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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    5X2 SATALEC CHIROPODY CASE

    FDA 510(k)

    Zenysis Dual Lumen Acute Dialysis Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741109751·Zenysis DL, 20cm ST Kit

    Power-Trialysis Slim-Cath catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741107245·12Fr Trialysis ST 20cm Kit

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196600·Revision Knee Spiral Reamer- Hudson Short Flute...

    SnoreRx

    FDA 510(k)
    FDA Class 2 ·Dental

    GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

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

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ACCU-CHEK ® SPIRIT COMBO·Product code LZG·June 6, 2014

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 5, 2010

    THE CROSSER SYSTEM

    FDA Adverse Event
    Malfunction ·FLOWCARDIA, INC.·Product code DQY·June 25, 2008

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 28, 2010

    SNORERX

    FDA Adverse Event
    Injury ·APNEA SCIENCES·Product code LRK·May 22, 2017

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·August 6, 2010

    NIM 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·October 21, 2020

    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