BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PS-843262

    FDA UDI
    PATHEN MEDICAL LLC·00850005864639·26GX.75" IV CATHETER PURSAFETY S

    Smith's Catheters

    FDA UDI
    MEDSOURCE INTERNATIONAL LLC·00840155411357·Truesafe Comfort (PUR Catheter), 26G x 0.75"

    GE SIGNA EXCITE MR SURGICAL OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 2, 2014

    LIST TB ULTRA WHITE FIRM PR-009305 EU

    FDA Adverse Event
    Malfunction ·SKILLMAN CONTRACT·Product code EFW·November 22, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 24, 2010

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP.·Product code NIQ·December 12, 2006

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021