FDA applicant
Assured Sound Laboratories, Inc.
FDA records 1 decision for Assured Sound Laboratories, Inc. (Denver, CO) in 1987: 1 510(k) clearance. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Assured Sound Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Assured Sound Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Assured Sound Laboratories, 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) ReportOther applicant names beginning “Assured”
FDA records each applicant name separately; these may or may not be the same firm.