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

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    SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970567·anteriors; shade BL4; mould ITL

    NANOCLAVE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 10, 2020

    Tempus Pro Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGHT, EXAMINATION, MEDICAL (MEL)

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

    NANOCLAVE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·February 10, 2020

    DYNASTY(R) COCR LINER

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·February 20, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 25, 2011

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 31, 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