FDA applicant
Emi Medical, Inc.
FDA records 13 decisions for Emi Medical, Inc. (Mchenry, IL) from 1977 to 1979: 13 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Emi Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Emi Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Emi Medical, Inc.’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