FDA applicant
Pro Med Instruments GmbH
FDA records 10 decisions for Pro Med Instruments GmbH (Freiburg, DE) from 2000 to 2024: 10 510(k) clearances. Most are in product codes HBL (Holder, Head, Neurosurgical (Skull Clamp)) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 17 predicates, 8 of them its own earlier devices. 5 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Pro-Med Instruments GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pro Med Instruments GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Pro Med Instruments GmbH’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