BEUDAMED
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    Filters Classification: Class I × Status: Ongoing × Clear all

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    FDA Enforcement
    Class I ·Ongoing·FHC, Inc.·November 20, 2024

    Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 3, 2024

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·March 30, 2022

    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023

    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

    FDA Enforcement
    Class I ·Ongoing·LeMaitre Vascular, Inc.·April 8, 2020

    HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc·June 15, 2022

    DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

    FDA Enforcement
    Class I ·Ongoing·Respironics California, LLC·July 28, 2021

    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

    FDA Enforcement
    Class I ·Ongoing·Respironics California, LLC·July 28, 2021

    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

    FDA Enforcement
    Class I ·Ongoing·Ethicon Endo-Surgery Inc·May 28, 2025

    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

    FDA Enforcement
    Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

    Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100

    FDA Enforcement
    Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

    Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

    FDA Enforcement
    Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

    FDA Enforcement
    Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

    FDA Enforcement
    Class I ·Ongoing·Trokamed GmbH·January 22, 2025

    Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

    FDA Enforcement
    Class I ·Ongoing·Trokamed GmbH·January 22, 2025

    Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

    FDA Enforcement
    Class I ·Ongoing·Trokamed GmbH·January 22, 2025

    Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

    FDA Enforcement
    Class I ·Ongoing·Trokamed GmbH·January 22, 2025