BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196426·AK3 CR Femoral Trials Size 1 - 5 Left Pan

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195139·AK3 CR Femoral Trials Size 1 - 5 Left Pan Insert

    INFX-8000V WITH

    FDA 510(k)
    FDA Class 2 ·Radiology

    D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 1, 2024

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 1, 2022

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

    PLUS SL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS AG·Product code KWY·October 7, 2008

    CLINITEK STATUS +

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIL·June 20, 2013

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FRN·June 29, 2011

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    REZUM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019