FDA applicant
Highland / Marietta, Inc.
FDA records 2 decisions for Highland / Marietta, Inc. (Mentor, OH) in 2001: 2 510(k) clearances. Most are in product codes JOS (Electrode, Electrosurgical) and KNF (Coagulator-Cutter, Endoscopic, Unipolar (And…). 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 Highland / Marietta, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Highland / Marietta, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Highland / Marietta, 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 “Highland”
FDA records each applicant name separately; these may or may not be the same firm.