BEUDAMED
    9 results · 32ms · 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.

    CENTRIA CORTISOL RIA TEST SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CANNULAS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TOXO TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·January 13, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 10, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 10, 2010

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018