FDA 510(k) Applications Received During March, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K070663 03/09/2007 A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT A-DEC, INC. THOMAS H LOUISELL
K070850 03/28/2007 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. DHRUMA SHAH
K070581 03/01/2007 SILVER ALGINATE II WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED GRAHAME SOMERVILLE
K070847 03/28/2007 TRIAL CABLE, 3009 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K070642 03/08/2007 AERONEB PROFESSIONAL NEBULIZER SYSTEM AEROGEN (IRELAND) LTD FRANK ENRIGHT
K070675 03/12/2007 MAMMAPRINT AGENDIA BV Guido Brink
K070722 03/15/2007 PLASMAIR, MODEL T2006 AIRINSPACE B.V. WADE TETSUKA
K070660 03/09/2007 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. MAJID PAJOUH
K070636 03/07/2007 AUTOVENT 4000 WITH CPAP ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K070681 03/12/2007 NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K070891 03/30/2007 ALTIVA CLASSIC ACP SYSTEM ALTIVA CORP. JOHN KAPITAN
K070873 03/29/2007 AMSURE BLADDER IRRIGATION SET AMSINO INTL., INC. YI CHEN
K070829 03/26/2007 SYNEPIX 4600 DETECTOR ANALOGIC CORPORATION DONALD J SHERRATT
K070803 03/23/2007 INVIVODENTAL ANATOMAGE, INC ROBERT J CHIN
K070613 03/05/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K070615 03/05/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K070610 03/05/2007 SKATER BILIARY CATHETER ANGIOTECH TRUDY ESTRIDGE
K070800 03/23/2007 LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM ANSELL HEALTHCARE PRODUCTS LLC LON D MCILVAIN
K070609 03/05/2007 APEX MEDICAL XT1 CPAP, MODEL 9S-005 APEX MEDICAL CORP. ALAN CHANG
K070865 03/29/2007 EXPANDING VASCULAR SHEATH APPLIED MEDICAL CHERYL BLAKE
K070651 03/09/2007 ARAGON SURGICAL LAPCAP ARAGON SURGICAL INC. ALAN CURTIS
K070874 03/29/2007 ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR ARTHRO KINETICS INC. JAMES HOBBS
K070851 03/28/2007 ARTHROCARE SPINEWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070671 03/12/2007 OPUS SMARTSTITCH SUTURE DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K070866 03/29/2007 ASC-12 PIEZOELECTRIC SCALER ASEPTICO, INC. GRANT RAMALEY
K070795 03/22/2007 SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM ATCOR MEDICAL PTY. LTD EVAN P PHELPS
K070833 03/27/2007 ATLANTIS ABUTMENT FOR ASTRA IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K070755 03/19/2007 INTERWORKS AVREO, INC. NANCY BUTCHER
K070773 03/21/2007 AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K070831 03/26/2007 VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION BARCOVIEW MIS EDINBURGH NEIL PHILLIPS
K070726 03/15/2007 NIO COLOR 3MP AND MDNC 3120 BARCOVIEW, MEDICAL IMAGING SYSTEMS LIEVEN DE WANDEL
K070626 03/06/2007 SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT BECKMAN COULTER, INC. TARA VIVIANI
K070691 03/13/2007 BBL CHROMAGAR 0157 BECTON, DICKINSON & CO. DENNIS R MERTZ
K070809 03/26/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K070654 03/09/2007 HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K070819 03/26/2007 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI JACKIE H BUCKLEY
K070848 03/28/2007 LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X BIO-RAD, DIAGNOSTICS GRP. ELIZABETH PLATT
K070810 03/26/2007 ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) BIOKIT S.A. JOAN GUIXER
K070624 03/06/2007 HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. GEORGE J HATTUB
K070659 03/09/2007 BIOLUCENT APPLICATOR KIT BIOLUCENT, INC. DAVE CAMPBELL
K070864 03/28/2007 BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER BIOMET OSTEOBIOLOGICS PALANISWAMY VIJAY
K070823 03/26/2007 GROWTH CONTROL PLATING SYSTEM BIOMET TRAUMA SUSAN ALEXANDER
K070710 03/14/2007 ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM BIOSENSORS INTERNATIONAL-USA Sara Toyloy
K070879 03/30/2007 BARD MALECOT AND PEZZER DRAINS C.R. BARD, INC. JOHN KNORPP
K070582 03/01/2007 BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS C.R. BARD, INC. SKIP RIMER
K070603 03/05/2007 C.T.M. MOBILITTY SCOOTER # HS-295 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K070602 03/05/2007 C.T.M. MOBILITY SCOOTER# HS-265 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K070718 03/14/2007 MODIFICATION TO: BODYGUARD INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. SHLOMI DINES
K070647 03/08/2007 TRIFLEX SELECT CARDINAL HEALTH, INC. AMY HOYD
K070680 03/12/2007 CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 CARDIOMEMS, INC. GRACE POWERS
K070888 03/30/2007 COMBI 8 MAX CEC ELECTRONICA S.R.L. BENNY ARAZY
DEN070004 03/12/2007 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.
