FDA applicant
Carapace, Inc.
FDA records 22 decisions for Carapace, Inc. (Broken Arrow, OK) from 1979 to 1994: 22 510(k) clearances. Most are in product codes LRO (General Surgery Tray) and LGF (Component, Cast). 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 Carapace, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Carapace, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Carapace, 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