BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    VIA-GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MCable-Mainstream CO2

    FDA UDI
    Drägerwerk AG & Co. KGaA·04048675225140·

    Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNGO TRUED

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIOSAVE

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·April 17, 2014

    UNKNOWN 34MM NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2015

    CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    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