FDA applicant
Medline
FDA records 11 decisions for Medline (Mundelein, IL) from 1992 to 2012: 11 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FMQ (Restraint, Protective). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medline’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medline’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.