FDA applicant
Spembly Medical, Ltd.
FDA records 17 decisions for Spembly Medical, Ltd. (England, GB) from 1976 to 1993: 17 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Spembly Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Spembly Medical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Spembly Medical, 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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