BEUDAMED
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    Aptima® Chlamydia trachomatis Assay

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464030781·OTICON F300 MINIRITE T C092

    NEUROQ 3.6

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE

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

    CERTAIN¿ UCLA CASTABLE NON-HEXED CYLINDER 4.1MM(D) W/LARGE DIA. TI SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code DZE·January 20, 2023

    OCCLUSION BALLON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KOD·November 7, 2008

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 15, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025