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

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    LIQUID GLUCOSE (OXIDASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970781·anteriors; shade B2; mould UBIM

    MX50N(MX50YQS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTROPHOTOMETER SYSTEM, MODEL AA-475

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·February 20, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 25, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·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