FDA applicant
Medyssey Co, Ltd.
FDA records 14 decisions for Medyssey Co, Ltd. (Murray, UT) from 2009 to 2026: 14 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 82 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 13 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Medyssey Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medyssey Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Medyssey Co, Ltd.’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 “Medyssey”
FDA records each applicant name separately; these may or may not be the same firm.