FDA applicant
Creagh Medical, Ltd.
FDA records 6 decisions for Creagh Medical, Ltd. (Ballinasloe, IE) from 2010 to 2023: 6 510(k) clearances. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Creagh Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Creagh Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Creagh Medical, 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 “Creagh”
FDA records each applicant name separately; these may or may not be the same firm.