FDA applicant
Encore Medical L.P.
FDA records 85 decisions for Encore Medical L.P. (Austin, TX) from 2002 to 2026: 85 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 227 predicates, 107 of them its own earlier devices. 122 recalls are linked to its devices.
FDA’s records also spell it “Encore Medical Corporation”, “Encore Medical, Inc.”, “Encore Medical, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Encore Medical L.P.’s devices, and how often a recall has named them.
FDA decisions per year
7in 2025
2026 so far, outlined.
Recalls per year
7in 2026
Class I Class II/III not classified
Planning a device like Encore Medical L.P.’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 “Encore”
FDA records each applicant name separately; these may or may not be the same firm.