BEUDAMED
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    MERCURY MEDICAL T-PIECE RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 29, 2015

    NEONATAL PATIENT CIRCUIT KIT

    FDA Adverse Event
    Injury ·MERCURY MEDICAL·Product code CAI·September 21, 2015

    HINT AUDIOMETER, OR HINT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 24, 2013

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·September 16, 2014

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·April 19, 2011

    PROGREAT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026

    PROGREAT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 25, 2020

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 10, 2026

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 4, 2020

    AVALUS AORTIC TISSUE VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    PROGREAT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 26, 2026

    PROGREAT

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 28, 2025