BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    PRESTYL JET INJECTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    SAS BLOOD/SERUM/URINE/URINE HCG

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Fibroid Mapping Reviewer Application (FMRA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    RSP SHOULDER

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code KWS·July 9, 2014

    DURASTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·December 27, 2012

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

    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