BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTIMOL

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

    GUIDEMIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·December 19, 2017

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2011

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS INC.·Product code JDN·September 11, 2008

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017