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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OLYMPUS NA-10J-1 ASPIRATION NEEDLE

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

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970563·anteriors; shade BL4; mould BIS

    VIDAR VISION 2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    3M Comply Hydrogen Peroxide Indicator Tape

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRULIANT TIB IMP PSC INSERT SZ 2, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 26, 2024

    8 MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 20, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

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

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·July 31, 2014

    DA-400CIII

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EGS·May 26, 2015

    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