K070740 03/16/2007 CHAD THERAPEUTICS BONSAI MODEL 800 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K070796 03/23/2007 CHILI PACS CHILI GMBH UWE ENGELMANN
K070627 03/06/2007 OPACIDEN SOLUTION CIDEN TECHNOLOGIES LLC LISA S JONES
K070836 03/27/2007 EXICLIP EXCS-M CLEVEX INC. LENA SATTLER
K070741 03/16/2007 CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 CLINIQA CORPORATION CAROL RUGGIERO
K070798 03/23/2007 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS COEUR, INC. DEBRA F MANNING
K070814 03/26/2007 MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP CONFLUENT SURGICAL,INC KRISTINE BURKE
K070780 03/21/2007 CONMED LINVATEC XO BUTTON CONMED LINVATEC JOY LOVETT
K070628 03/07/2007 OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. CONTAMAC LTD. MARTIN DALSING
K070738 03/16/2007 SIS FACIAL CYLINDER, SIS FACIAL IMPLANT COOK BIOTECH, INC. MARY A FADERAN
K070749 03/19/2007 ESTECH PERCUTANEOUS INSERTION DILATOR KIT COOMBS MEDICAL DEVICE CONSULTING CRAIG COOMBS
K070583 03/01/2007 NANO COMPOSITE COSMEDENT, INC. JAMES L SANDRIK
K070690 03/13/2007 THE LIFE VESSEL COTTONWOOD VESSEL CORPORATION MIKI KOLTON
K070893 03/30/2007 CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 CSA MEDICAL, INC. JENNIFER CARTLEDGE
K070853 03/28/2007 DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 DADE BEHRING, INC. VICTOR M CARRIO
K070860 03/28/2007 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN DADE BEHRING, INC. ROBERT EUSEBIO
K070693 03/13/2007 AURAVUE PIT & FISSURE SEALANT DENALI CORPORATION JAN G STANNARD
K070702 03/13/2007 FUSION RESIN CEMENT AND CORE KIT DENALI CORPORATION JAN G STANNARD
K070869 03/29/2007 PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 DENTALEZ, INC. WILLIAM GUSCOTT
K070849 03/28/2007 DEPUY GCK FEMORAL AND TIBIAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K070760 03/20/2007 POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE DERMA CARE PLUS PRODUCTS LLC JOSEPH NEUSER
K070811 03/26/2007 CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 DEXCO ROBERT MAZZAFERRO
K070734 03/16/2007 MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON DIAZYME LABORATORIES Abhijit Datta
K070704 03/13/2007 TRILOGY ANALYZER DREW SCIENTIFIC, INC. CYNTHIA SINCLAIR
K070692 03/13/2007 DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK DUKAL CORPORATION PATRICK J LAMB
K070584 03/01/2007 SMART-ROD DUOJECT MEDICAL SYSTEMS, INC. CAROLINE LAVOIE
K070855 03/28/2007 SLEEP QUALITY DYNADX CORPORATION EJ Smith
K070658 03/09/2007 DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM E-WOO TECHNOLOGY STEPHEN T MLCOCH
K070706 03/14/2007 EP-WORKMATE EP MEDSYSTEMS LARRY PICCIANO
K070887 03/30/2007 ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K070880 03/30/2007 ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. CAMPBELL L TUSKEY
K070763 03/20/2007 EUROIMMUN ANA IFA: HEP-20-10 EUROIMMUN US LLC KATHRYN KOHL
K070789 03/22/2007 EUROIMMUN ANTI-CCP ELISA EUROIMMUN US LLC KATHRYN KOHL
K070890 03/30/2007 EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 EVERLIFE MEDICAL EQUIPMENT CO., LTD. Ke-Min Jen
K070729 03/15/2007 BALANCEBACK MOBILE INTUITIVE VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC FRANK SCARPINO
K070640 03/07/2007 ARCHITECT STAT TROPONIN-1; MYOGLOBIN FISHER DIAGNOSTICS HEATHER CAMERON
