BEUDAMED
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    JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828113342·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828134422·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828112680·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828113533·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828113434·GEN4 DIGITAL

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828107198·GEN4 Direct Access

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828112512·GEN4 DIGITAL

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 11, 2021

    SHAVER ABLATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ATTAIN PERFORMA MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO VILLALBA·Product code OJX·October 23, 2025

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

    PERFIX CONTINUOUS EPIDURAL TRAYS

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code CAZ·April 23, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

    RX HERCULINK ELITE STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·August 7, 2008

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015