FDA applicant
Philips Medical Systems Nederland B.V.
FDA records 107 decisions for Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL) from 2005 to 2026: 106 510(k) clearances and 1 De Novo grant. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 155 predicates, 57 of them its own earlier devices. 489 recalls are linked to its devices, 24 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Medical Systems Nederland B.V.’s devices, and how often a recall has named them.
FDA decisions per year
8in 2025
2026 so far, outlined.
Recalls per year
80in 2026
Class I Class II/III not classified
Planning a device like Philips Medical Systems Nederland B.V.’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