FDA applicant
Pulsenmore, Ltd.
FDA records 1 decision for Pulsenmore, Ltd. (Omer, IL) in 2025: 1 De Novo grant. All are in product code SGJ (Ultrasound Imaging System For Acquiring Images…). 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 Pulsenmore, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2025high 1 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Pulsenmore, 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) Report