FDA 510(k) Decisions During May, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K071077 05/18/2007 .DECIMAL APERTURE .DECIMAL, INC. DANIEL BENNETT
K071078 05/22/2007 .DECIMAL RANGE COMPENSATOR .DECIMAL, INC. DANIEL BENNETT
K062070 05/08/2007 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR 3M COMPANY DIANNE GIBBS
DEN060009 05/08/2007 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR 3M COMPANY DIANNE GIBBS
K070956 05/22/2007 SEA2 SELF ETCH ADHESIVE 3M ESPE DENTAL PRODUCTS KAREN O'MALLEY
K062979 05/30/2007 THYROSAMPLER ACD MEDICAL INNOVATION CORP. Kevin Walls
K070289 05/04/2007 ACQUASEAL BENZ ACQUAMED TECHNOLOGIES, INC. HUGH PALMER
K070396 05/22/2007 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 ACUMEN MEDICAL, INC. Marybeth Gamber
K071014 05/24/2007 MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS YOGI SHAH
K070642 05/07/2007 AERONEB PROFESSIONAL NEBULIZER SYSTEM AEROGEN (IRELAND) LTD FRANK ENRIGHT
K071162 05/08/2007 AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS AGFA HEALTHCARE CORP. JEFFERY A JEDLICKA
K063545 05/07/2007 MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE ALFA SCIENTIFIC DESIGNS, INC. DAITING RONG
K070120 05/03/2007 AUTOVENT MODEL 4000 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K062826 05/22/2007 AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS ALPHA-OMEGA SERVICES, INC. BOB A BOBNETT
K062823 05/29/2007 AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K062825 05/22/2007 AOS MARKER SEEDS ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K070681 05/04/2007 NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K063668 05/18/2007 ROC LUMBAR SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K071185 05/30/2007 MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE AMBU A/S SANJAY PARIKH
K070993 05/09/2007 TOPAS SYSTEM AMERICAN MEDICAL SYSTEMS, INC. SARAH PETERSON
K061257 05/04/2007 DBEST HCG PANEL TEST KIT AMERITEK USA, INC. K C YEE
K070829 05/09/2007 SYNEPIX 4600 DETECTOR ANALOGIC CORPORATION DONALD J SHERRATT
K061943 05/25/2007 ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM ANATOMICA AB MARCOS VELEZ-DURAN
K070615 05/04/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K071206 05/31/2007 ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K070990 05/18/2007 APEX MEDICAL MOBINEB, 9R-027 SERIES APEX MEDICAL CORP. ALAN CHANG
K070609 05/04/2007 APEX MEDICAL XT1 CPAP, MODEL 9S-005 APEX MEDICAL CORP. ALAN CHANG
K070651 05/30/2007 ARAGON SURGICAL LAPCAP ARAGON SURGICAL INC. ALAN CURTIS
K062525 05/16/2007 REPROCESSED LIGASURE VESSEL SEALER/DIVIDER ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K070755 05/08/2007 INTERWORKS AVREO, INC. NANCY BUTCHER
K070831 05/22/2007 VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION BARCOVIEW MIS EDINBURGH NEIL PHILLIPS
K070726 05/02/2007 NIO COLOR 3MP AND MDNC 3120 BARCOVIEW, MEDICAL IMAGING SYSTEMS LIEVEN DE WANDEL
K071095 05/18/2007 ASPIRA PLEURAL DRAINAGE SYSTEM BARD ACCESS SYSTEMS, INC. JIHYUN KIM
K071222 05/25/2007 INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K070626 05/04/2007 SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT BECKMAN COULTER, INC. TARA VIVIANI
K063318 05/03/2007 MONOLISA ANTI-HAV EIA Bio-Rad Laboratories MANUELA KAUL
K063319 05/03/2007 MONOLISA ANTI-HAV IGM EIA Bio-Rad Laboratories MANUELA KAUL
K070452 05/07/2007 VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU BIO-RAD LABORATORIES, INC. JACKIE H BUCKLEY
