FDA applicant
Medos International SARL
FDA records 101 decisions for Medos International SARL (Le Locle, CH) from 2010 to 2026: 101 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 392 predicates, 86 of them its own earlier devices. 25 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Medos International Sàrl”, “Medos-International Sarl”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medos International SARL’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Medos International SARL’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 “Medos”
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