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

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    K-CAP-I, STERILE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Physio Flex Annuloplasty Ring

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MJS POSTERIOR STABILIZED KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·October 31, 2023

    TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code EWY·June 5, 2023

    MTS KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·November 2, 2010

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·January 8, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015