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

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    TS-BONE HIP TOOL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURGICAL DYNAMICS MESH CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HILL-ROM PRIMAVIEW MONITOR SYSTEM

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

    HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTR·April 12, 2013

    AXIALIF SYSTEM

    FDA Adverse Event
    Other ·TRANS1 INC.·Product code JDN·June 20, 2008

    VERITAS COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·April 13, 2011

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022