K071091 05/17/2007 MODIFICATION TO BILOK SCREW BIOCOMPOSITES LTD. SIMON FITZER
K071115 05/17/2007 MODIFICATION TO BILOK ST SCREW BIOCOMPOSITES LTD. SIMON FITZER
K061323 05/23/2007 MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM BIOINFERA, INC. CHAN Q WANG
K071295 05/16/2007 100W CERALAS D 980NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K061385 05/30/2007 OSSTAPLE, OSSPLATE, OSSFORCE BIOMEDICAL ENTERPRISES, INC W. CASEY FOX
K070147 05/14/2007 INTERGRO ORAL BIOMET 3I TAMARA J NELSON
K070399 05/04/2007 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES BIOMET MANUFACTURING, INC. TRACY B JOHNSON
K070823 05/07/2007 GROWTH CONTROL PLATING SYSTEM BIOMET TRAUMA SUSAN ALEXANDER
K070364 05/03/2007 100KGY E-POLY MAXROM ACETABULAR LINERS BIOMET, INC. TRACY BICKEL JOHNSON
K070240 05/04/2007 CARTO XP EP NAVIGATION SYSTEM, VERSION 9 BIOSENSE WEBSTER, INC. NEELU MEDHEKAR
K070242 05/15/2007 SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 BIOSENSE WEBSTER, INC. NEELU MEDHEKAR
K070324 05/03/2007 IPC-BOOT C-BOOT LTD. AVI ABRAHAM
K070996 05/08/2007 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K071204 05/18/2007 SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 C.R. BARD, INC. KIMBERLY GEISLER
K070235 05/18/2007 BODYGUARD PAIN MANAGER INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. SHLOMI DINES
K070070 05/25/2007 ASCENT DENTAL CLEANSER CAO GROUP, INC. ROBERT K LARSEN
K071108 05/24/2007 TEXIUM SYRINGE CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K070740 05/07/2007 CHAD THERAPEUTICS BONSAI MODEL 800 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K063269 05/23/2007 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K070054 05/04/2007 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST CHURCH & DWIGHT CO., INC. CYNTHIA DAVIDSON
K071355 05/24/2007 SMARTSPONGE SYSTEM CLEARCOUNT MEDICAL SOLUTIONS, INC. STEVEN FLECK
K070741 05/04/2007 CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 CLINIQA CORPORATION CAROL RUGGIERO
K070814 05/30/2007 MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP CONFLUENT SURGICAL,INC KRISTINE BURKE
K070628 05/01/2007 OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. CONTAMAC LTD. MARTIN DALSING
K063742 05/08/2007 RESONANCE METALLIC URETERAL STENT COOK IRELAND LTD SINEAD BURKE
K071189 05/16/2007 CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER CORDIS EUROPA, N.V. HARM HOVINGA
K062025 05/29/2007 ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 CORGENIX, INC. KIMBERLY N HASSLER
K070893 05/01/2007 CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 CSA MEDICAL, INC. JENNIFER CARTLEDGE
K062572 05/11/2007 CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE CUSTOM SCIENTIFIC PATSY J TRISLER
K070860 05/11/2007 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN DADE BEHRING, INC. ROBERT EUSEBIO
K071076 05/21/2007 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K070529 05/08/2007 AFF (MARK I) VOLUMETRIC INFUSION PUMP DEFINITIVE MEDICAL TECHNOLOGIES, LTD. BOAZ BARTOV
K070124 05/23/2007 GASTROSTOMY REPLACEMENT TUBE, MODEL 253 DEGANIA SILICONE, LTD. ZOYA LEE
K070693 05/09/2007 AURAVUE PIT & FISSURE SEALANT DENALI CORPORATION JAN G STANNARD
K070702 05/10/2007 FUSION RESIN CEMENT AND CORE KIT DENALI CORPORATION JAN G STANNARD
