Academic or research institutionLabelled 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 5 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Mass General Brigham and its 5 subsidiaries with 4 510(k) clearances, 2 drug applications and 1 drug recall. The most recent is a 510(k) clearance dated Sep 11, 2026: GSPE Spacer.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Mass General Brigham and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 11, 2026 | GSPE SpacerK260063 · JWH | 510(k) clearances |
| Feb 17, 2021 | Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts GClass II · Lack of Assurance of Sterility | Drug recalls |
| Jan 30, 2019 | Boston Keratoprosthesis, Type I LuciaK182986 · HQM | 510(k) clearances |
| May 10, 2013 | BOSTON KERATOPROSTHESIS OR BOSTON KPROK121203 · HQM | 510(k) clearances |
| Jul 20, 2001 | NORTHEAST PROTON THERAPY CENTERK983332 · LHN | 510(k) clearances |
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
