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

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    ARGYLE INDWELL FEEDING TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Synguard Nitrile Exam Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VARIOTHERM

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

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·April 17, 2019

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQV·May 15, 2014

    MEDCARE

    FDA Adverse Event
    MEDCARE PRODUCTS INC.·Product code FNG·October 10, 2012

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·August 30, 2010

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015