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

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    Silverlon Wound Contact, Burn Contact Dressings

    FDA 510(k)
    FDA Unclassified ·Unknown

    PAP-CAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SENTINEL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    S-ROM INSRT M28, 10DEG, 26MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 3, 2008

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·June 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 25, 2011

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018