FDA applicant
Miami Device Solutions, LLC
FDA records 7 decisions for Miami Device Solutions, LLC (Miami, FL) from 2015 to 2018: 7 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 10 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Miami Device Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Miami Device Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Miami Device Solutions, LLC’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) ReportOther applicant names beginning “Miami”
FDA records each applicant name separately; these may or may not be the same firm.