BEUDAMED
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    VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RHEUMAGEN RF T-CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PECTUS SYSTEM SHAFER 9 TI PECTUS BAR

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·February 19, 2020

    PECTUS SYSTEM SHAFER 9.5 TI PECTUS BAR

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·February 19, 2020

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·February 15, 2013

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·January 19, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026