BEUDAMED
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    Glaucoma Module

    FDA 510(k)
    FDA Class 2 ·Radiology

    CORTRAK* 2 Enteral Access System

    FDA UDI
    Avanos Medical, Inc.·00350770456515·CORTRAK* 2 Enteral Access System - Post Rail Clamp

    COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·July 1, 2005

    KERR GEL ETCHANT

    FDA 510(k)
    FDA Class 2 ·Dental

    H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PORTEX NEONATAL/PEDIATRIC TRACHEAL INTIBUATION KIT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD.·Product code BTR·September 15, 2014

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    HLC-723 G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024

    G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021