BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2013

    DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Radiology

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 11, 2013

    SURGISIS BIODESIGN COMPLEX HERNIA GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH INC.·Product code GXQ·September 17, 2008

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·June 8, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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