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

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    ENCORE REVERSE SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481476262·

    MECHANICAL DAILY USE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EASYBELL

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·August 28, 2015

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    ROTABLATOR GUIDE WIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code MCX·May 22, 2008

    V.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KCI USA, INC.·Product code OMP·April 5, 2011

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·September 11, 1997

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·August 28, 2015

    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

    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