FDA applicant
Emde Corp.
FDA records 4 decisions for Emde Corp. (Mchenry, IL) from 1977 to 1986: 4 510(k) clearances. Most are in product codes CBT (Arterial Blood Sampling Kit) and KNT (Tubes, Gastrointestinal (And Accessories)). 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 Emde Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Emde Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Emde 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