BEUDAMED
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    FIRST AID KIT(S)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OSTEOMED HEADLESS CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYMBIQ 3.13 SINGLE C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 19, 2014

    ACCUJECT 2.2 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDICEL AG·Product code HQL·February 12, 2013

    OPTI-FREE REPLENISH

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH/ALCON LABORATORIES, INC.·Product code LPN·January 14, 2011

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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