K070617 03/05/2007 CANNULATED SCREW FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K070822 03/26/2007 ARCHITECT SIROLIMUS ASSAY FUJIREBIO DIAGNOSTICS, INC. DIANA LYN DICKSON
K070820 03/26/2007 ARCHITECT TACROLIMUS: MODEL 1L77 FUJIREBIO DIAGNOSTICS, INC. DIANA DICKSON
K070815 03/26/2007 THD G.F. S.R.L. MAUREEN O'CONNELL
K070643 03/08/2007 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 GAMBRO, INC. THOMAS B DOWELL
K070698 03/13/2007 COE COMFORT GC AMERICA, INC. TERRY L JORITZ-LYONS
K070697 03/13/2007 COE SOFT GC AMERICA, INC. TERRY L JORITZ-LYONS
K070854 03/28/2007 GC MI PASTE PLUS GC AMERICA, INC. TERRY L JORITZ-LYONS
K070840 03/27/2007 GVC-100 GC AMERICA, INC. TERRY L JORITZ-LYONS
K070689 03/13/2007 LG SPERM FREEZING GENX INTL., INC. MICHAEL D CECCHI
K070657 03/09/2007 GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER GETINGE SOURCING LLC ANN WHEELER
K070775 03/21/2007 MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K070630 03/07/2007 HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE HEALTH LINE INTERNATIONAL CORPORATION (HLIC) DENICE WROE
K070593 03/02/2007 TRACKRECORD DATA MANAGEMENT SOFTWARE HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K070861 03/28/2007 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE HONG XIN RUBBER PRODUCTS CO., LTD KATHY LIU
K070885 03/30/2007 UNIVERSAL TAPER DELTA FEMORAL HEAD HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K070883 03/30/2007 DURACON X3 CS TIBIAL INSERT HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K070633 03/07/2007 GENIE, MODEL CH-200 ICU MEDICAL, INC TRACY BEST
K070856 03/28/2007 ICU MEDICAL SINGLE-USE SYRINGE ICU MEDICAL, INC TRACY S BEST
K070784 03/21/2007 INION BIORESTORE INION OY KATI MARTINEN
K070801 03/23/2007 IMM HYPODERMIC NEEDLE SET INNOVATIVE MEDICAL MANUFACTURING CO. JOSEPH J CHANG
K070867 03/29/2007 INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS LLC RICHARD K BOURNE
K070744 03/16/2007 NARROW NECK TEMPORARY COPING INSTITUT STRAUMANN AG ELAINE ALAN
K070635 03/07/2007 HEMOSIL PROCLOT INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K070608 03/05/2007 SMARTEP, MODEL M010000 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K070724 03/15/2007 IOS EXTERNAL FIXATOR, MODEL 2-0-0 INTELLIGENT ORTHOPAEDICS LTD Neil McLachlan
K070696 03/13/2007 INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) INTERACOUSTICS A/S DANIEL EGGAN
K070601 03/02/2007 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
DEN070006 03/23/2007 BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX Anne Jepson
K070751 03/19/2007 ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY ISOTIS ORTHOBIOLOGICS, INC KARON MORELL
K070646 03/08/2007 ADHESE ONE IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K070587 03/01/2007 ELEGANCE WOMAN'S LUBRICANT JULIE WILLIAMS, PA-C JULIE WILLIAMS
K070830 03/26/2007 MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) KAREX INDUSTRIES SDN BHD LENG KIAN GOH
K070716 03/14/2007 IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K070827 03/26/2007 KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K070752 03/19/2007 KSEA MINIATURE ENDOSCOPE, MODEL 11565 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL K DIZOL
K070579 03/01/2007 STORZ SLX-F2 STORM TOUCH KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K070606 03/05/2007 VISIO+CD VIEWER# KPSCDVE01 KEOSYS S.A.S. ANTHONY MOTTIER
