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

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    BIPAP SYNCHRONY HC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517677358·Monolith Endcap, 15x13mm Lord 10° Ø12

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517235619·Armada Ti 3CO Rectractor, 30mm Spoon

    Surefil one Self-adhesive Composite Hybrid

    FDA 510(k)
    FDA Class 2 ·Dental

    SPRYTIE, MODELS ST001, ST002 AND ST003

    FDA 510(k)
    FDA Class 2 ·Dental

    WALLSTENT RP ENDOPROSTHESIS

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

    SC+ QBL SOFTWARE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code LWH·July 29, 2025

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD / HUNTINGTON·Product code MFK·March 4, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    CONCERTO II CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011

    WALLSTENT? RP ENDOPROSTHESIS

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

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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