FDA applicant
Datex-Ohmeda, Inc.
FDA records 103 decisions for Datex-Ohmeda, Inc. (Madison, WI) from 1998 to 2026: 103 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 134 predicates, 82 of them its own earlier devices. 118 recalls are linked to its devices, 37 Class I.
FDA’s records also spell it “Datex-Ohmeda”, “Datex Ohmeda, Inc.”, “Datex Ohmeda”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Datex-Ohmeda, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
6in 2026
Class I Class II/III not classified
Planning a device like Datex-Ohmeda, Inc.’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 “Datex-Ohmeda”
FDA records each applicant name separately; these may or may not be the same firm.