K070307 05/02/2007 STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K070925 05/02/2007 MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K071135 05/23/2007 DEPUY CI HIP INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K071117 05/18/2007 MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. Natalie Heck
K070994 05/09/2007 EAGLE + ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. FRANK S JURCZAK
K070568 05/25/2007 DIO PROTEM IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. KENNY LIM
K070536 05/21/2007 MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC. Tim Thomas
K070692 05/30/2007 DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK DUKAL CORPORATION PATRICK J LAMB
K062724 05/11/2007 ACCUPULSE PULSE OXIMETER EAGLE MEDICAL EQUIPMENT CO. JAMES A DUNNING
K070427 05/14/2007 DUPEL TRANSPORT IONTOPHORESIS SYSTEM EMPI SANDRA WALROD
K070050 05/23/2007 VITALITY HIP SYSTEM MODEL#420 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K070193 05/02/2007 ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES ENVITEC-WISMAR GMBH STEPHEN GORSKI
K071028 05/01/2007 VIEWMATE SYSTEM EP MEDSYSTEMS LARRY PICCIANO
K070494 05/01/2007 EPI-C PLUS ESPANSIONE MARKETING SPA GUIDO BONAPACE
K070887 05/25/2007 ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K070763 05/22/2007 EUROIMMUN ANA IFA: HEP-20-10 EUROIMMUN US LLC KATHRYN KOHL
K070239 05/25/2007 MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM EXIR PHARMACEUTICAL CO. ERICA LI
K062563 05/18/2007 FEMTEN CERVICAL TENACULUM FEM SUITE, L.L.C. CARL YOUNGMANN
K063363 05/07/2007 FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE FLEXICATH LTD. AHAVA STEIN
K070920 05/22/2007 FUJI IP CASSETTE TYPE PC FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K070393 05/04/2007 LAGWIRE SYSTEM FXDEVICES RICH LIPSCHUTZ
K070840 05/15/2007 GVC-100 GC AMERICA, INC. TERRY L JORITZ-LYONS
K071073 05/11/2007 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KAREN M LUNDE
K063042 05/30/2007 CARDIOMEM CM 3000-12BT GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG SID MATHUR
K070475 05/07/2007 MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K052480 05/02/2007 HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH HANSEN MEDICAL, INC. NINA PELED
K071018 05/25/2007 MONARCH NASAL IMPLANT HANSON MEDICAL, INC. GERALD HANSON
K071006 05/21/2007 HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K071005 05/22/2007 HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K070593 05/07/2007 TRACKRECORD DATA MANAGEMENT SOFTWARE HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K070861 05/15/2007 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE HONG XIN RUBBER PRODUCTS CO., LTD KATHY LIU
K063104 05/16/2007 FOX MEDICAL DIODE LASER SYSTEM 810NM HOWARD INSTRUMENTS, INC. JACK HOWARD
K070963 05/04/2007 REUNION HA FRACTURE STEM HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K070885 05/16/2007 UNIVERSAL TAPER DELTA FEMORAL HEAD HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K071092 05/11/2007 ASNIS MICRO CANNULATED SCREW HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K070883 05/11/2007 DURACON X3 CS TIBIAL INSERT HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K071188 05/21/2007 MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K071099 05/22/2007 NEURO II-SE, MODELS: OR-DR-OR, OR-MB IMRIS, INC. THOMAS M TSAKERIS
K070801 05/24/2007 IMM HYPODERMIC NEEDLE SET INNOVATIVE MEDICAL MANUFACTURING CO. JOSEPH J CHANG
