FDA applicant
Medisim, Ltd.
FDA records 7 decisions for Medisim, Ltd. (Neve Ilan, IL) from 1999 to 2015: 7 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 13 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medisim, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2007high 1 (2010) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medisim, 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