Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medgyn Products with 5 510(k) clearances and 1 drug recall. The most recent is a drug recall dated Jul 3, 2018: Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 3, 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGClass II · CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufac | Drug recalls |
| Nov 23, 2015 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterK143669 · MQF | 510(k) clearances |
| Jun 12, 2013 | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPEK122973 · HEX | 510(k) clearances |
| Jan 26, 1995 | BOTTLE COLLECTION SETK945179 · HGF | 510(k) clearances |
| May 6, 1988 | LAMINARIAK880196 · HDY | 510(k) clearances |
| Mar 14, 1988 | GYNESCOPEK880195 · HEX | 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
