BEUDAMED
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    BODAI SUCTION -SAFE 4

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112410·Awl Tap, 4.5 mm, Fixed Sleeve

    NEUROSOFT'S SOURCE

    FDA 510(k)
    FDA Class 2 ·Neurology

    KLS Martin Individual Patient Solutions (IPS) Planning System

    FDA 510(k)
    FDA Class 2 ·Dental

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    6.5CM ADULT CRANIOTOME ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    BD PLASTIPAK SYRINGE LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 30, 2019

    BD PLASTIPAK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 12, 2019

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 24, 2019

    SYRINGE 20ML LL 120/PKG

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 29, 2019

    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