BEUDAMED
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    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 15, 2025

    ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ATR TECNIKA

    FDA 510(k)
    FDA Class 1 ·Dental

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    ASCENDRA INTRODUCER SHEAT SET

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·March 13, 2013

    POLYURETHANE CONTRAST INJECTION LINE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·January 28, 2011

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 9, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·November 1, 2021

    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·September 25, 2024

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024