BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

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

    BELLEGLASS HP OPAQUE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTZ·April 29, 2013

    M2A MAGNUM TAPER ADAPTER 42-50MM HEAD SIZE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 10, 2011

    CRYSTALENS

    FDA Adverse Event
    Injury ·EYEONICS, INC.·Product code HQL·July 28, 2008

    INFOV.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021

    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