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Thermo Fisher Scientific

Diagnostics makerAI in United StatesAI. FDA records under 7 spellings of its name, each linked to the record.

  • Records across the group: 1,412, 60 entitiesAI
  • 510(k) clearances: 1,190
  • Device recalls: 218
  • Drug recalls: 2
  • Drug applications: 2

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Thermo Fisher Scientific and its 59 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Oct 15, 2026Oncomine ™ Dx Express TestK260827 · SBY510(k) clearances
Jun 25, 2026EliA CTD 13 ScreenK253367 · LLL510(k) clearances
Oct 17, 2025Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserK250159 · SGG510(k) clearances
Sep 25, 2025The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLK252062 · JWY510(k) clearances
Sep 5, 2025The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLK250575 · JWY510(k) clearances
Aug 28, 2025The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLK252014 · JWY510(k) clearances
Jun 30, 2025The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mLK250990 · JWY510(k) clearances
Jun 20, 2025The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.K242843 · JWY510(k) clearances
Jan 17, 2023Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher SciClass II · CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to Drug recalls
Jan 17, 2023Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen PharmaceuticClass II · CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to Drug recalls
Oct 29, 2013MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and disClass III · Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stDevice recalls

Subsidiaries and Divisions

59 firms in the Thermo Fisher Scientific group, most records first

Canada and Imports

Across the Thermo Fisher Scientific group, matched by company name
Active Health Canada device licences
285, as of Nov 10, 2026

Names and Identifiers

Appears as
Thermo Fisher ScientificThermo Fisher Scientific (Asheville) LLCThermo Fisher Scientific (Oxoid Ltd.)Thermo Fisher Scientific (Monterrey)Thermo Fisher Scientific, Inc.Thermo Fisher Scientific (Nalge Nunc Intl)

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.