BEUDAMED
    9 results · 36ms · Sources: EU EUDAMED, US FDA

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    AXXENT SURFACE APPLICATOR, MODEL 710257

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SERUM PROTEIN SUBSTITUTE

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

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 21, 2021

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·April 29, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 24, 2008

    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