K071301 05/24/2007 ANTLIA I WOUND IRRIGATION SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K070724 05/16/2007 IOS EXTERNAL FIXATOR, MODEL 2-0-0 INTELLIGENT ORTHOPAEDICS LTD Neil McLachlan
K062149 05/31/2007 SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES INTERNATIONAL BUSINESS STRATEGIES BILL ROETTGER
K071000 05/14/2007 MYRIAN INTRASENSE NICOLAS CLARY
K070646 05/11/2007 ADHESE ONE IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K070074 05/31/2007 LUBRINA, MODEL HIM-1 J. MORITA USA, INC. KEITH A BARRITT
K070234 05/22/2007 JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS JMS NORTH AMERICA CORP. SWEE CHEAU CHONG
K070229 05/03/2007 RANGE SPINAL SYSTEM K2M, INC. RICHARD W WOODS
K070830 05/08/2007 MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) KAREX INDUSTRIES SDN BHD LENG KIAN GOH
K070716 05/31/2007 IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K070827 05/22/2007 KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K070752 05/01/2007 KSEA MINIATURE ENDOSCOPE, MODEL 11565 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL K DIZOL
K070353 05/02/2007 KELSEY INTERSITITAL LASER THERAPY SYSTEM KELSEY, INC. PAUL KETTERIDGE
K071181 05/30/2007 DIRECT DIGITIZER, REGIUS MODEL 110 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K062096 05/07/2007 KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST KOREAMEDICO CO. LTD. KIM YOUNG-YONG
K071338 05/29/2007 FLEX ARM RETRACTOR SYSTEM KOROS USA, INC. GABRIEL KOROS
K070331 05/04/2007 UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES LABORIE MEDICAL TECHNOLOGIES BARBARA MORNET
K063802 05/07/2007 LENSTEC LC INJECTION SYSTEM LENSTEC, INC. JIMMY CHACKO
K070974 05/24/2007 LIGHT RELIEF, MODEL LR150, LR200 LIGHT RELIEF, LLC LAURIE MCLAUGHLIN
K070825 05/25/2007 LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING David Zhang
K071231 05/17/2007 EDAC QUANTIFIER LUNA INNOVATIONS, INC. KRISTINE RICHARDSON
K070557 05/23/2007 MP 719 MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K070003 05/15/2007 POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) MEDCOMP JEAN CALLOW
K070868 05/15/2007 LMS-LUNG/TRACK MEDIAN TECHNOLOGIES CHAS BURR
K070821 05/10/2007 POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG
K070286 05/22/2007 BIO-CONSOLE, MODEL 560 Medtronic CHERYL NORTON
K070527 05/04/2007 ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K070562 05/18/2007 EZ PLUS IMPLANT SYSTEM MEGAGEN CO., LTD. DAE K CHANG
K070441 05/08/2007 METASURG SUBTALAR IMPLANT METASURG LARRY WEATHERFORD
K070456 05/24/2007 MICRUS COURIER ENZO MICROCATHETER 0.017 MICRUS ENDOVASCULAR CORPORATION R. MICHAEL CROMPTON
K070313 05/11/2007 MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. RONALD R MANNA
K070347 05/11/2007 ALLOFIX PUSH-IN ANCHOR MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY L BENNEWITZ
K062731 05/01/2007 ULTRASONIC SCALER, VARIOS 560 NAKANISHI, INC. NORIMASA KANEKO
K070934 05/22/2007 PANOSOL II TRU-BLU, MODEL UBL-417 NATIONAL BIOLOGICAL CORP. GEORGE KRINER
K070408 05/25/2007 DURAMAX REUSABLE OXIMETRY SENSOR NELLCOR PURITAN BENNETT, INC. JAMES BONDS
K071311 05/22/2007 NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL NEOCOIL BRIAN BROWN
K070416 05/29/2007 NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP NEOFORCE GROUP, INC. MARY STANIEWICZ
K062943 05/09/2007 POLYSMITH SLEEP SYSTEM, MODEL NTI5498 NEUROTRONICS, INC. JENNIFER LAINE
K071154 05/10/2007 SUPERSTAR 0.35T MRI SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD.
