDUSTRIES, INC. GARY PHELPS
K062480 03/05/2007 JOYKEY SURGICAL DRAPES (STERILE) JOYKEY INDUSTRYIAL LTD. JENNIFER REICH
K062479 03/14/2007 JOYKEY SURGICAL GOWNS (STERILE) JOYKEY INDUSTRYIAL LTD. JENNIFER REICH
K070127 03/29/2007 PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 KEVIN VU, DDS Glen Feye
K062033 03/23/2007 BP 101 DIGITAL BLOOD PRESSURE MONITOR KING YIELD HONGKONG LIMITED DACHENG GONG
K062659 03/09/2007 KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K070169 03/26/2007 KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE KLS MARTIN L.P. JENNIFER DAMATO
K070325 03/21/2007 CLEARFIL MAJESTY ESTHETIC PLT KURARAY MEDICAL INC. KOJI NISHIDA
K063001 03/07/2007 SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES LASERING S.R.L. ALLEN R HOWES
K070433 03/16/2007 LERADO, POWER WHEELCHAIR, PB LERADO CHINA LIMITED JEN KE-MIN
K062308 03/20/2007 LMT-KATH-S; LMT-KATH-I LICHER MEDIZINTECHNOLOGIE GMBH DIETER MUSHOFF
K070285 03/13/2007 LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE REBECCA M BROOKS
K070344 03/08/2007 LIV BREAST SELF EXAMINATION AID LIV INTERNATIONAL USA, INC. PARTICK GORA
K061504 03/19/2007 POWDER FREE NITRILE BLUE EXAMINATION GLOVE LIWE TRADING K M LEE
K063452 03/29/2007 MA 55 MAESTRO MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC) DANIEL EGGAN
K070442 03/16/2007 POWERLED SURGICAL LIGHT SYSTEM MAQUET S.A. KEVIN M TOMPKINS
K070048 03/15/2007 GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT MARIAN MEDICAL, INC. SANDRA WINKLER
K063795 03/05/2007 GUARDIANCATHETER-URINARY DRAINAGE CATHETER MARIAN MEDICAL, INC. SANDRA WINKLER
K063648 03/07/2007 SURGI-WRAP MAST TENDON SHEET MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K070176 03/01/2007 MAXHEALTH MECHANICAL WHEELCHAIR, K1 MAXHEALTH CORP. JEN KE-MIN
K063864 03/26/2007 QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS MEDICAL ELECTRONIC SYSTEMS LTD. Erika B Ammirati
K061489 03/16/2007 ATRILAZE MI SURGICAL ABLATION SYSTEM MEDICALCV, INC. DENNY STEGER
K063504 03/09/2007 ECONOLITH EM1000 MEDISPEC, LTD. ANIL DHINGRA
K063090 03/27/2007 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY MEDRAD, INC. TROY A JACK
K063401 03/26/2007 BANANA RIBBED MEDTECH PRODUCTS LTD. RAVI REDDY
K070072 03/15/2007 NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG (MDM)
K063210 03/15/2007 ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT MICHELLE NIVALA
K063248 03/13/2007 ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K063491 03/05/2007 T2 SCEPTOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SEIFERT
K070173 03/14/2007 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRISTINE SCIFERT
K070039 03/21/2007 MEMOMETAL FIXOS SCREWS MEMOMETAL TECHNOLOGIES GILLES AUDIC
K070031 03/19/2007 MEMOMETAL MEMORY STAPLES MEMOMETAL TECHNOLOGIES GILLES AUDIC
K070033 03/19/2007 MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 MEMOMETAL TECHNOLOGIES GILLES AUDIC
K063043 03/21/2007 SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP MODERN HEALTHCARE CORP. JEN KE-MIN
K063044 03/23/2007 CARDIOBELT ELECTRODE BELT MONEBO TECHNOLOGIES, INC. DALE J MISCZYNSKI
K062282 03/22/2007 MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 MONEBO TECHNOLOGIES, INC. DALE J MISCZYNSKI
K060976 03/27/2007 MOORLD12-B1 LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. DAVID BOGGETT
K070539 03/15/2007 MORTARA ELI 10 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. LAURA M SPIEGELHOFF
K063676 03/05/2007 DBX DEMINERALIZED BONE MATRIX MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ
K063321 03/30/2007 D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 NEKS TECHNOLOGIES, INC. NAIM KARAZIVAN
K060452 03/13/2007 ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH NEO-GENESIS JANNET BALDWIN
K070447 03/29/2007 NEWDEAL COMPRESSION PLATE NEWDEAL SAS JUDITH E O'GRADY
K061971 03/06/2007 ZIRCONIA IMPLANT NOBEL BIOCARE AB HERBERT CRANE
K063804 03/23/2007 OLYMPUS TRIGLYCERIDE TEST SYSTEM OLYMPUS AMERICA, INC. BEV HARDING
K063786 03/05/2007 ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K070477 03/09/2007 ORISON EMBRACE SYSTEM ORISON CORPORATION JOHN DIXON
K063792 03/02/2007 OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM OSTEOMED L.P. PIEDAD PENA
