BEUDAMED
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    HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037985·Unitek(TM) Bicuspid Band General Purpose Wide L...

    neon™ superior spine system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536007424·neon hook, straight, short

    Monterey™ AL

    FDA UDI
    VB Spine LLC·10888857586925·C/C AL Implant Inserter 10/12 mm

    EXPEDIUM MIS SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONICA AN24

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALARIS® PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·November 12, 2018

    LANCET DEVICE SNSRTR CMFRT EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 27, 2011

    NI

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 1, 2022

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021