FDA applicant
Phoenix Innovative Healthcare Manufacturers Pvt., Ltd.
FDA records 2 decisions for Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. (Mahape, Navi Mumbai, IN) from 2021 to 2023: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and LRX (Case, Contact Lens). Its devices cite 2 predicates, 0 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 Phoenix Innovative Healthcare Manufacturers Pvt., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Phoenix Innovative Healthcare…’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) ReportOther applicant names beginning “Phoenix”
FDA records each applicant name separately; these may or may not be the same firm.