FDA applicant
W.O.M. World of Medicine GmbH
FDA records 41 decisions for W.O.M. World of Medicine GmbH (Berlin, DE) from 1992 to 2025: 41 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and HIG (Insufflator, Hysteroscopic). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 63 predicates, 35 of them its own earlier devices. 10 recalls are linked to its devices.
FDA’s records also spell it “W.O.M. World of Medicine AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided W.O.M. World of Medicine GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like W.O.M. World of Medicine 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