FDA applicant
U.S. Shizai Corp.
FDA records 5 decisions for U.S. Shizai Corp. (Mchenry, IL) from 1980 to 1986: 5 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EKA (File, Margin Finishing, Operative). 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 U.S. Shizai Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for U.S. Shizai Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like U.S. Shizai 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