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

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    AMSafe Pre-Filled Normal Saline Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020336·FPS 3.5mm x 22mm Standard Screw

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074384·FPS 3.5 x 22mm Screw Sterile Qty 2

    SOMATOM P30 CT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PATHASSIST LIGHT SEEKER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    X-FLOW PROSTATECTOMY CATHETER

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code EZL·February 27, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·October 27, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

    FDA Enforcement
    Class II ·Ongoing·MICROVENTION INC.·February 19, 2025

    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code QCA·December 11, 2024

    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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