BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    GIRARD SUNGLASSES (NON-PRESCRIPTION)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973998·UniTip High Resolution Catheter 8F

    EFFRON PAROTID RETRACTOR

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

    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    CRYSTALLINE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    4F-80CM PREM SYNTEL CATHETER

    FDA Adverse Event
    Injury ·APPLIED MEDICAL·Product code DXE·November 26, 2012

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012