BEUDAMED
    23 results · 25ms · Sources: EU EUDAMED, US FDA

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    CorPath 200 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

    BD SAFETYGLIDE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 29, 2020

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 27, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·June 29, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·September 2, 2008

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 13, 2023

    AXIOS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024

    TRU CC TIB INSERT SIZE 5, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 24, 2025

    LOGIC CC FEMORAL SIZE 4, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 12, 2023

    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 Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    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