FDA applicant
Osbon Medical Systems, Ltd.
FDA records 4 decisions for Osbon Medical Systems, Ltd. (Augusta, GA) from 1989 to 1991: 4 510(k) clearances. Most are in product codes LKY (Device, External Penile Rigidity) and KMJ (Lubricant, 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 Osbon Medical Systems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Osbon Medical Systems, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Osbon Medical Systems, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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