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

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    AccuFill Bone Substitute Material

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402863·Guide Rod, Tibial Cone D14/L180

    MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

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

    AMBIT TUNNELER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    9735669 STEALTH S8 EM ENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 21, 2020

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 14, 2013

    ENDURANT STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 8, 2011

    CRE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code KNQ·September 24, 2008

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018