FDA applicant
Scimed Life Systems, Inc.
FDA records 111 decisions for Scimed Life Systems, Inc. (Maple Grove, MN) from 1977 to 1998: 109 510(k) clearances and 2 original PMA approvals. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 67 predicates, 62 of them its own earlier devices. 17 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Scimed Life Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Scimed Life Systems, Inc. since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Scimed Life Systems, 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 “Scimed”
FDA records each applicant name separately; these may or may not be the same firm.