FDA applicant
American Medical Endoscopy, Inc.
FDA records 3 decisions for American Medical Endoscopy, Inc. (Doral, FL) from 2025 to 2026: 3 510(k) clearances. Most are in product codes FAJ (Cystoscope And Accessories, Flexible/Rigid) and HIH (Hysteroscope (And Accessories)). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 0 of them its own earlier devices. 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 American Medical Endoscopy, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like American Medical Endoscopy, Inc.’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) Report