BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074229256·PLATE 6861277 77.5MM FSP ANTERIOR CRV

    ConvertX Nephroureteral Stent System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING

    FDA 510(k)
    FDA Class 2 ·Dental

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·October 1, 2010

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 2, 2012

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012