BEUDAMED
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    ALOKA ARIETTA 850

    FDA 510(k)
    FDA Class 2 ·Radiology

    ClearFit

    FDA UDI
    LONGEVITI NEURO SOLUTIONS LLC·00855113008098·Extra Small Curved

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM

    I45, I45S, I60, AND I60S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PATIENT SAFE LUER CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MAF·July 22, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 16, 2013

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019

    PEDICLE SCREW 6X45

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021