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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CITRELOCK® DUO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 12, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·April 13, 2015

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    MYOSURE HYSTEROSCOPE TISSUE REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code HIH·August 24, 2011

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 18, 2013

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·July 12, 2016

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025