FDA applicant
GM Dos Reis Industria e Comercio Ltda.
FDA records 18 decisions for GM Dos Reis Industria e Comercio Ltda. (Campinas, BR) from 2020 to 2026: 18 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HTN (Washer, Bolt Nut). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 47 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Gm Dos Reis Industria E Comercio”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided GM Dos Reis Industria e Comercio Ltda.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like GM Dos Reis Industria e Comercio Ltda.’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