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

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    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VenSure Balloon Device, VenSure Nav Balloon Device

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

    HMS-DHR-3 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·November 7, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014

    SUNBEAM

    FDA Adverse Event
    Malfunction ·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·August 17, 2011

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·July 9, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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