BEUDAMED
    9 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.

    SperSort™ Sperm Sorting Chip (IPG02)

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

    NA

    FDA UDI
    Synthes GmbH·10886982167439·LOCKING CALCANEAL PLATE EXTRA LONG-RIGHT

    IMMUNOCARD STAT! FLU A & B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Safety Subcutaneous Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICRO DRILL LONG STRAIGHT ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 2, 2011

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC·Product code MGB·November 18, 2008

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 22, 2013

    SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)

    FDA Adverse Event
    Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code KNS·May 7, 2024

    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