BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    myPatch-s

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    AFFINITY 4 BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·October 29, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Alcon Custom Pak

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