BEUDAMED
    7 results · 16ms · 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.

    PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MUTARS® femoral stem cemented 160 mm and 200 mm

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOTAL BILIRUBIN REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·February 3, 2013

    54CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·December 20, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020