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

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    Electromed SmartVest Airway Clearance System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

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

    ANTHEM Fracture System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    S-ROM SLEEVE PRX ZTT, 16F-LRG

    FDA Adverse Event
    Injury ·DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code MRA·November 5, 2008

    EYE SURGERY STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 13, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

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