BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    STOPCOCK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

    FDA 510(k)
    FDA Class 2 ·Immunology

    REALSEAL SE

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·June 26, 2014

    OPTISENSE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Other ·SOFRADIM PRODUCTION·Product code FTL·November 16, 2012

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024