BEUDAMED
    56 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

    FDA Recall
    Open, Classified ·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code IYB·October 16, 2025

    Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code LCO·December 15, 2025

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code KPR·September 15, 2025

    HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.

    FDA Recall
    Open, Classified ·Puritan Medical Products Company, Llc·Product code KXG·February 21, 2024

    Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 782136

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782105

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·September 3, 2024

    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KRR·December 22, 2022

    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code KWT·August 21, 2018