FDA applicant
Northstar Healthcare Holdings
FDA records 10 decisions for Northstar Healthcare Holdings (Hamilton, Bermuda, IE) from 2011 to 2013: 10 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Northstar Healthcare Holdings Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Northstar Healthcare Holdings’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Northstar Healthcare Holdings’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