FDA 510(k) Applications Received During April, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K100908 04/01/2010 UNICEM HM 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K101216 04/30/2010 AUDIT MICROCV PROTEIN LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K101011 04/12/2010 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL ABBOTT VASCULAR INC. KAY SETZER
K101116 04/21/2010 HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH ABBOTT VASCULAR-CARDIAC THERAPIES KAY SETZER
K101038 04/14/2010 RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER ACCELETRONICS DIGITAL IMAGING, LLC. STEVE SCHWARZ
K101150 04/23/2010 PICC WAND PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K101042 04/14/2010 BLADEVIEW ACCOGENT LLC TRISTAN TICE
K101170 04/26/2010 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM ACUTE INNOVATIONS LLC MARIAH KNIGHT
K100945 04/06/2010 FUSE PLIF CAFE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K101114 04/21/2010 ADVANCIS ACTIVON TUBE Advancis Medical Toni Miller
K101034 04/14/2010 NIOX MINO MODEL 09-1000 AEROCRINE AB JOHANNA KARLING
K101154 04/23/2010 CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L AIRSEP CORP. PETER WEISENBORN
K101006 04/12/2010 WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 ALCON RESEARCH, LTD. MICHAEL BUENGER
K101206 04/30/2010 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, LLC MICHAEL LARSON
K100956 04/07/2010 SPONDY SPINAL FIXATION SYSTEM ALLURE SPINE L.L.C. JULIA ELLER
K101147 04/23/2010 MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM ALMA LASERS, INC. TATIANA EPSTEIN
K101010 04/12/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 ANDON HEALTH CO.,LTD LIU YI
K100940 04/05/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 ANDON HEALTH CO.,LTD LIU YI
K101017 04/12/2010 ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS ANGIODYNAMICS, INC. S. MICHAEL SHARP
K100954 04/07/2010 ADAPT, MODEL AX-03SN APELIOTUS VISION SCIENCE, INC JOHN G EDWARDS
K101204 04/30/2010 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K100959 04/07/2010 SPECIMEN RETRIEVAL SYSTEM APPLIED MEDICAL RESOURCES FRANS VANDENBROEK
K100926 04/05/2010 ARROWHEAD FIXATION DEVICE ARROW PRODUCTS, INC. SCOTT R ROMAN
K101184 04/28/2010 TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K100925 04/02/2010 ASCENSION ANKLE FUSION NAIL SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K100909 04/01/2010 REPROCESSED COMPRESSION SLEEVES ASCENT HEALTHCARE SOLUTIONS RAMONA KULIK
K101087 04/19/2010 REPROCESSED RESTEP COMPRESSION SLEEVES ASCENT HEATLHCARE SOLUTIONS AMANDA BOBCOCK
K101005 04/12/2010 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT ASTRA TECH AB LINDA SCHULZ
K101004 04/12/2010 ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K101174 04/27/2010 ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 ATRICURE, INC. JAMES LUCKY
K100919 04/02/2010 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 B-K MEDICAL APS RANDI HAUERBERG
K101111 04/21/2010 HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 BARRX MEDICAL INC VIORICA FILIMON
K100958 04/07/2010 MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES BAXANO, INC. EDWARD J SINCLAIR
K101117 04/21/2010 LEV-OR DILATION CATHETER OTW BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K101122 04/21/2010 BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS BENZ RESEARCH AND DEVELOPMENT CORP. GIOVANNY ESPINOSA
K101105 04/20/2010 POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K101102 04/20/2010 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K101106 04/20/2010 POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K101103 04/20/2010 POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K100985 04/09/2010 BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K100917 04/02/2010 FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K101063 04/16/2010 SLEEVE WITH ZIPLOOP FIXATION DEVICES BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K101086 04/19/2010 TAPERLOC COMPLETE BIOMET, INC. GARY BAKER
K101030 04/13/2010 MODIFICATION TO HBS HEADLESS BONE SCREW BIOPRO, INC. DAVID MRAK
K101138 04/22/2010 SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 BIOSENSE WEBSTER, INC. MELISSA C SCHULTZ, RAC, MMS
K101078 04/19/2010 BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. MICHAEL MATHUR
K100929 04/05/2010 UNIMOM ALLEGRO BLUE EGG CO HONG J HYUN
K101123 04/22/2010 NEXFIN MODEL 2 BMEYE B.V. WILLIAM F GREENROSE
K101064 04/16/2010 BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P BREDENT GMBH & CO.KG ANDREA PECSI
K100913 04/01/2010 IQVITALS AND IQVITALS SYSTEM BRENTWOOD MEDICAL TECHNOLOGY CORP. GREG HOLLAND
K101097 04/20/2010 CALGAESEAL MODEL: CAS BZ MEDICAL INC BYRON ZAHLER
K101016 04/12/2010 ANS SYSTEM CAIRD TECHNOLOGY JAMES H BROWN
K101169 04/26/2010 DESARA MESH MODEL: CAL-DS01 CALDERA MEDICAL, INC. VICKI GAIL
K100947 04/06/2010 FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 CALIBRA MEDICAL, INC. RICHARD J MEADER
K101118 04/21/2010 ACTIVON TULLE CALIDAD SOLUTIONS, INC. JOHN BILLINGS
K100994 04/09/2010 PRELOADED TISSUE MARKER DEVICE CARBON MEDICAL TECHNOLOGIES, INC. TINA M WITTCHOW
K101018 04/13/2010 CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 CARDICA, INC. MATTHEW E CHROUST
K101032 04/14/2010 CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX CARDO MEDICAL, INC MICHAEL KVITNITSKY
K101182 04/27/2010 IOLMASTER 500 CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K101194 04/28/2010 NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 CARTICEPT MEDICAL INC Tanya Eberle
K100960 04/07/2010 WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS CEFLA DENTAL GROUP CYNTHIA J.M. NOLTE, PH.D.
