Oxoid Limited (Part of Thermo Fisher Scientific) is one of 195 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Oxoid Limited (Part of Thermo Fisher Scientific) - FDA 510(k) Cleared...
Recent clearances: Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5, Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20, Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
7
Total
7
Cleared
0
Denied
Oxoid Limited (Part of Thermo Fisher Scientific) has 7 FDA 510(k) cleared medical devices. Based in Basingstroke, GB.
Latest FDA clearance: Mar 2024. Active since 2018. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Oxoid Limited (Part of Thermo Fisher Scientific) Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Oxoid Limited (Part of Thermo Fisher Scientific)
7 devices
Cleared
Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
Microbiology
276d
Cleared
Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
Microbiology
67d
Cleared
Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
Microbiology
672d
Cleared
Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
Microbiology
217d
Cleared
Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
Microbiology
224d
Cleared
Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
Microbiology
352d
Cleared
Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
Microbiology
65d