FDA applicant
Widemed, Ltd.
FDA records 3 decisions for Widemed, Ltd. (Herzliya, IL) from 2003 to 2011: 3 510(k) clearances. All are in product code MNR (Ventilatory Effort Recorder). Its devices cite 8 predicates, 2 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 Widemed, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Widemed, 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