BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH

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

    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP, FORMERLY US SURGICAL·Product code KOG·August 6, 2014

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS OPTICAL CO. LTD.·Product code FDS·October 4, 2005

    ANGIO-SEAL DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·March 23, 2011

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013