BEUDAMED
    16 results · 19ms · 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.

    ABTOX PLAZLYTE PROCESS MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Colonic Irrigation Kit

    FDA UDI
    CLEARWATER COLON HYDROTHERAPY, INC.·B4249234420·Straight Style Large Speculum Kit ~ 1/4 inflow ...

    EXTRA LARGE BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    XOFT AXXENT CERVICAL APPLICATORS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·March 20, 2026

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 16, 2026

    ARCHITECT TSH

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·April 15, 2026

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·January 22, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·December 13, 2010

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 5, 2025

    ALINITY I TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 15, 2025

    ARCHITECT TSH

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·September 5, 2025

    ARCHITECT TSH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JLW·November 19, 2024

    THERMA CARE

    FDA Adverse Event
    Injury ·PROCTER & GAMBLE PAPER PRODUCT CO·Product code IMD·March 6, 2002

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015