K063693 05/11/2007 FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST NEW BAY BIORESEARCH CO. LTD. RODRIGO BERLIE
K070688 05/18/2007 NEXFIX COMPRESSION STAPLE NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K071081 05/01/2007 CONTACT LENS CASE NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT Diana Hong
K063752 05/04/2007 LIFESENSE, MODEL LS1-9R NONIN MEDICAL, INC. LORI M ROTH
K070014 05/25/2007 AUTO DETECT FOR TELAHEART DR200/E-A NORTHEAST MONITORING, INC. JOSEPH AZARY
K070068 05/07/2007 NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS NOVA BIOMEDICAL CORP. PAUL W MACDONALD,PHD
K071037 05/10/2007 SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K071267 05/18/2007 PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. ROBERT G ROTHFRITZ
K070047 05/18/2007 NUNC IVF DISHES AND NUNC IVF 4-WELL DISH NUNC A/S JANA S HELLMANN
K070834 05/18/2007 CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) OMEGA MEDICAL IMAGING, INC. JAMES A PRINCEHORN
K070575 05/29/2007 EVICEL APPLICATION DEVICE OMRIX BIOPHARMACEUTICALS LTD. DAVID NAKAR
K063690 05/09/2007 COLIN PRESS MATE, MODEL BP S510 OMRON HEALTHCARE, INC. RANNDY KELLOGG
K063454 05/09/2007 POGS, MODEL 33C ON SITE GAS SYSTEMS, INC. GUY HATCH
K062171 05/25/2007 EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES ORTHO DEVELOPMENT CORP. JOHANNE YOUNG
K071216 05/25/2007 VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc. MICHAEL M BYRNE
K071215 05/25/2007 VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 Ortho-Clinical Diagnostics, Inc. MICHAEL M BYRNE
K071243 05/23/2007 METAL HEMI IMPLANT ORTHOPRO LLC J.D. WEBB
K071173 05/25/2007 RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D OSSUR AMERICANS (FORMERLY THE JEROME GROUP) BERNIE TATRO
K062192 05/24/2007 OSTIAL PRO STENT POSITIONING SYSTEM OSTIAL SOLUTIONS, LLC MICHAEL J BILLIG
K070318 05/11/2007 SKIPPI POWERED WHEELCHAIR FOR CHILDREN OTTO BOCK HEALTHCARE, LP SHANNON TUFVANDER
K071152 05/25/2007 PALOMAR ERBIUM HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE, RAC, CCRA
K070637 05/01/2007 FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES PARAGON VISION SCIENCES WILLIAM E MEYERS
K071065 05/04/2007 ORTHADAPT BIOIMPLANT PEGASUS BIOLOGICS, INC. PAMELA MISAJON
K070807 05/23/2007 CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES PEPIN MFG., INC. Gary Syring
K063137 05/01/2007 PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 PHARMASMART, INC. IAN GORDON
K070715 05/07/2007 NASOPORE EAR Polyganics BV JAN NIEUWENHUIS
K070363 05/11/2007 FETCH ASPIRATION CATHETER POSSIS MEDICAL, INC. FRANK B FREEDMAN
K070997 05/16/2007 DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX PRO-MED INSTRUMENTS GMBH EDGAR SCHUELE
K063494 05/21/2007 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS PRO-MED INSTRUMENTS GMBH EDGAR SCHUELE
K063202 05/02/2007 PRODERMA LIQUID BANDAGE PROCUREMENT TECHNOLOGY SYSTEMS, LLC WILLIAM J GRISWOLD
K070931 05/24/2007 MODEL PMT850 PROMEDTEK, INC. DIANE MANDELL
K070862 05/30/2007 POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) PURTECH CLEANROOM PRODUCTS CO., LTD. KATHY LIU
K071008 05/09/2007 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL SCOTT A WILSON
K063584 05/09/2007 STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 REGENERATION TECHNOLOGIES, INC. Lisa Simpson
K070284 05/17/2007 FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) RELIANT TECHNOLOGIES, INC. HEATHER MACFALLS
K070739 05/25/2007 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 RENAL SOLUTIONS INC. DAVID J VANELLA
K063661 05/25/2007 RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 RENU MEDICAL, INC. BRUCE PIERSON
K070328 05/08/2007 BIPAP SYNCHRONY WITH AVAPS RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K070180 05/18/2007 WALLABY 4 RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K071041 05/11/2007 COAGUCHEK XS PLUS SYSTEM Roche Diagnostics THERESA BUSH
