BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    SILCLAMPS DEGANIA SILICONE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOBLATE®

    FDA UDI
    MEDTRONIC, INC.·00613994334558·ABLATION PEN 4920501 W/PACING SENSING EN

    Sonoma

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087333·Sonoma Sterilization Tray

    Pounce Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHAMP CHAMP TRANSIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 12, 2010

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 15, 2012

    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023