BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    FILM DIGITZER, MODEL 2908 MAMMO PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    THREE PEG PATELLA 35MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 7, 2024

    MAXIMO II DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·November 1, 2012

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·June 23, 2015

    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·July 17, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022