FDA applicant
Contract Medical International, GmbH
FDA records 7 decisions for Contract Medical International, GmbH (Dresden, DE) from 2015 to 2025: 7 510(k) clearances. All are in product code DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 49 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Contract Medical International, GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Contract Medical International, GmbH’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 “Contract”
FDA records each applicant name separately; these may or may not be the same firm.