FDA applicant
Thermo Fisher Scientific (Oxoid Ltd.)
FDA records 3 decisions for Thermo Fisher Scientific (Oxoid Ltd.) (Basingstoke, GB) from 2025 to 2026: 3 510(k) clearances. All are in product code JTN (Susceptibility Test Discs, Antimicrobial). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Thermo Fisher Scientific (Oxoid Ltd.)’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Thermo Fisher Scientific (Oxoid Ltd.)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Thermo”
FDA records each applicant name separately; these may or may not be the same firm.