FDA applicant
Medline Industires, Inc.
FDA records 6 decisions for Medline Industires, Inc. (Northfiled, IL) from 2020 to 2024: 6 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medline Industires, LP”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medline Industires, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Medline Industires, 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) ReportOther applicant names beginning “Medline”
FDA records each applicant name separately; these may or may not be the same firm.