BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    Nuheara IQbuds 2 PRO Hearing Aid

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111317729·TISSUE FCP 1X2, 6" DEL

    MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUANTIM 16 AUTOCLAVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEEDLE CLIPPING DEVICE SAFE CLIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·July 6, 2020

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·November 7, 2008

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 23, 2011

    BARD SOFT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 5, 2013

    BD NEEDLE CLIPPING DEVICE SAFE CLIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·September 23, 2021

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018