BEUDAMED
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    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493934669·AVANOS* Single-Shot Epidural Trays

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651934663·HYH,EP TRY,S-SHOT,-,-,10

    20 ML BD LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 20, 2020

    VIZION

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SYNTHEMED DEVICE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MERGE CARDIO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·October 17, 2014

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·June 21, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·July 12, 2011

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025