BEUDAMED
    24 results · 26ms · 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 ×

    tremoFlo C-100 Airwave Oscillometry System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BINAXNOW COVID-19 SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 27, 2021

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·January 25, 2022

    SLEEP APP

    FDA 510(k)
    FDA Class 2 ·Dental

    TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 22, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 14, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 3, 2023

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 10, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 25, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 11, 2022

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 2, 2025

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·February 5, 2018

    IN00087 CLERMONT FERRAND PH

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

    TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI

    FDA Adverse Event
    Other ·ARTHROCARE CORPORATION·Product code GEI·June 29, 2011

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SUR·Product code GDW·June 7, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 11, 2008

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·October 3, 2012

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 24, 2014