BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    Arthrex Patella SuturePlates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCELERATOR APS

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JQP·November 7, 2017

    HL888

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARELINK

    FDA Adverse Event
    Malfunction ·PLEXUS MANUFACTURING SDN. BHD.·Product code NVZ·August 11, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 23, 2014

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·AVENT S. DE R.L. DE C.V.·Product code HEB·July 3, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 31, 2023

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 31, 2023

    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