BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    980nm Diode Laser Therapy Device

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

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032153·ET40 MNR, 2.4G NFM PB BR ENCHANT 40

    ELECSYS SHBG CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    :CADD SOLIS HPCA PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·April 12, 2023

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    FLEX ADV.3000ML GEL-VAC

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code GCX·June 26, 2013

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 10, 2025

    BD PHASEAL¿ OPTIMA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·February 19, 2019

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·February 20, 2019

    BD PHASEAL¿ OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·February 11, 2019

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·February 25, 2019

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018