FDA applicant
Bomed Medical Mfg., Ltd.
FDA records 2 decisions for Bomed Medical Mfg., Ltd. (Irvine, CA) from 1989 to 1990: 2 510(k) clearances. All are in product code DSB (Plethysmograph, Impedance). 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 Bomed Medical Mfg., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bomed Medical Mfg., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bomed Medical Mfg., Ltd.’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 “Bomed”
FDA records each applicant name separately; these may or may not be the same firm.