FDA applicant
Superdimension, Ltd.
FDA records 12 decisions for Superdimension, Ltd. (Plymouth, MN) from 2004 to 2012: 12 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 19 predicates, 13 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Superdimension, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Superdimension, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Superdimension, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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