FDA applicant
Acu Med, Inc.
FDA records 48 decisions for Acu Med, Inc. (Beaverton, OR) from 1990 to 2002: 48 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 14 predicates, 2 of them its own earlier devices. 26 recalls are linked to its devices.
FDA’s records also spell it “Acu-Med, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acu Med, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Acu Med, Inc. since 2007.
Recalls per year
2in 2014
Class I Class II/III not classified
Planning a device like Acu Med, 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