BEUDAMED
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    EXPLORER LIVER (PASSIVE TRACKING)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964072789·The ENDO CARRY-ON Procedure Kit contains all of...

    3012307300-2022-02917

    FDA Adverse Event
    Malfunction ·NULL·Product code LHI·February 8, 2022

    ALLERSHARP ALLERGY SKIN TESTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·January 10, 2022

    SMARTSET HV BONE CEMENT 40G

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code LOD·May 9, 2013

    SITTER ELITE

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 15, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011

    TRILOGY EVO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·June 2, 2022

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 8, 2024

    Beacon Tip Torcon NB

    FDA UDI
    COOK INCORPORATED·00827002114371·Beacon Tip Torcon NB Advantage Catheter

    Torcon NB

    FDA UDI
    COOK INCORPORATED·00827002471832·Torcon NB Advantage Catheter

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025