BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACUITY PRO LEAD DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 16, 2022

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·November 6, 2014

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·July 28, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·July 18, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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