FDA applicant
Univec, Inc.
FDA records 7 decisions for Univec, Inc. (Garden City, NY) from 1994 to 2002: 7 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and MEG (Syringe, Antistick). Its devices cite 3 predicates, 2 of them its own earlier devices. 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 Univec, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Univec, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Univec, 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