10 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·November 15, 2023
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·December 17, 2025
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
FDA Enforcement
Class II
·Ongoing·SenTec AG·September 27, 2023
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 24, 2024