FDA applicant
Pt. Haloni Jane
FDA records 2 decisions for Pt. Haloni Jane (Medan, ID) from 1994 to 2006: 2 510(k) clearances. Most are in product codes OPE (Unnamed device) and LYY (Latex Patient Examination Glove). 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 Pt. Haloni Jane’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt. Haloni Jane since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt. Haloni Jane’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