FDA applicant
Philips Medical Systems Dmc GmbH
FDA records 19 decisions for Philips Medical Systems Dmc GmbH (Hamburg, DE) from 2007 to 2024: 19 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 55 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 12 of them its own earlier devices. 54 recalls are linked to its devices.
FDA’s records also spell it “Philips Medical Systems GmbH, Dmc”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Philips Medical Systems Dmc GmbH’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Philips Medical Systems Dmc 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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