BEUDAMED
    19 results · 22ms · 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 ×

    CONDUIT Cages; FIBERGRAFT BG Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEALIX TRANSTEND ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705020287·HEALIX TRANSTEND PEEK Anchor with ORTHOCORD PEE...

    RESPIRATORY DELIVERY SYSTEMS, INC.

    FDA registration
    RESPIRATORY DELIVERY SYSTEMS, INC.·1 product·🇺🇸 United States

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KOKOMATE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CELL-DYN RUBY ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 12, 2013

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·August 5, 2025

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·August 5, 2025

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·August 5, 2025

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 12, 2024

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·October 3, 2022

    HEALIXTRANSTEND PEEK1 IMPL SYS

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HWC·December 1, 2017

    HEALIX TRANSTEND PEEK ANC W/OC

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MAI·December 1, 2017

    HEALIXTRANSTEND PEEK1 IMPL SYS

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MAI·December 1, 2017

    HEALIX TRANSTEND PEEK ANC W/OC

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MAI·December 1, 2017

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014