BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

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

    RIDIDFIX 2.7MM BTB CROSS PIN KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 18, 2025

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    MAXPLUS CLEAR NEEDLESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·April 3, 2013

    CYCLESURE BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·June 19, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 15, 2011

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 29, 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

    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