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

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    ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    22G X 0.75 IN. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·October 20, 2017

    MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

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

    AVANTE CURELIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 21, 2018

    POWERED PATIENT ROTATION BED

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code IKZ·April 29, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·May 10, 2011

    PROCEED MULTI-LAYER LAMINATE MESH

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code FTL·July 23, 2008

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023

    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