BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    Everyway Analog OTC TENS, model N103A/N302

    FDA 510(k)
    FDA Class 2 ·Neurology

    BODY CLOCK TENS N' TONE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HYDROTHERMABLATOR PROCEDURE SET

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MNB·October 17, 2008

    CAPSURE EPI

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DTB·August 11, 2011

    TOTAL ASR ACET IMP SIZE 60

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025