BEUDAMED
    12 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 ×

    Threshold™ Pedicular Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131305275·SENSEI PRO, BTE 13 WL 90 AQM TAR

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776397746·Crafoord-Collier Clamp, 9 1/2", curved, delicate

    MEDCARE MECHANICAL WHEELCHAIR, MODELS MC-281S & MC-200S

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HANDHELD PULSE OXIMETER MODEL M800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OXF DOMED LAT TIB TRAY SZ D-UK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 15, 2019

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Death ·ZOLL CIRCULATION, INC·Product code DRM·May 23, 2013

    COMPOSIX MESH E/X

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·July 7, 2011

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017