FDA applicant
Ulrich GmbH & Co. KG
FDA records 24 decisions for Ulrich GmbH & Co. KG (Ulm, DE) from 2005 to 2025: 24 510(k) clearances. Most are in product codes IZQ (Injector, Contrast Medium, Automatic) and MQP (Spinal Vertebral Body Replacement Device). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 69 predicates, 13 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ulrich GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Ulrich GmbH & Co. KG’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 “Ulrich”
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