FDA applicant
Scholten Surgical Instruments, Inc.
FDA records 8 decisions for Scholten Surgical Instruments, Inc. (Redwood City, CA) from 1985 to 2007: 8 510(k) clearances. Most are in product codes JEB (Table, Surgical With Orthopedic Accessories…) and GAD (Retractor). 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 Scholten Surgical Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Scholten Surgical Instruments, 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