FDA applicant
Philips Hearing Instruments Co.
FDA records 20 decisions for Philips Hearing Instruments Co. (Mahwah, NJ) from 1991 to 1997: 20 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Philips Hearing Instruments Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Philips Hearing Instruments Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Philips Hearing Instruments Co.’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