FEI 3001739169
Global Tv Concepts, Ltd.
6441 Lyons Rd, Coconut Creek, FL, US
MDR events1All time
Recalls0All time
Registered products18
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
18 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3001739169.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 9, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 9, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 4.1.2Feb 9, 2026
Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.4.1Feb 9, 2026
Criteria for the evaluation and selection of suppliers not established
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.