BEUDAMED
    8 results · 23ms · 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.

    ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131256126·NERA PRO, BTE 13 WL 85 TC

    NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MENTOR OBTAPE TRANS-OBTURATOR TAPE

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 21, 2008

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020