K101043 04/14/2010 ECT DIGITAL THERMOMETER CHANGSHAN ESTAR ELECTRONICS CO., LTD. JACOB CHANG
K101148 04/23/2010 WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC STEVEN J BERKE
K101198 04/29/2010 CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K COMPUTERIZED SCREENING, INC. SAM KUMAR
K101100 04/20/2010 CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 CONMED LINVATEC JOHN CUSACK
K100933 04/05/2010 CONSENSUS CS2 PLUS ACETABULAR INSERT Consensus Orthopedics, Inc LUKE ROSE
K101127 04/22/2010 PATIENT MONITOR, MODEL PM50 CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K100974 04/08/2010 SPECTRUM TURBO-JECT PICC SET COOK INCORPORATED SUSANNE GALIN
K101126 04/22/2010 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS CORE ESSENCE ORTHOPAEDICS, INC. JEFF MILLER
K101131 04/22/2010 FIDUCIAL MARKERS COSMAN MEDICAL, INC. LOUIS FALCONE
K101151 04/23/2010 REGENT ANTERIOR CERVICAL PLATE CUSTOM SPINE SAAD ATTIYAH
K101140 04/22/2010 DENTLIGHT ORAL EXAM LIGHT KIT DENTLIGHT INC. RICHARD LIU
K101215 04/30/2010 NUANCE DISCUS DENTAL, LLC WINKIE WONG
K101133 04/22/2010 SENSOMETRICS SOFTWARE DPCOM AS CONSTANCE BUNDY
K100941 04/05/2010 INFINITY MCABLE - MAINSTREAM CO2 DRAEGER MEDICAL AG & CO. KG ULRICH SCHROEDER
K101094 04/20/2010 CLEARJET EASYGLIDE LTD. PAUL DRYDEN
K101080 04/19/2010 NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN HARALD JUNG
K100988 04/09/2010 HUMAPEN LUXURA HD ELI LILLY AND COMPANY STEVEN T JOHNSON PE, MBA
K100902 04/01/2010 AEDIS(TM) EMBED TECHNOLOGY LLC HOWARD STAMER
K101037 04/14/2010 EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 EPS BIO TECHNOLOGY CORP. YC LEI
K101108 04/20/2010 ERBE ESU MODEL VIO 100 C WITH ACCESSORIES ERBE USA, INC. JOHN TARTAL
K100931 04/05/2010 MYLABTWICE, MODEL 6200 ESAOTE, S.P.A. Allison Scott
K100936 04/05/2010 GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, INC. SUSAN LIN
K101128 04/22/2010 BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 FILLIGENT LIMITED IAN GORDON
K101152 04/23/2010 NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 FOCUS MEDICAL, LLC. JOHN LEE
K101166 04/26/2010 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ GE HEALTHCARE BRYAN BEHN
K101149 04/23/2010 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS BRYAN BEHN
K101200 04/29/2010 PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE GIVEN IMAGING LTD. Tim Thomas
K100971 04/08/2010 ATEK SURGICAL GOWNS HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD Glen Feye
K101002 04/12/2010 A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K101142 04/22/2010 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K101143 04/22/2010 HEARTWAY POWER MOBILITY SCOOTER, S11 HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K100963 04/07/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT CHU XIAOAN
K100964 04/07/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT CHU XIAOAN
K101096 04/20/2010 HT III SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K100943 04/06/2010 INVADER FACTOR II HOLOGIC, INC. RANDALL COVILL
K100980 04/08/2010 INVADER FACTOR V HOLOGIC, INC. RANDALL J COVILL
K100987 04/09/2010 INVADER MTHFR 677 HOLOGIC, INC. RANDALL COVILL
K101132 04/22/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) HONG DI PLASTIC PRODUCTS CO., LTD. JIE LIU
K101137 04/22/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVE HONGZE PLASTIC TECHNOLOGY CO., LTD KATHY LIU
K101135 04/22/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) HONGZE PLASTIC TECHNOLOGY CO., LTD KATHY LIU
K101047 04/14/2010 PTA-DUO PTA BALLOON CATHETER HOTSPUR TECHNOLOGIES ERIC P ANKERUD
K101072 04/19/2010 TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K101056 04/15/2010 VARIAX ELBOW SYSTEM HOWMEDICA OSTEONICS CORP. MELISSA MATARESE
