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

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    ADVANTAGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InActiv Blue

    FDA 510(k)
    FDA Class 2 ·Microbiology

    +2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·July 5, 2023

    APOGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·January 10, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 9, 2014

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025