K063298 03/02/2007 OSTEOMED HEADLESS CANNULATED SCREW SYSTEM OSTEOMED L.P. DAWN D TINDALL
K070262 03/14/2007 ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K070350 03/14/2007 P&F POWER WHEELCHAIR, HC-510 P&F BROTHER IND.,CORP Ke-Min Jen
K070179 03/07/2007 TROKABONE, TROKABONE STERNAL PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K061766 03/09/2007 EXPRESSWAY INTERMITTENT CATHETER PERCUTANEOUS SYSTEMS, INCORPORATED THOMAS LAWSON
K070545 03/23/2007 K-Y BRAND WARMING LIQUID PERSONAL PRODUCTS CO. NADER FOTOUHI
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K070588 03/20/2007 PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K070528 03/09/2007 PHILIPS ESSENTA DR PHILIPS MEDICAL SYSTEMS GMBH, DMC LYNN HARMER
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K070551 03/29/2007 MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K063578 03/02/2007 PROMOS MODULAR SHOULDER SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K063556 03/20/2007 PERIPATCH ENDO-SLEEVE PM DEVICES, INC. TIM VERSPAGEN
K061377 03/28/2007 APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS POINTE SCIENTIFIC, INC. WILLIAM WALTERS
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K062306 03/16/2007 PLASMACON N, PLASMACON L-1, PLASMACON L-2 R2 DIAGNOSTICS, INC. MARC GOLDFORD
K070305 03/07/2007 PRE-LOADED VISICOIL RADIOMED CORPORATION GORDON ROBERTS
K070213 03/21/2007 PERFORMER CBP SYSTEM RAND S.R.L. PREETI JAIN
K062651 03/15/2007 PROCHEM EXT CHEMICAL INTEGRATOR RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY-HANN
K070534 03/27/2007 MODIFICATION TO: OCU-FILM TIP COVER REICHERT, INC. SANDRA BROWN
K060764 03/12/2007 SATURN 3 LASER SYSTEM RESEARCH INSTRUMENTS LTD. GRACE HOLLAND
K063830 03/09/2007 REMSTAR AFLEX CPAP SYSTEM RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K060832 03/13/2007 RETRO-TECH DRESSING RETRO-TECH, LLC GRACE HOLLAND
K053342 03/13/2007 GENGIGEL MOUTHRINSE RICERFARMA SRL PAUL KETTERIDGE
K062720 03/22/2007 S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K070391 03/20/2007 ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY TAYLOR
K070200 03/19/2007 TDM CONTROL SET, MODEL CAT# 04521536 ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K062203 03/14/2007 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP. THERESA AMBROSE BUSH
K070275 03/09/2007 FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE RUBICOR MEDICAL, INC. HUGH MAGEN
K063340 03/06/2007 SAF-T-SYRINGE- 0.5 AND 1ML/CC SAFETY MEDICAL INTERNATIONAL, INCORPORATED FRAN WHITE
K063814 03/07/2007 BP-200 PLUS SCHILLER AG RETO KUETTEL
K060899 03/02/2007 FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE SCHOELLY IMAGING, INC. BONI S BONNEVILLE
K070507 03/29/2007 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW SCIENCE FOR BIOMATERIALS DENIS CLEMENT
K070501 03/22/2007 RUIKE 3421 POWERED WHEELCHAIR SHANGHAI RUIKE SPORTS GOODS CO., LTD. JUNNATA CHANG
K062919 03/20/2007 TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) SHEN WEI (USA), INC. CYNTHIA LIU
K070526 03/23/2007 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K070027 03/22/2007 POWDERED (WHITE) VINYL PATIENT EXAMINATION SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L KATHY LIU
K070026 03/07/2007 POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L KATHY LIU
K070041 03/28/2007 POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L KATHY LIU
K070226 03/09/2007 CARDIOCT SHINA SYSTEMS LTD. ELI M ORBACH
K070629 03/26/2007 FLEX AND LOOP COIL SET 1.5 T SIEMENS MEDICAL SOLUTIONS HELMUT NEUMANN
K070576 03/26/2007 ACUSON X150 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING
K063627 03/20/2007 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) SMART GLOVE CORP. SDN BHD CHO S FONG
K063726 03/06/2007 PLC SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV. DEANA BOUSHELL
K070340 03/15/2007 SECURE ARTERIAL BLOOD SAMPLING SYSTEM SMITHS MEDICAL ASD, INC. BARBARA LAW
K070304 03/27/2007 DIGORA PCT/DIGIPOD SOREDEX PALODEX GROUP OY KAI LANER
K063490 03/15/2007 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 SPACELABS MEDICAL INC. DAVID J GERAGHTY
K063844 03/15/2007 REPROCESSED HEART STABILIZERS AND POSITIONERS STERILMED, INC. DENNIS TOUSSAINT
