BEUDAMED
    19 results · 25ms · 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.

    LenSx Laser System (8065000944)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813053560·STERILIZATION POUCH 12 X 17

    Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALIGNRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 13, 2014

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·September 9, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 15, 2013

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026

    BD SYRINGE 10ML S/T BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 6, 2022

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

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