BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    OPERATION MICROSCOPE SOM 1

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

    FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    E-100 Electrosurgical Generator, SynchroSeal

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·August 6, 2010

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024