BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ABX PENTRA 60 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198741·AK3 Ultra Insert Trial Size 5, 11mm

    Buccal Tubes

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746084096·DB TUBE INCONEL UL 2ND MOL 022 T=0 R=0 2MM

    HELENA FACTOR VII DEFICIENT SUB. PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

    BOOT COVER

    FDA Adverse Event
    Malfunction ·BROADLINE MEDICAL, INC·Product code FXP·February 19, 2013

    SELECT SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·February 15, 2011

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·August 8, 2014

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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