BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Immunology

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DEXATIP VENTRICULAR BIPOLAR PACING LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code DTB·August 17, 1995

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2024

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 22, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022