FDA applicant
Applied Medical Resources
FDA records 115 decisions for Applied Medical Resources (Rancho Santa, CA) from 1992 to 2026: 115 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 67 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 87 predicates, 52 of them its own earlier devices. 32 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Applied Medical Resources Corp.”, “Applied Medical Resources Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Applied Medical Resources’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Applied Medical Resources’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