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

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    CLOSED CHEST DRAINAGE SET

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704294255·

    Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PINNACLE MTL INS NEUT28IDX48OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·June 13, 2014

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 16, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026