BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    MICRO-SURGICAL POWER INSTRUMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROGENIX

    FDA 510(k)
    FDA Class 2 ·Dental

    STELLAR

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

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

    DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

    FDA Adverse Event
    Malfunction ·XOMED MFG JACKSONVILLE·Product code ETN·October 18, 2012

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·August 17, 2010

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024