BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    INSTRUMENT SCOPE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sunmed Haemostatic Valves

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECEPT TM CARBENICILLIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·October 18, 2024

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVY·February 9, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 23, 2014

    1.5MM SYSTEM 4 HOLE LONG STRAIGHT PLATE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·December 12, 2017

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025