9 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·February 28, 2024
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·December 14, 2022
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Enforcement
Class II
·Completed·Philips North America Llc·December 27, 2023
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 10, 2025
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·March 23, 2022
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