BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    STERILE FIELD SALINE PRE-FILLED SYRINGE(S)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIS ENGINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER W/ VAMP COMBO

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·July 24, 2008

    LIGASURE PRECISE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 29, 2011

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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