BEUDAMED
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    BOARD, TRANSFER, FENDER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Ortho Specialties

    FDA UDI
    Young Innovations, Inc.·00843471162620·Trumpeted Bondable Non-Convertible Buccal Tube,...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111171796·LAHEY RETR SHR 1 PRONG 4 3/4"

    WBR XPRESS3.CARDIAC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Synermed ISE Reagents

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    28MM -4 LFIT V40 HEAD

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 30, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 10, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2010

    TAPERLOC 133 T1 PPS HO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 8, 2020

    TAPERLOC XR T1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·April 8, 2020

    TAPERLOC 133 MP TYPE1 PPS HO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·April 8, 2020

    TAPERLOC 133 FP TYPE1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWL·April 8, 2020

    TAPERLOC 133 T1 PPS SO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 8, 2020

    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

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

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