K070585 05/25/2007 ACCU-CHEK PERFORMA SYSTEM ROCHE DIAGNOSTICS CORP. Scott Thiel
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K071048 05/15/2007 RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 RUBICOR MEDICAL, INC. ROBERT J CHIN
K070388 05/02/2007 PROFILE MULTI-PLATFORM SYSTEM SCITON, INC. JAY M PATEL
K062784 05/04/2007 SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. PAUL WARE
K071229 05/18/2007 SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY SENORX, INC. EBEN GORDON
K070086 05/10/2007 SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR SENSACARE LTD. STEVEN CHANG
K070971 05/23/2007 MODIFICATION TO SENTINEL CLIN CHEM CAL SENTINEL CH. SRL FABIO ROTA
K063634 05/11/2007 RTR SYRINGE SEPTODONT WAYNE H MATELSKI
K070645 05/17/2007 SERADYN QMS TOPIRAMATE SERADYN INC. JACK ROGERS
K070982 05/02/2007 CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K063743 05/24/2007 RHYTHM TOUCH Q 2-WAY SHOCKIM ENTERPRISES, LTD. NICOLAAS C BESSELING
K071114 05/22/2007 SYNGO IMAGING (VERSION V30) SIEMENS AG, MEDICAL SOLUTIONS EVA REITER
K071017 05/02/2007 IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS DEBORAH L MORRIS
K071068 05/14/2007 BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 SIEMENS MEDICAL SOLUTIONS USA, INC. CRISTIN WETHERBEE
K071015 05/10/2007 OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY RENDON
K071314 05/22/2007 SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. MARTINA VOGT
K071036 05/16/2007 MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI MARTINA VOGT
K063806 05/17/2007 SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED SLEEPNET CORPORATION PAUL CHIESA
K070793 05/30/2007 SBI DISTAL RADIUS VOLAR PLATING SYSTEM SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K070908 05/16/2007 SMITH & NEPHEW KINSA RC SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIVISION DEANA BOUSHELL
K070565 05/18/2007 COFIELD TOTAL SHOULDER SYSTEM SMITH & NEPHEW, INC. MARLON D RIDLEY
K070116 05/23/2007 POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE SMITHS MEDICAL MD, INC. PHIL NEURURER
K071134 05/08/2007 SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K071061 05/16/2007 ABSORBATACK AND APPLICATOR SORBX, LLC MARY LEE WILLETS
K070905 05/24/2007 ENDOSSEOUS DENTAL IMPLANT SYSTEM SOUTHERN IMPLANTS, INC. GRETA M HOLS
K063764 05/16/2007 SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM SOUTHERN SPINE, LLC JULIE STEPHENS
K070595 05/24/2007 SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR SPSMEDICAL SUPPLY CORP. GARY SOCOLA
K063638 05/11/2007 MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 ST. JUDE MEDICAL SHANNON SPRINGER
K070902 05/01/2007 MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 ST. JUDE MEDICAL KAREN J MCKELVEY
K063789 05/10/2007 WN SYNOCTA GOLD ABUTMENT STRAUMANN USA ELAINE ALAN
K063480 05/22/2007 STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 STRYKER CORP. JEAN SHEPPARD
K070368 05/04/2007 TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM STRYKER CORP. SIMONA VOIC
K070758 05/16/2007 STRYKER PEEK ZIP SUTURE ANCHOR Stryker Endoscopy ERICA A WALTERS
K070457 05/16/2007 SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB SUN SCIENTIFIC LLC JOSEPH AZARY
K070750 05/02/2007 247 BP DEVICE SUNTECH MEDICAL, INC. CHUCK SETZER
K063680 05/09/2007 SHARPOINT PDO (POLYDIOXANONE) SUTURES SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K070678 05/02/2007 DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST SWISSRAY INTERNATIONAL, INC. JOHN MONAHAN
K070327 05/25/2007 REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K063489 05/23/2007 STRYKER INTRADISCAL RF GENERATOR SYNERGETICS, INC. DAN REGAN
K070843 05/02/2007 SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K070910 05/25/2007 SYSMEX MODEL UF1000I SYSMEX AMERICA, INC. NINA M GAMPERLING
