Thermo Fisher Scientific (Oxoid Ltd.) is one of 365 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Thermo Fisher Scientific (Oxoid Ltd.) - FDA 510(k) Cleared Devices
Recent clearances: Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60, Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10, Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
3
Total
3
Cleared
0
Denied
Thermo Fisher Scientific (Oxoid Ltd.) has 3 FDA 510(k) cleared medical devices. Based in Basingstroke, GB.
Latest FDA clearance: Jul 2026. Active since 2025. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Thermo Fisher Scientific (Oxoid Ltd.) Filter by specialty or product code using the sidebar.
3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Thermo Fisher Scientific (Oxoid Ltd.)
3 devices
Cleared
Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
Microbiology
56d
Cleared
Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
Microbiology
219d
Cleared
Jun 12, 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
Microbiology
90d