FDA applicant
Oemedic International, Inc.
FDA records 2 decisions for Oemedic International, Inc. (Littleton, CO) in 2002: 2 510(k) clearances. All are in product code BTM (Ventilator, Emergency, Manual (Resuscitator)). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oemedic International, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Oemedic International, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Oemedic International, 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) Report