Source: Third-party index, not matched to FDA. This record came from a third-party Form 483 index rather than from FDA directly, and we have not been able to match it to a document or an inspection FDA publishes. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3011171776.
Observations3
Issue DateMarch 04, 2025
StatusNo Warning Letter
Related Inspections0
Establishment Details
Firm
Saphena Medical, Inc.
Location
Jacksonville, Florida, United States
FEI Number
3011171776
Product Type
Devices
Issue Date
March 04, 2025
Country
United States
Inspection History
We hold no FDA inspection matched to this establishment.