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.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cosmo Pharmaceuticals and its 2 subsidiaries with 6 510(k) clearances, 6 AI-enabled devices and 1 drug application. The most recent is a 510(k) clearance dated May 29, 2026: GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US).
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 13, 3 entities
510(k) clearances: 6
AI-enabled devices: 6
Drug applications: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Cosmo Pharmaceuticals and its 2 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
120182018Records1vs 2017+1
02019Records0vs 2018−1
020202020Records0vs 2019+0
12021Records1vs 2020+1
020222022Records0vs 2021−1
12023Records1vs 2022+1
220242024Records2vs 2023+1
02025Records0vs 2024−2
120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
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
