BEUDAMED
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    CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    E.R.C.P. CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDSURG VASCULAR ACCESS PORT INFUSION TRAY

    FDA 510(k)

    EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    FDA Adverse Event
    Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

    UNSPECIFIED CENTRAL LINE CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 23, 2014

    TBD

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·February 15, 2013

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·January 20, 2011

    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

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