FDA applicant
Misten Medical Corp.
FDA records 4 decisions for Misten Medical Corp. (Germantown, TN) from 1995 to 1996: 4 510(k) clearances. Most are in product codes ETD (Tube, Tympanostomy) and ETB (Prosthesis, Partial Ossicular Replacement). 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 Misten Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Misten Medical Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Misten Medical 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