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

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    DISPOS. ENTERIC FEEDING TUBES W/SAFE-T

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    THD N-ANO ANOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ECHELON Synergy V10.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLUME PEN

    FDA Adverse Event
    Injury ·BUFFALO FILTER·Product code GEI·May 21, 2014

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·November 15, 2012

    LCS TEX ROT PLAT TIB PLAT STD+

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 8, 2010

    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 20, 2019

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021