BEUDAMED
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    ACCESS HYBRITECH P2PSA

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code OYA·June 20, 2023

    UNKNOWN EGIA TRI STAPLE

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·April 6, 2022

    NIM® EMG

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·September 25, 2024

    NIM® EMG

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·September 25, 2024

    BLAKE DRAIN UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GBX·March 1, 2018

    BARDEX® ALL-SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·February 12, 2024

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·May 2, 2018

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·May 2, 2018

    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code OYA·May 17, 2023

    KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Recall
    Terminated ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020

    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Recall
    Terminated ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020

    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Recall
    Terminated ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020

    Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Recall
    Terminated ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020

    P2psa

    FDA classification
    FDA Class 3 ·P2psa

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

    Koya Ripple

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOYA IS INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HOYA Corporation

    FDA registration
    HOYA Corporation·1 product·🇧🇬 Bulgaria

    HOYA LAMPHUN LTD., HOYA Eye Care Thailand

    FDA registration
    HOYA LAMPHUN LTD., HOYA Eye Care Thailand·2 products·🇹🇭 Thailand

    Mini MaxLock Extreme™

    FDA UDI
    TORNIER, INC.·00846832044863·Alpha Y-Plate