FDA applicant
American Edwards Laboratories
FDA records 89 decisions for American Edwards Laboratories (Santa Ana, CA) from 1980 to 1987: 89 510(k) clearances. Most are in product codes HRX (Arthroscope) and FRN (Pump, Infusion). 10 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Edwards Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Edwards Laboratories since 2007.
Recalls per year
9in 2012
2007high 9 (2012) · low 0 (2007)2026
Class I Class II/III not classified
Planning a device like American Edwards Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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