BEUDAMED
    14 results · 20ms · 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.

    SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Arthrx Fracture Plates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPIRA®-C Integrated Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    BD VACUTAINER® PLASTIC SERUM TUBE WITH RED BD HEMOGARD¿CLOSURE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 22, 2022

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code HDD·August 11, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 30, 2013

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/48, CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·January 6, 2020

    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