FDA applicant
Shippert Medical Technologies Corp.
FDA records 13 decisions for Shippert Medical Technologies Corp. (Englewood, CO) from 1995 to 2010: 13 510(k) clearances. Most are in product codes EMX (Balloon, Epistaxis) and MUU (System, Suction, Lipoplasty). Its devices cite 12 predicates, 4 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shippert Medical Technologies Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
7in 2018
Class I Class II/III not classified
Planning a device like Shippert Medical Technologies 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) Report