BEUDAMED
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    CONVEX PROBE, PVE-382M

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONVEX PROBE, PVE-393M

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONVEX PROBE, PVE-382M

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX·Product code FDF·November 10, 2021

    AMPLATZER VASCULAR PLUG

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code KRD·June 22, 2009

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·October 18, 2021

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·CORCYM CANADA CORP.·Product code LWR·August 31, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·June 22, 2018

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·CORCYM CANADA CORP.·Product code LWR·August 31, 2021

    CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 25, 2009

    ONX AORTIC ANATOMIC 21

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·October 19, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·April 20, 2018

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA? PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 22, 2014

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·October 27, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·September 10, 2021

    SAPIEN M3 VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPU·August 25, 2023

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·October 11, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·December 15, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 10, 2021