FDA applicant
Seamed Corp.
FDA records 18 decisions for Seamed Corp. (Bothell, WA) from 1982 to 1992: 18 510(k) clearances. Most are in product codes DTE (Pulse-Generator, Pacemaker, External) and DTC (Analyzer, Pacemaker Generator Function). 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 Seamed Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Seamed Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Seamed Corp.’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