BEUDAMED
    11 results · 26ms · 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.
    Filters Regulation: Us FDA ×

    OMBRA TABLE TOP COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oticon

    FDA UDI
    Oticon A/S·05707131259288·NERA, KIT 312 WL DIR L H BE

    VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AIRBRUSH LIPOSCULPTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 1, 2014

    VITAGEL 4.5ML

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOBIOLOGICS-MALVERN·Product code LMF·May 29, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

    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