K070828 03/26/2007 KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K070826 03/26/2007 KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K070767 03/20/2007 EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION LAPIS LAZULI INTERNATIONAL NV MARTIN DALSING
K070817 03/26/2007 LERADOTECH SCOOTER, MODEL SB LERADO CHINA LIMITED Ke-Min Jen
K070802 03/23/2007 LERADOTECH, MODEL SC LERADO CHINA LIMITED JUNNATA CHANG
K070825 03/26/2007 LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING David Zhang
K070605 03/05/2007 JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K070625 03/06/2007 PELVIMESH / HERMESH 7 MARKETING SOLUTIONS INC. LORENA TRABUCCO
K070868 03/29/2007 LMS-LUNG/TRACK MEDIAN TECHNOLOGIES CHAS BURR
K070794 03/22/2007 ATLANTIK MEDICAL BIOMAT AURELIEN BIGNON
K070858 03/28/2007 EXPRESS SERIES MEDICAL GRAPHICS CORP. MARY E DONLIN
K070669 03/12/2007 IOL INJECTOR SET MEDICEL AG GEORGE MYERS
K070730 03/15/2007 FLEX-NECK ARC CATHETER MEDIGROUP, INC. JOHN A NAVIS
K070714 03/14/2007 MEDISIZE GOLD HEATER AND BOOSTER MEDISIZE BV SOPHIA LAM
K070813 03/26/2007 ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K070821 03/26/2007 POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG
K070886 03/30/2007 MEROGEL INJECTABLE BIORESORBABLE STENT MEDTRONIC INC. JAYME WILSON
K070742 03/16/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K070648 03/08/2007 THE INHIBITOR, MODEL 001 MELMEDTRONICS, INC. DAVID W HOLMES
K070598 03/02/2007 MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE MEMOMETAL TECHNOLOGIES GILLES AUDIC
K070672 03/12/2007 MASSAGE MATTRESS VM9100RM METEK GMBH STEFAN ZIEGENFUB
K070590 03/01/2007 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K070656 03/09/2007 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K070816 03/26/2007 PERIPHERAL GUIDING SHEATH MICRUS DESIGN TECHNOLOGY, INC. MARIANNE GRUNWALDT, MS, CQE
K070707 03/14/2007 MICRUS MICROCOIL SYSTEM MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K070694 03/13/2007 CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) MIKE MINER MIKE MINER
K070686 03/12/2007 MINI LAP INSTRUMENTS MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K070779 03/21/2007 SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM MISONIX, INC. RONALD MANNA
K070812 03/26/2007 DISPOSABLE LAPAROSCOPIC INSTRUMENT MODERN MEDICAL EQUIPMENT MFG., LTD. ROBERT STILLMAN
K070877 03/29/2007 ENDOCERVICAL ELECTRODE # 2 MODERN MEDICAL EQUIPMENT MFG., LTD. BOB STILLMAN
K070597 03/02/2007 VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST NANOSPHERE, INC SUE KENT
K070804 03/23/2007 VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST NANOSPHERE, INC SUE KENT
K070778 03/21/2007 NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL NEOCOIL BRIAN BROWN
K070622 03/06/2007 NEOGUIDE ENDOSCOPY SYSTEM NEOGUIDE SYSTEMS, INC. JORGE L PORRAS
K070688 03/12/2007 NEXFIX COMPRESSION STAPLE NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K070844 03/27/2007 NILIMEDIX ADI NILIMEDIX LTD. YORAM LEVY
K070857 03/28/2007 NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM NOBEL BIOCARE AB PHUONG NGUYEN SON
K070611 03/05/2007 BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 NOMOS CORP. MARITA BRUST
K070618 03/05/2007 DICOMPACS, MODEL 5 OEHM UND REHBEIN GMBH FRANZISKA GUNTHER
