FDA applicant
Craigwell Electronics, Ltd.
FDA records 3 decisions for Craigwell Electronics, Ltd. (Wiltshire Sn2 4bj, GB) in 1986: 3 510(k) clearances. Most are in product codes KHL (Hearing Aid, Master) and ESD (Hearing Aid, Air-Conduction, Prescription). 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 Craigwell Electronics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Craigwell Electronics, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Craigwell Electronics, 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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