BEUDAMED
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    AUTOMATED ELECTROPHORESES MACHINE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198895·AK3 Congruent Insert Trial Size 1, 11mm

    NEU_ENS_STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·December 9, 2011

    DD Solid Connect® CAD/CAM Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FORTIFY DR, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 5, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012

    KAPPA 900 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2010

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

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

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025