BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LumaFlex Plus Double J stent, 2 open tips, Ch/Fr6/L.22cm, without wire

    FDA UDI
    Promepla·03700512967620·

    CALEX CONDITIONER

    FDA 510(k)
    FDA Class 2 ·Dental

    HDR MIAMI APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CURRENT PLUS DR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·April 11, 2011

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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