BEUDAMED
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    ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Starbond Easy

    FDA UDI
    S & S Scheftner GmbH·04260207854196·Disc, 8 mm ø 98,3 mm / with edging

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327177329·C2 NerveMonitor, 4 Channel

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327277319·C2 NerveMonitor, 8 Channel

    VITALAB MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOSPITAL FULL FACE MASK VENTED

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·September 25, 2014

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·February 2, 2026

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    HAKIM VALVE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 31, 2013

    ECHELON*FLEX45 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2011

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·January 29, 2026

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·January 30, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·January 21, 2026

    IMPELLA 5.5

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·November 20, 2025

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code PYX·April 9, 2026

    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·October 9, 2019

    C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·October 9, 2019

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·February 10, 2026

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·September 28, 2025