FDA applicant
Rochester Medical Corp.
FDA records 14 decisions for Rochester Medical Corp. (Stewartville, MN) from 1990 to 2013: 13 510(k) clearances and 1 original PMA approval. Most are in product codes MJC (Catheter, Urological (Antimicrobial) And…) and EZL (Catheter, Retention Type, Balloon). Its devices cite 12 predicates, 6 of them its own earlier devices. 37 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Rochester Medical Corp.’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 Rochester Medical Corp.’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 “Rochester”
FDA records each applicant name separately; these may or may not be the same firm.