BEUDAMED
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    STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813035856·Reamers With Silicone Stops 31MM #25

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931277·BIT, CRUCIFORM 6.0MM 1/4 SQ

    Bosma Enterprises

    FDA UDI
    Bosma Enterprises·00818634025418·Opportunity Pro Nitrile Exam Glove Medium 100/Box

    MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS

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

    Heavy Double Flexible Tipped Wire Guide

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 28, 2025

    CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 28, 2025

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·December 2, 2008

    TECNIS MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·September 16, 2011

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 29, 2013

    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

    FDA Enforcement
    Class II ·Ongoing·Spectranetics Corporation·December 25, 2024

    BD NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·April 3, 2026

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013