BEUDAMED
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    PALOMAR SPALIGHT PULSED LIGHT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    SPIROL EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX FIXATION PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    APEX KNEE SYSTEM - PS-R

    FDA Adverse Event
    Injury ·OMNLIFE SCIENCE, INC.·Product code JWH·March 12, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·August 12, 2014

    SLIMLINE EZ SINGLE USE

    FDA Adverse Event
    Malfunction ·LUMENIS, INC.·Product code GEX·November 30, 2007

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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