K070835 03/27/2007 OLYMPUS CK-MB REAGENT OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH STEPHANIE G SCHWARTZ
K070708 03/14/2007 OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH STEPHANIE G SCHWARTZ
K070834 03/27/2007 CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) OMEGA MEDICAL IMAGING, INC. JAMES A PRINCEHORN
K070637 03/07/2007 FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES PARAGON VISION SCIENCES WILLIAM E MEYERS
K070699 03/13/2007 AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN PENTRON CERAMICS, INC. MEGAN VERNAK
K070807 03/26/2007 CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES PEPIN MFG., INC. Gary Syring
K070666 03/12/2007 GENESISCS COMPONENT CONCENTRATING SYSTEM PERFUSION PARTNERS & ASSOC. INC. NANCY LORD MD. ESQ
K070623 03/06/2007 PHARMAPAC LUBRICATING JELLY PHARMAPAC LLC TOM OTTO
K070588 03/01/2007 PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K070792 03/22/2007 QLAB QUANTIFICATION PHILIPS ULTRASOUND, INC. LYNN HARMER
K070745 03/19/2007 MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
K070731 03/15/2007 PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K070757 03/20/2007 MICROPROTEIN REAGENT SET POINTE SCIENTIFIC, INC. RON JAMISON
K070715 03/14/2007 NASOPORE EAR Polyganics BV JAN NIEUWENHUIS
K070664 03/09/2007 PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). PROGENY, INC. ALAN KREMA
K071138 03/16/2007 CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM PROSURG, INC. ASHVIN DESAI
K070846 03/28/2007 MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM PROSURG, INC. ASHVIN DESAI
K070737 03/16/2007 XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES PROSURG, INC. ASHVIN DESAI
K070766 03/20/2007 PSI BANDS PSI HEALTH SOLUTIONS, INC. ROMY TAORMINA
K070594 03/02/2007 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
K070862 03/28/2007 POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) PURTECH CLEANROOM PRODUCTS CO., LTD. KATHY LIU
K070805 03/23/2007 ULTRAWAVE II EX 1320 QUANTA SYSTEM, S.P.A. JONATHAN S KAHAN
K070776 03/21/2007 SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR QUANTEL MEDICAL GEORGE MYERS
K070747 03/19/2007 QUICK VUE RSV TEST, MODELS 20193, 20199 QUIDEL CORP. JENNIFER HANKARD
K070739 03/16/2007 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 RENAL SOLUTIONS INC. DAVID J VANELLA
K070746 03/19/2007 RESTRAXX DATA CENTRE, MODEL R10 RESMED LTD. DAVID D'CRUZ
K070711 03/14/2007 INCIRCLE BI-POLAR RF ABLATION SYSTEM RFA MEDICAL, INC. NANCY LINCE
K070878 03/29/2007 DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 RG MEDICAL DIAGNOSTICS RONALD G LE TOURNEAU
K070788 03/22/2007 ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics KAY TAYLOR
K070585 03/01/2007 ACCU-CHEK PERFORMA SYSTEM ROCHE DIAGNOSTICS CORP. Scott Thiel
K070709 03/14/2007 ROCHE ELECSYS PTH TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY TAYLOR
K070670 03/12/2007 EYETRACKER/IDEAS S.A. INSTRUMENTATION DIFRA GUIDO PAGNACCO
K070761 03/20/2007 SANATMETAL NAILS AND PINS SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. DONALD GUTHNER
K070881 03/30/2007 LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 SAPI MED S.P.A E.J. Smith
K070683 03/12/2007 MIRAGE CEDARS OPTION SEGAMI CORPORATION PHILIPPE BRIANDET
K070645 03/08/2007 SERADYN QMS TOPIRAMATE SERADYN INC. JACK ROGERS
K070596 03/02/2007 TOPICAL APPLICATOR SHARN, INC. PAUL DRYDEN
