FDA applicant
Device Labs, Inc.
FDA records 6 decisions for Device Labs, Inc. (Medway, MA) from 1988 to 1993: 6 510(k) clearances. Most are in product codes LJT (Port & Catheter, Implanted, Subcutaneous…) and KMF (Bandage, Liquid). 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Device Labs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Device Labs, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Device Labs, 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