BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517962553·Brigade Lateral Trial, 13x34x32mm 10°

    SUCTION IRRIGATOR

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

    MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    SET SCREW, TI GAMMA3® Ø8X17.5MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·January 4, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Malfunction ·UNKNOWN MANUFACTURING FACILITY·Product code FKX·November 19, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017