FEI 1037039
Qed, Inc.
750 ENTERPRISE DR., LEXINGTON, KY, US
MDR events7All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 product codes
Recent MDR events
7 on file
- MAXENON XI 300Sep 5, 2014Malfunction3005775121-2014-00002
- MAXENON XI 300Jun 4, 2014Malfunction1037039-2014-00001
- MAXENON XI 300Apr 23, 2014Malfunction3788106
- MAXENON XI 300-WATT XENON LIGHT SOURCEJan 16, 2014Injury3005775121-2014-00001
- MAXENON XI 300-WATT XENON LIGHT SOURCESep 16, 2013Injury3005775121-2013-00002
- MAXENON XI 300-WATT XENON LIGHT SOURCESep 16, 2013Injury3005775121-2013-00003
- MAXENON XI 300-WATT XENON LIGHT SOURCESep 16, 2013Injury3005775121-2013-00001
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1037039.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Apr 11, 2025
Label to bear a unique device identifier
- 21 CFR 830.300(a)Apr 11, 2025
Devices subject to device identification GUDID data submission requirements.
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.