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

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    MELODY, Remote Control System for Ultrasound Probe

    FDA 510(k)
    FDA Class 2 ·Radiology

    FETCH 2 ASPIRATION CATHETER MODEL 109400-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROSELECTRON V3, MODEL 106.990

    FDA 510(k)
    FDA Class 2 ·Radiology

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    FDA Enforcement
    Class II ·Terminated·Summit Medical, Inc.·December 23, 2015

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·October 10, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·June 11, 2013

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 13, 2011

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    FDA Recall
    Terminated ·Summit Medical, Inc.·Product code LRD·September 3, 2015