FDA applicant
Edentec Corp.
FDA records 18 decisions for Edentec Corp. (Eden Prairie, MN) from 1985 to 1996: 18 510(k) clearances. Most are in product codes BZQ (Monitor, Breathing Frequency) and DQA (Oximeter). 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 Edentec Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Edentec Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Edentec 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