BEUDAMED
    10 results · 22ms · 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.

    GenBody COVID-19 Ag Home Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    POLAR CATH PERIPHERAL DILATATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRI Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 30, 2024

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    ENDURANT

    FDA Adverse Event
    Death ·MEDTRONIC IREALAND·Product code MIH·July 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 25, 2015

    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·December 26, 2018