175 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
FDA Enforcement
Class II
·Ongoing·Epitope Diagnostics, Inc.·November 18, 2020
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, INc.·November 15, 2023
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
FDA Enforcement
Class II
·Ongoing·Wiener Laboratories·March 14, 2018
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
FDA Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·May 6, 2026
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 4, 2026
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·August 7, 2024