FDA applicant
Southeastern Medical Diagnostics, Inc.
FDA records 1 decision for Southeastern Medical Diagnostics, Inc. (Greensboro, NC) in 1993: 1 510(k) clearance. All are in product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic). 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 Southeastern Medical Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Southeastern Medical Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Southeastern Medical Diagnostics, 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 “Southeastern”
FDA records each applicant name separately; these may or may not be the same firm.