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

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    TELESCOPING BEDRAILS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NUFACE, MODEL NU-4003

    FDA 510(k)
    FDA Class 2 ·Neurology

    Omni Foot Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MUSTANG¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·October 4, 2012

    ACE HARMONIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY·Product code GEI·April 14, 2014

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·July 22, 2010

    SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.

    FDA Recall
    Terminated ·Nonin Medical, Inc·Product code DQA·November 25, 2014

    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