BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    PNEUMO-MATIC INSUFFLATION NEEDLE

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

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970788·anteriors; shade D2; mould UBIM

    CyberKnife Treatment Delivery System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECSYS CORTISOL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2520274-2013-01073

    FDA Adverse Event
    Injury ·Product code HWC·February 20, 2013

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 25, 2011

    MOSAIC ULTRA PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code LWR·July 31, 2014

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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