FDA applicant
Clement Clarke Intl., Ltd.
FDA records 6 decisions for Clement Clarke Intl., Ltd. (Harlow, GB) from 1997 to 2006: 6 510(k) clearances. Most are in product codes BZH (Meter, Peak Flow, Spirometry) and HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Clement Clarke Intl., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Clement Clarke Intl., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Clement Clarke Intl., Ltd.’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) ReportOther applicant names beginning “Clement”
FDA records each applicant name separately; these may or may not be the same firm.