FDA applicant
Hemcon Medical Technologies Europe, Ltd.
FDA records 3 decisions for Hemcon Medical Technologies Europe, Ltd. (Portland, OR) from 2010 to 2012: 3 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hemcon Medical Technologies Europe, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Hemcon Medical Technologies Europe, Ltd.’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 “Hemcon”
FDA records each applicant name separately; these may or may not be the same firm.