BEUDAMED
    11 results · 18ms · 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.

    SKIN SAVER(TM) TUBING HOLDER, MODEL 467

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981081188·Cannulated Tap 7.0mm, Modular (for 7.5mm Screw)

    POWERHEART CARDIAC RHYTHM MODULE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEMOMETAL INTRA-MEDULLARY BONE FASTENER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIAC SURGERY PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DWF·May 13, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 11, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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