FDA applicant
Bioshield, Inc.
FDA records 1 decision for Bioshield, Inc. (Modesto, CA) in 1989: 1 510(k) clearance. All are in product code FYB (Gown, Patient). 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 Bioshield, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioshield, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioshield, 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) Report