BEUDAMED
    17 results · 27ms · 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.

    Pirouette High Pressure (HP)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    External Fixation

    FDA UDI
    Life Spine, Inc.·00190837023102·Female Post, 1 Hole

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036982·Trial Rasp, No Stop, Assembly, Straight, 6mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037019·Trial Rasp, No Stop, Assembly, Straight, 9mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037002·Trial Rasp, No Stop, Assembly, Straight, 8mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037040·Trial Rasp, No Stop, Assembly, Straight, 12mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037033·Trial Rasp, No Stop, Assembly, Straight, 11mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037026·Trial Rasp, No Stop, Assembly, Straight, 10mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036975·Trial Rasp, No Stop, Assembly, Straight, 5mm

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036999·Trial Rasp, No Stop, Assembly, Straight, 7mm

    COMBITRANS MONITORING SETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OTODYNAMICS OTOPORT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·June 17, 2013

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·July 22, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008

    FIX PIN FLTD 3.2DX150MM 2 PACK

    FDA Adverse Event
    Injury ·ZIMMER CAS·Product code OLO·March 24, 2025

    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