FDA applicant
ClearStream Technologies, Ltd.
FDA records 7 decisions for ClearStream Technologies, Ltd. (Wexford, IE) from 2008 to 2011: 7 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 6 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 ClearStream Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like ClearStream Technologies, 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) Report