BEUDAMED
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    Filters Regulation: Us FDA ×

    Revolution External Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364728·TL Offset Handle

    LOBO Vascular Occlusion System (model LOBO-5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 18, 2008

    SECURE ACUTE CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 25, 2011

    ACCOLADE TMZF HIP STEM #5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·July 18, 2013

    INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN

    FDA Adverse Event
    Malfunction ·Product code FOZ·June 30, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025