FDA applicant
Thomas Medical Products, Inc.
FDA records 23 decisions for Thomas Medical Products, Inc. (Malvern, PA) from 1990 to 2013: 23 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 13 predicates, 6 of them its own earlier devices. 17 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Thomas Medical Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Thomas Medical Products, Inc.’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 “Thomas”
FDA records each applicant name separately; these may or may not be the same firm.