FDA applicant
Philips Medizin Systeme Boblingen GmbH
FDA records 22 decisions for Philips Medizin Systeme Boblingen GmbH (Boeblingen, DE) from 2001 to 2026: 22 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and HGM (System, Monitoring, Perinatal). Since 2016 its 510(k)s took a median of 200 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 120 predicates, 13 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Philips Medizin Systeme Böblingen GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Medizin Systeme Boblingen GmbH’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Philips Medizin Systeme Boblingen GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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