8 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Vaginal PH Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·September 6, 2023
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
FDA Enforcement
Class II
·Ongoing·Hologic, Inc.·March 25, 2026
HPV Antigen Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·February 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·February 19, 2025
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
FDA Enforcement
Class II
·Ongoing·Kreatech Biotechnology Bv·December 4, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·November 6, 2024