FDA applicant
Enterprise Medical Corp.
FDA records 3 decisions for Enterprise Medical Corp. (Greensboro, NC) from 1994 to 1995: 3 510(k) clearances. Most are in product codes FCL (Forceps, Biopsy, Non-Electric) and HET (Laparoscope, Gynecologic (And Accessories)). 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 Enterprise Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Enterprise Medical Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Enterprise Medical Corp.’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