K070791 03/22/2007 PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K070852 03/28/2007 VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR SHIJIAZHANG HONGXIANG PLASTIC PRODUCTS CO., LTD. KATHY LIU
K070639 03/07/2007 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
K070629 03/07/2007 FLEX AND LOOP COIL SET 1.5 T SIEMENS MEDICAL SOLUTIONS HELMUT NEUMANN
K070727 03/15/2007 ADVIA CHEMISTRY ENZYMATIC CREATININE_2 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS PHILIP LIU
K070799 03/23/2007 MODULARIS VARIOSTAR SIEMENS MEDICAL SOLUTIONS USA INC. KIM RENDON
K070665 03/12/2007 LITHOSKOP SIEMENS MEDICAL SOLUTIONS USA, INC. KIM RENDON
K070793 03/22/2007 SBI DISTAL RADIUS VOLAR PLATING SYSTEM SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K070756 03/20/2007 SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM SMITH & NEPHEW, INC. NICHOLAS TABRIZI
K070732 03/15/2007 BCI AUTOCON 3304 DIGITAL PULSE OXIMETER SMITHS MEDICAL PM, INC. DONALD ALEXANDER
K070783 03/21/2007 SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR SOPRO STEVE SALESKY
K070845 03/27/2007 SOUNMED COLOPOSCOPE COLPO-99/99PLUS SOUNMED, INC. RUBEN OLIVARES
K070841 03/27/2007 ENDOSSEOUS DENTAL IMPLANT SYSTEM SOUTHERN IMPLANTS, INC. GRETA M HOLS
K070634 03/07/2007 SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 SOYEE PRODUCT, INC. STEPHEN T MLCOCH
K070649 03/08/2007 SMS GLUCOSE CONTROL, MODEL 2120061 SPECTRUM MEDICAL SUPPLY, INC. JOHN C GORMLEY
K070676 03/12/2007 KOREBALANCE (KINESTHETIC ABILITY TRAINER) SPORTKAT, LLC DAMON R LAWSON
K070595 03/02/2007 SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR SPSMEDICAL SUPPLY CORP. GARY SOCOLA
K070743 03/16/2007 Z6 STIMULATOR ST CARDIO TECHNOLOGIES, LLC BILL ABBOUD
K070884 03/30/2007 POD B-SCAN STARFISH PRODUCT ENGINEERING INC. DAYRL WISDAHL
K070871 03/29/2007 STARION UNIVERSAL POWER SUPPLY STARION INSTRUMENTS BRIAN GRIGSBY
K070859 03/28/2007 REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS STERILMED, INC. CAROLINE BUTTERFIELD
K070895 03/30/2007 VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK STERIS Corporation JOHN SCOVILLE
K070769 03/20/2007 VHP 136 TRAY STERIS Corporation PATRICK MCCULLAGH
K070765 03/20/2007 VIS-U-ALL II SELF SEAL POUCH STERIS Corporation PATRICK MCCULLAGH
K070876 03/29/2007 STRYKER TWIST DRILLS STRYKER CRANIOMAXILLOFACIAL TENNILLE FOLK
K070882 03/30/2007 STRYKER PEEK TWINLOOP TAC Stryker Endoscopy JEFF SEMONE
K070758 03/20/2007 STRYKER PEEK ZIP SUTURE ANCHOR Stryker Endoscopy ERICA A WALTERS
K070631 03/07/2007 DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM STRYKER SPINE SIMONA VOIC
K070842 03/27/2007 ULCELOOCIN ORAL ULCER PATCH SUNSHINE INTERNATIONAL GROUP, INC. LIPING HE
K070750 03/19/2007 247 BP DEVICE SUNTECH MEDICAL, INC. CHUCK SETZER
K070712 03/14/2007 MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM SURGICAL INNOVATIONS GROUP PLC STUART MORAN
K070782 03/21/2007 WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F SURVIVAIR RESPIRATORS, LLC RICHARD O WOOD
K070678 03/12/2007 DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST SWISSRAY INTERNATIONAL, INC. JOHN MONAHAN
K070843 03/27/2007 SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K070713 03/14/2007 IMPLANT LOCATION SOFTWARE-T TACTILE TECHNOLOGIES, LTD. URIEL WEINSTEIN
K070641 03/08/2007 ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 TaiDoc Technology Corporation ERICA LI
