BEUDAMED
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    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Enforcement
    Class I ·Terminated·Codman & Shurtleff, Inc.·January 29, 2014

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    FDA Enforcement
    Class I ·Ongoing·SD Biosensor, Inc.·May 31, 2023

    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.

    FDA Enforcement
    Class I ·Ongoing·SD Biosensor, Inc.·March 23, 2022

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016

    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·April 24, 2019

    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 27, 2025

    Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 6, 2025

    Ventilator HAMILTON-C6, PN: 160021

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·June 26, 2024

    HAMILTON-C6 Intensive Care Ventilator, REF: 160021

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical AG·August 31, 2022

    HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

    FDA Enforcement
    Class I ·Terminated·Hamilton Medical AG·July 17, 2019

    Pediatric care bed; Product Designation: KayserBett IDA;

    FDA Enforcement
    Class I ·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026

    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·February 25, 2026

    Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·February 25, 2026

    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·February 25, 2026

    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·December 3, 2025

    OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·October 22, 2025

    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·October 22, 2025

    EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·October 22, 2025

    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

    FDA Enforcement
    Class I ·Ongoing·Olympus Corporation of the Americas·October 22, 2025