BEUDAMED
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    INTRAMEDULARY FIXATION ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·February 11, 2022

    PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 6, 2010

    ENDURITY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·December 10, 2012

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    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