BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OT ULTRA2 METER

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

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 13, 2011

    MAXIMO II CRT-D

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021