FDA applicant
Bioenvelop Agro, Inc.
FDA records 1 decision for Bioenvelop Agro, Inc. (West Cadwell, NJ) in 2005: 1 510(k) clearance. All are in product code EIE (Dam, Rubber). 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 Bioenvelop Agro, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioenvelop Agro, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bioenvelop Agro, 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