BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CAMLAB CRANIAL ORTHOSIS HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUART ARTERIAL FILTER, MODEL HBF 140

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 16, 2019

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 18, 2008

    VOYAGER CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·May 9, 2011

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    145-DEG PE 42MM HUM LINER +0

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 21, 2025

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    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