BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    PROPENCIL ESU PENCIL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INTEGRAPH FLASH, MODEL CI 110

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STRYKER NAVIGATION SYSTEM - ENT MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    METRX® SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·March 6, 2025

    DURA-GUARD PERICARDIUM WITH APEX PROCESSING

    FDA Adverse Event
    Injury ·SYNOVIS SURGICAL INNOVATIONS·Product code GXQ·May 3, 2013

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·May 5, 2011

    CAP FOR INJECTOR MEMBRANE M50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015