BEUDAMED
    13 results · 18ms · 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 ×

    ACTICOAT PRIMARY ANTIMICROBIAL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157187·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157163·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024157170·

    COLONIC SPLINTING OVERTUBE, MODEL 00711145

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

    FDA 510(k)
    FDA Class 2 ·Dental

    ASAHI APS DIALYZERS

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·March 1, 2013

    INTEGRATED APD SET W/CASSETTE3 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 15, 2011

    CONSULTA CRT-P

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·August 8, 2014

    DELTA CERAMIC FEM HD 36/+3MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·June 27, 2023

    BIOLOX DELTA MODULAR CERAMIC FEM HD 36/+3MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 19, 2022

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017