K101029 04/13/2010 KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH HUGE DENTAL MATERIAL CO., LTD. JING LI
K100915 04/01/2010 INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 HUTCHINSON TECHNOLOGY, INC. COLIN MCGRAW
K100937 04/05/2010 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE i-SENS, Inc. HYUN OH
K100989 04/09/2010 ZURA TEE SYSTEM WITH CLARITEE PROBE IMACOR INC. RICHARD LANZILLOTTO
K101052 04/15/2010 OMNI III PATIENT MONITOR INFINIUM MEDICAL JOHN OBRIEN
DEN100002 04/08/2010 INFRASCANNER, MODEL 1000 INFRASCAN, INC. STEVEN B DATLOF
K100992 04/09/2010 NEURALMAS INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") SUSAN D GOLDSTEIN-FALK
K101178 04/27/2010 MODIFICATION TO INTEL HEALTH GUIDE PHS6000 INTEL CORP. MAUREEN GLYNN
K100991 04/09/2010 IMC SURGICAL DRAPE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K101077 04/19/2010 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 INTUITIVE SURGICAL, INC. KAREN UYESUGI
K100921 04/02/2010 ADMIRAL XTREME PTA BALLOON DILATATION CATHETER INVATEC S.P.A. JOHN CLAY
K101185 04/28/2010 NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY IRIS MOLECULAR DIAGNOSTICS ROBERT KLEM
K100975 04/09/2010 NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K100979 04/08/2010 NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K100978 04/08/2010 POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K100977 04/08/2010 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K101207 04/30/2010 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S KEVIN A THOMAS
K101084 04/19/2010 CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K101022 04/13/2010 PULMOTRACK 5050 WHOLTER, MODEL 5050 KARMELSONIX YORAM LEVY
K101201 04/29/2010 STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, KAT IMPLANTS, LLC VITALI BONDAR
K101175 04/27/2010 KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER KFX MEDICAL GAYLE HIROTA
K100912 04/01/2010 DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K101049 04/14/2010 WART FREEZE KONINKLIJKE UTERMOHLEN NV SHIRLEY FURESZ
K101136 04/22/2010 FISIO CHAMBER SPACE KOO(SHANGHAI)INDUSTRIES CO., LTD. PAUL DRYDEN
K101158 04/26/2010 LIC INSTRUMENT PROCESSING SYSTEM LANGFORD IC SYSTEMS, INC. TERRY LANGFORD
K100935 04/05/2010 LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K101190 04/28/2010 LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC LED INTELLECTUAL PROPERTIES, LLC ROBERT T WAGNER
K101098 04/20/2010 REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 LIL DRUG STORE PRODUCTS, INC. PATRICIA MILLER
K101195 04/29/2010 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. BERNICE LIN
K101014 04/12/2010 BOND BONE M.I.S. IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K101157 04/26/2010 E-BASIC SINGLE BREAST PUMP MAPA GMBH SHEILA W PICKERING
K101153 04/23/2010 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K101199 04/29/2010 GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, MAQUET CRITICAL CARE AB WHITNEY TORNING
K101031 04/13/2010 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 MASIMO CORPORATION MARGUERITE THOMLINSON
K101214 04/30/2010 GUARDIAN CONNECTION MAULIN MEDICAL LLC SARA OWENS
K100927 04/05/2010 SURGIAID MAXIGEN BIOTECH, INC. JENNIFER REICH
K101088 04/19/2010 EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT MEDICA CORP. Photios Makris
K101090 04/19/2010 EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS MEDICA CORP. Photios Makris
K101089 04/19/2010 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR MEDICA CORP. Photios Makris
K101134 04/22/2010 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 MEDICEL AG JOHN COGGAN
K101177 04/27/2010 APEXNRG RIDER MEDICNRG LTD. George Hattub
K100916 04/02/2010 MEDICON MOGEN CLAMP MEDICON, E.G. JOACHIM SCHMID
K101145 04/23/2010 SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 MEDIPURPOSE PTE. LTD. JULIE STEPHENS
