BEUDAMED
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    CUE FERTILITY MONITOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEGA POWER ELECTROSURGICAL GENERATOR

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

    Cardinal Health External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    35 CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·May 22, 2014

    N/A

    FDA Adverse Event
    Malfunction ·ASCENT·Product code KCY·October 1, 2010

    REPLY

    FDA Adverse Event
    Injury ·SORIN C.R.M., S.R.L.·Product code NVZ·November 16, 2012

    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