BEUDAMED
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    IRRIGO Wound Wash Jet System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KSEA MINIATURE TELESCOPE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIAC TRIGGER MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 19, 2024

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 16, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 5, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 2, 2025

    LIGASURE IMPACT

    FDA Adverse Event
    Death ·COVIDIEN LP, (VALLEYLAB)·Product code GEI·October 22, 2008

    TECNIS MULTIFOCAL 1 PIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·August 12, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code BSP·August 5, 2025

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025