K070713 05/02/2007 IMPLANT LOCATION SOFTWARE-T TACTILE TECHNOLOGIES, LTD. URIEL WEINSTEIN
K070561 05/25/2007 KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES TELEFLEX MEDICAL LORI HAYS
K071075 05/25/2007 TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A TERUMO CORP. YOSHIAKI NAGURA
K070264 05/29/2007 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB TERUMO EUROPE N.V. M.J. AERTS
K070362 05/07/2007 SURFLO WINGED INFUSION SET TERUMO EUROPE N.V. M J AERTS
K070547 05/25/2007 SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) TERUMO EUROPE N.V. M.J. AERTS
K062475 05/09/2007 LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM THE LARYNGEAL MASK CO.,LTD. FOSTER BOOP
K070638 05/30/2007 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC DALE DAVISON
K070064 05/22/2007 AMYLASE EPS REAGENT Thermo Fisher Scientific MELITA LAMBIRIS
K070024 05/16/2007 THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE THOR INTERNATIONAL M. JOYCE HEINRICH
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K070612 05/07/2007 TOP-RANK ADHESIVE ELECTRODE TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. UWE DEGENHARDT
K070295 05/21/2007 SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM TRINITY ORTHOPEDICS, LLC FLOYD G LARSON
K071106 05/08/2007 ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 ULTRADENT PRODUCTS, INC. COREY JASEPH
K071055 05/03/2007 OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 ULTRADENT PRODUCTS, INC. ROBERT WANG
K070591 05/11/2007 REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH UNION DENTAL S.A./UNIDESA.ODI JOSE LUIS RODRIGUEZ
K063611 05/23/2007 SALINE/ CONTRAST MEDIA INFUSION CATHETER UTAH MEDICAL PRODUCTS, INC. KEVIN L CORNWELL
K070446 05/02/2007 COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP JULIE ROSS
K071217 05/17/2007 BLADDERSCAN BVI 9400 ULTRASOUND VERATHON INCORPORATED RUSS GARRISON
K070614 05/04/2007 CORSCREEN VIASYS HEALTHCARE GMBH DETLEF GROTHEER
K062011 05/11/2007 MODIFICATION TO FLOWSCREEN VIASYS HEALTHCARE GMBH Yvette Lloyd
K070759 05/21/2007 POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM VIDACARE CORPORATION GRACE HOLLAND
K071193 05/30/2007 VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS VIDAR SYSTEMS CORP. DANIEL KAMM
K071362 05/30/2007 VITAL CONNECT 4.1 VITAL IMAGES, INC. TIMOTHY J KAPPERS, MBA,RAC
K071331 05/25/2007 VITREA VERSION 4.0 VITAL IMAGES, INC. TIMOTHY J KAPPERS
K071054 05/22/2007 RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 VOLUME INTERACTIONS PTE LTD MICHAEL SIM
K063367 05/23/2007 45L CORE INSUFFLATOR, MODEL F114 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K063868 05/25/2007 MASSTRAK IMMUNOSUPPRESSANTS KIT WATERS CORPORATION FRAN WHITE
K070964 05/18/2007 KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM WELCH ALLYN, INC. CHRIS HORACEK
K070431 05/24/2007 WELMED, INC. SURGICAL GOWNS WELMED INC. Glen Feye
K070326 05/05/2007 NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM WIDEMED LTD DORIT WINITZ
K060968 05/15/2007 STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW WORTHAM LABORATORIES INC LEON WORTHAM
K071040 05/22/2007 WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS WRIGHT LINEAR PUMP, INC. CAROL WRIGHT
K070437 05/09/2007 PRO-DENSE BONE VOID FILLER WRIGHT MEDICAL TECHNOLOGY, INC. RYAN M BELANEY
K070473 05/23/2007 BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX ZEN STRONG MEDICAL TECHNOLOGY CO., LTD CHENG ROEI-SHENG
K070677 05/11/2007 COLORISE ZHERMACK S.P.A. GERALD W SHIPPS
K071235 05/30/2007 ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 ZIMMER DENTAL INC. WILLIAM FISHER
K070382 05/30/2007 VISTA -S DEVICE ZIMMER TRABECULAR METAL TECHNOLOGY JENNIFER P HARAKAL
K070906 05/01/2007 MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS ZIMMER, INC. MASON W ROBBINS


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