K101092 04/20/2010 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 MEDIVANCE, INC. LYNNE ARONSON
K101070 04/16/2010 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL DAPHNEY GERMAIN
K100951 04/06/2010 MEDTOX BUPRENORPHINE TEST MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K101212 04/30/2010 MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R MEDTRONIC INC. BECKY HANNACK
K101139 04/22/2010 PROSTIVA RF THERAPY MODEL 8929 HAND PIECE MEDTRONIC INC. THOMAS REICHEL
K101186 04/28/2010 AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG MEDTRONIC PERFUSION SYSTEMS CARALEE WALTON
K101168 04/26/2010 LEGEND POWER ADAPTER MODEL: 6475000 MEDTRONIC SOFAMOR DANEK THERESA LEISTER
K101074 04/19/2010 MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SARAH FAIRFIELD
K100967 04/08/2010 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K100976 04/08/2010 T2 XVBR 1.5 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. THERESA LEISTER
K100953 04/06/2010 MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K101013 04/12/2010 MODIFICATION TO SCINTRON IV MIE GMBH NORMAN VON HOLLEN
K100905 04/01/2010 HYDROFIX SURGICAL SHEET MIMEDX GROUP, INC LOUISE FOCHT
K101101 04/20/2010 MINI-TONG MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K101163 04/26/2010 BIOGEL ORTHOPRO INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE USA ANGELA BUNN
K101115 04/21/2010 ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 MORTARA INSTRUMENT, INC CHARLES MORREALE
K100934 04/05/2010 AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES, DAVID WISE
K100948 04/06/2010 HYPO CLENZ WOUND WASH MODEL 100 PPM NEVOA LIFE SCIENCES, LLC S. DAVID PIPER, PE
K100944 04/06/2010 CLAVICLE LOCKING PLATE SYSTEM NEWCLIP TECHNICS J.D. WEBB
K101053 04/15/2010 OLYMPUS CF TYPE Y0023-L, Y0023I OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER
K101059 04/15/2010 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE OMEGA LABORATORIES, INC. ROBERT J BARD
K101171 04/26/2010 ORTHOVITA PEEK SPACER ORTHOVITA, INC. CATHERINE V MOFFA
K100957 04/07/2010 DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION PACIFIC CONSOLIDATED INDUSTRIES, LLC GARY CLARK
K101083 04/19/2010 DSS STABILIZATION SYSTEM PARADIGM SPINE LLC MICHELLE MCDONOUGH
K101044 04/14/2010 RETRIEVE IMPLANT CEMENT PARKELL, INC. DANIEL R SCHECHTER
K100999 04/12/2010 IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 PHADIA AB MARTIN MANN
K101067 04/16/2010 SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 PHILIPS MEDICAL SYSTEMS PENG CUI
K100939 04/05/2010 INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K101193 04/28/2010 PMC LAPAROSCOPIC INSTRUMENTS PMC MEDICAL GMBH ANDREA PECSI
K101218 04/30/2010 PATCHASSIST POLYTOUCH MEDICAL LTD LEO BASTA
K100932 04/05/2010 INCLUSIVE MINI IMPLANT PRISMATIK DENTALCRAFT, INC. KEITH ALLRED
K100993 04/09/2010 INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS PRISMATIK DENTALCRAFT, INC. KEITH ALLRED
K101076 04/19/2010 PROWESS PANTHER PROARC, MODEL VERSION 5.0 PROWESS, INC. RACHEL SCARANO
K100918 04/02/2010 VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 PURICORE INC. DENNIS MAHONEY
K101068 04/16/2010 ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS RADIANT EXPRESS LLC RYAN CHIOU
K101189 04/28/2010 REAVILLMED PRESSURE MONITORING SYSTEM AND PICC REAVILLMED MICHELE H VOVOLKA
K101172 04/26/2010 RDT3 HANDPIECE HEAD MODEL RDT3 REDENT NOVA LTD JONATHAN S KAHAN
K101217 04/30/2010 MAC-MOBILE AQUATIC CHAIR REHAMED INTL. LLC. JOHN CADEN
K101112 04/21/2010 RELIANCE SPINAL SCREW SYSTEM RELIANCE MEDICAL SYSTEMS BRET BARRY
K101130 04/22/2010 BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK RESPIRONICS, INC. ZITA A YURKO
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