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

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    CD HORIZON Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Low Profile Acetabular Reamer 57

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057602·

    LEFORTE SYSTEM BONE PLATE & SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    PICSI SPERM SELECTION DEVICE

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

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·October 6, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 7, 2013

    PUMP IN STYLE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 22, 2011

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014