FDA applicant
Amba Medical, Ltd.
FDA records 1 decision for Amba Medical, Ltd. (Bristol Bs4 5qh, GB) in 1999: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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 Amba Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Amba Medical, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Amba 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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