BEUDAMED
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    SPEACELABS MULTIGAS MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Andrews2™

    FDA UDI
    Ortho Organizers, Inc.·00190707102579·.018 x .025 LO Andrews²™ Ortholoy-Blue .46 x .6...

    MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 27, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 21, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 30, 2018

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 3, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 12, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·December 21, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·November 26, 2025

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 5, 2021

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Injury ·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

    ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025