BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    SIMS HYPERINFLATION BAG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970785·anteriors; shade C2; mould UBIM

    DYNASTY ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    MONITOR, RESPIRATORY, TWO-GAS, RDC

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

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

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

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

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

    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