K070673 03/12/2007 FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE Teleflex Medical, Inc. ELIZABETH LANDON
K070894 03/30/2007 TEPHAFLEX SURGICAL MESH TEPHA, INC. MARY P LEGRAW
K070839 03/27/2007 MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY COURTNEY
K070638 03/07/2007 THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC DALE DAVISON
K070786 03/22/2007 X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT THEKEN SPINE LLC DALE DAVISON
K070824 03/26/2007 CREATININE (ENZYMATIC) THERMO FISHER SCIENTIFIC OY PAIVI SORMUNEN
K070599 03/02/2007 CUSTOMIZED SOUND THERAPY (CST) TINNITUS OTOSOUND PRODUCTS, LLC GERALDINE CREAN
K070818 03/26/2007 MEDILOGAR4, MEDILOGAR12 TOM MEDICAL ENTWICKLUNGS GMBH THOMAS HASIBA
K070612 03/05/2007 TOP-RANK ADHESIVE ELECTRODE TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. UWE DEGENHARDT
K070787 03/22/2007 LATITUDE ELBOW PROTHESIS TORNIER Mireille Lemery
K070589 03/01/2007 C! TRANSPHOTON CORPORATION BRANT WIGGER
K070870 03/29/2007 SKIN CARE LIGHT TRANSVERSE INDUSTRIES CO. HO K LIANG
K070674 03/12/2007 AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR TRUDELL MEDICAL INTL. JOHN STRAATMAN
K070685 03/12/2007 KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 TYCO HEALTHCARE PAUL W EVANS
K070653 03/09/2007 KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 TYCO HEALTHCARE PAUL W EVANS
K070591 03/01/2007 REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH UNION DENTAL S.A./UNIDESA.ODI JOSE LUIS RODRIGUEZ
K070614 03/05/2007 CORSCREEN VIASYS HEALTHCARE GMBH DETLEF GROTHEER
K070759 03/20/2007 POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM VIDACARE CORPORATION GRACE HOLLAND
K070661 03/09/2007 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS VITALCOR, INC. DANIEL KAMM
K070723 03/15/2007 FUTURABOND DC/SINGLE DOSE VOCO GMBH THORSTEN GERKENSMEIER
K070705 03/14/2007 MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 VYGON CORP. COURTNEY SMITH
K070644 03/08/2007 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. GORE & ASSOCIATES, INC. BARBARA L SMITH
K070770 03/20/2007 GORE BALLOON SHEATH W. L. GORE & ASSOCIATES, INC. ALAN CURTIS
K070889 03/30/2007 AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 WALLAC OY GUNNEL LAAKSONEN
K070772 03/21/2007 PRESSX ZR WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K070785 03/21/2007 DYNASTY ACETABULAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K070592 03/02/2007 SMALL BONE WEDGE WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K070619 03/05/2007 POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING WRP ASIA PACIFIC SDN. BHD. KIRK PENNER
K070655 03/09/2007 WU'S POWERED WHEELCHAIR, MAMBO 36 WU'S TECH CO., LTD. JEN KE-MIN
K070580 03/01/2007 NASOPHARYNGOSCOPE, BRONCHOSCOPE XION GMBH ALEXANDER KLIEM
K070578 03/01/2007 CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER ZEN STRONG MEDICAL TECHNOLOGY CO., LTD CHENG ROEI-SHENG
K070677 03/12/2007 COLORISE ZHERMACK S.P.A. GERALD W SHIPPS
K070700 03/13/2007 FREEALGIN ZHERMACK S.P.A. GERALD W SHIPPS
K070754 03/19/2007 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 ZIMMER TRABECULAR METAL TECHNOLOGY JENNIFER P HARAKAL
K070695 03/13/2007 ZIMMER PATELLOFEMORAL JOINT PROSTHESIS ZIMMER, INC. DALENE BINKLEY


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