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K063005 03/23/2007 STRYKER T6 HOODS AND TOGAS STRYKER INSTRUMENTS PAULETTE D JOHNSON
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K063859 03/14/2007 SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA SURGIQUEST, INC. KOUROSH AZARBARZIN
K070139 03/02/2007 WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 SURVIVAIR, INC. RICHARD O WOOD
K063568 03/22/2007 HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL SUZHOU MEDICAL APPLIANCE FACTORY HENRY WOO
K070089 03/02/2007 SYNTERMED LIVE SYNTERMED, INC. KENNETH F VAN TRAIN
K063832 03/07/2007 SYNTHES (USA) ELBOW HINGE FIXATOR SYNTHES (USA) JENNIFER PERKS
K062872 03/13/2007 SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K070208 03/28/2007 SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES SYNTHES (USA) SHERI L MUSGNUNG
K063473 03/08/2007 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K070294 03/01/2007 SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES SYNTHES (USA) SHERI L MUSGNUNG
K063149 03/08/2007 ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) T.O.A.D.S., LLC. DAVID BAUGHMAN
K070472 03/15/2007 CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 TaiDoc Technology Corporation ERICA LI
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K061881 03/14/2007 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM TAKIRON CO., LTD KUNIHIRO HATA
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K063722 03/05/2007 SEKURIT SHARPS COLLECTION CONTAINER TECHEN SAFETY, INC. SID MATHUR
K063618 03/13/2007 TENDERFLOW PERIATRIC ARTERIAL CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP. CHRISTINA L THOMAS
K070423 03/28/2007 TR BAND TERUMO MEDICAL CORP. MARK UNTERREINER
K061412 03/23/2007 THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 THERMO ELECTRON CORP. BOLA NICHOLSON
K063150 03/19/2007 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL THERMO ELECTRON OY PAIVI SORMUNEN
K063647 03/12/2007 CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH THERMO ELECTRON OY PAIVI SORMUNEN
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K062521 03/16/2007 OXALATE URINE CONTROLS (NORMAL AND ELEVATED) THERMO-ELECTRON CORP. MELITA LAMBIRIS
K063599 03/22/2007 PORTI 7 PHYSIOLOGICAL AMPLIFIER TMS INTERNATIONAL BV DAVID W WAGNER
K070215 03/30/2007 TOKUYAMA BOND FORCE TOKUYAMA DENTAL CORPORATION ROBERT A SILVERMAN
K070370 03/09/2007 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K070118 03/07/2007 OTOGRAM, CA3350 TYMPANY, INC. LEX J PEARCE
K062222 03/15/2007 UNITIP HIGH RESOLUTION CATHETER UNISENSOR AG ROBERT N CLARK
K070420 03/19/2007 BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 UNITED STATES ENDOSCOPY GROUP, INC. MICHAEL WOLF
K070162 03/06/2007 FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP PHILIP E AKE
K063815 03/01/2007 VARIAN ESOPHAGUS BOUGIE APPLICATOR VARIAN MEDICAL SYSTEMS VY TRAN
K070216 03/16/2007 VARI-LASE BRIGHT TIP FIBER VASCULAR SOLUTIONS, INC. DEBORAH L NEYMARK
K070248 03/01/2007 VELOCITYAIS VELOCITY MEDICAL SOLUTIONS, LLC PAUL SUMNER
K070563 03/16/2007 VIDAR VISION 2000 VIDAR SYSTEMS CORP. JAMES M TAYLOR
K070052 03/28/2007 MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION VILEX, INC. ABRAHAM LAVI
K070487 03/16/2007 SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX VOLCANO CORPORATION CYNTHIA VAN DUKER
K070204 03/23/2007 LINK TO ACUITY CLINICIAN NOTIFIER WELCH ALLYN PROTOCOL, INC. JEFFREY WAGNER
K062214 03/01/2007 BRACHYSCIENCES STRANDPORT WORLDWIDE MEDICAL TECHNOLOGIES, LLC WAYNE W RICHARDSON
K063128 03/21/2007 ADVANCE SPIKED POROUS TIBIAL BASE WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K063731 03/02/2007 ADVANCE STATURE FEMORAL COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K070525 03/29/2007 CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K070308 03/12/2007 FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR X-CEL CONTACTS KEVIN RANDALL
K063186 03/21/2007 ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K070214 03/16/2007 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM ZIMMER, INC. BRANDON HIPSHER
K070205 03/23/2007 ZIOSTATION ZIOSOFT, INC. MARC GOODMAN


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