BEUDAMED
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    RANDOX GENTAMICIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Dimora

    FDA UDI
    Winner Medical Co., Ltd.·16941094064183·Sacrum Silicone AG Foam Dressing with Border

    Dimora

    FDA UDI
    Winner Medical Co., Ltd.·16941094085911·Sacrum Silicone Ag Foam Dressing with border

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450379073·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033449172·

    TINA-QUANT ALPHA-1 ANTITRYPSIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    LIGTHSPEED 3.0 CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMFORT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025

    PFC MOD DOME PATELLA 35MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2005

    COMFORT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 12, 2025

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 4, 2011

    DXTEND HIGHMO PE CUP D38 +3MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWS·March 12, 2008

    4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021