BEUDAMED
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    TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Suretrak2

    FDA UDI
    MEDTRONIC NAVIGATION, INC.·00643169654747·ACC 961-573 SURETRAK2 COMBO SYSTEM

    N/A

    FDA UDI
    MEDTRONIC NAVIGATION, INC.·00721902467745·ACC 961-573 SURETRAK2 COMBO SYSTEM

    FilmArray RP EZ Control Panel M265

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    UNSPECIFIED CENTRAL LINE TRANSDUCER SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024

    AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 24, 2021

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 16, 2014

    JAGWIRE¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·February 14, 2013

    PVS 2000 SYNCHRO2 GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·January 14, 2011

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017