BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    ENIGMA HI-BASE DENTURE BASE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 22, 2024

    DISPENSA-LUBE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    C-MOR VISUALIZATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 6, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code DQA·January 13, 2011

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

    ALERE HCG CASSETTE

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·May 25, 2023

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024