FDA applicant
Seven Harvest Intl. Import & Export
FDA records 7 decisions for Seven Harvest Intl. Import & Export (Mchenry, IL) from 1981 to 1994: 7 510(k) clearances. Most are in product codes BYX (Tubing, Pressure And Accessories) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). 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 Seven Harvest Intl. Import & Export’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Seven Harvest Intl. Import & Export since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Seven Harvest Intl. Import & Export’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 “Seven”
FDA records each applicant name separately; these may or may not be the same firm.