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

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    Filters Regulation: Us FDA ×

    R&D PART NOS. 5490, 5541, 5358, 5497

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    OPUS RUBELLA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPACER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HEART START XL

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES, INC·Product code MKJ·January 7, 2013

    ENDOTAK DSP

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·January 4, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 21, 2014

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·September 8, 2025

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023