FDA applicant
Navotek Medical, Ltd.
FDA records 2 decisions for Navotek Medical, Ltd. (Philedelphia, PA) from 2011 to 2012: 2 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). 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 Navotek Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2011high 1 (2011) · low 0 (2013)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Navotek Medical, 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