BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131556·TiBase SS RN SYN .3G E

    VIVATHERM THEMPERATURE MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GLIDECROSS SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLDVAC SMOKE EVACUATION PENCIL WITH ROCKER SWITCH

    FDA Adverse Event
    Injury ·CONMED ELECTROSURGERY·Product code GEI·October 1, 2014

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCI·May 17, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015