BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Legacy™ Titanium Non-Engaging Temporary Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111993·

    LithoVue System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALARIS SAFETY MALE LUER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTLIFE LARGE ASPTC HOUSING

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·June 6, 2014

    AXIALIF 2L

    FDA Adverse Event
    Injury ·TRANS1·Product code KWQ·August 24, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·September 21, 2010

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    FDA Adverse Event
    Malfunction ·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020

    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