BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aquilion Precision (TSX-304A/4) V10.10 with AiCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRAINET

    FDA 510(k)
    FDA Class 2 ·Neurology

    MOSAIC

    FDA Adverse Event
    Injury ·SPINAL ELEMENTS, INC.·Product code ODP·November 6, 2008

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0

    FDA Adverse Event
    ROCHE MOLECULAR SYSTEMS·Product code MZF·August 24, 2011

    SPECTRUM WIRELESS BATTERY MODULE G

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 5, 2013

    CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH, AMS

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code GKT·May 6, 1998

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    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