BEUDAMED
    7 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·February 11, 2015

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020

    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016