FDA applicant
Teleflex Medical
FDA records 46 decisions for Teleflex Medical (Morrisville, NC) from 2003 to 2026: 45 510(k) clearances and 1 original PMA approval. Most are in product codes GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) and FZP (Clip, Implantable). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 81 predicates, 19 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Teleflex Medical, LLC”, “Teleflex Medical Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Teleflex Medical’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Teleflex Medical’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 “Teleflex”
FDA records each applicant name separately; these may or may not be the same firm.