BEUDAMED
    13 results · 29ms · 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 ×

    Surgi Max Ultra

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

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691108·Titanium Angulated Multi-Unit Abutment Int. Hex...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776369224·Van Buren Catheter Guide

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·November 19, 2001

    SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARI HYDRATE G

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    Widex

    FDA UDI
    Widex A/S·05706069897845·WIDEX EVOKE E-XP (Dark brown ) 30, Telecoil, RC...

    MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·October 14, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·June 14, 2013

    CAPIOX RX OXYGENATOR W/HS RESERVOIR

    FDA Adverse Event
    Other ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·June 20, 2011

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020