BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    2200I PHYSIOLOGICAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Shoreline™ ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981143992·Trial Rasp, 20x15x8mm, 7 Deg Lordosis

    SMARTO

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CRYSTALLINE ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 9, 2010

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    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