BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    BAXA ADDISEAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERLING

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975063779·

    WOUND PROTECTOR/RETRACTOR

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

    BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012

    PALL CONSERVE 100 BREATHING CIRCUIT FILTER

    FDA Adverse Event
    Death ·PALL NEWQUAY·Product code CAH·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