BEUDAMED
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    INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Mtira

    FDA UDI
    Kalitec Direct LLC·B07307K0157080·Trial Drill Guide Tube, 8mm

    RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM

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

    M/G UNICOMPARTMENTAL TENSION GAUGE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LXH·December 1, 2010

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 15, 2013

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 7, 2014

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015