Sol-millennium Medical, Inc.
311 S Wacker Drive, Chicago, IL, US
Registered product codes
32 product codes
Recent MDR events
693 on file
- Ever CareJul 27, 2026Malfunction3014312726-2026-00050
- SOL-CAREJul 27, 2026Malfunction3014312726-2026-00046
- SOL-MJul 27, 2026Malfunction3014312726-2026-00052
- SOL-MJul 17, 2026Malfunction3014312726-2026-00045
- MONOJECTJul 8, 2026Malfunction3014312726-2026-00049
- MCKESSONJul 2, 2026Malfunction3014312726-2026-00051
- SOL-MJun 26, 2026Malfunction3014312726-2026-00048
- SOL-MJun 26, 2026Malfunction3014312726-2026-00047
- SOL-CAREJun 25, 2026Malfunction3014312726-2026-00043
- SOL-MJun 19, 2026Malfunction3014312726-2026-00042
Recalls
6 on file
- Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗ - Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗ - Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗ - Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗ - Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗ - Open, ClassifiedSep 6, 2024
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
View FDA record ↗
Compliance history
Matched by FEI 3014312726.
FDA inspections
4 on file
- Voluntary Action Indicated (VAI)May 8, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)May 8, 2025
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 20, 2023
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 20, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 803.50(b)(1)Reporting Information Reasonably Known
121 CFR 803.52(c)(10)Device Available for Evaluation
121 CFR 803.56Submission of Supplement to Individual Report Within One Month
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 803.17(a)(1)Lack of System for Event Evaluations
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
1
- 21 CFR 803.50(b)(1)May 8, 2025
Reporting Information Reasonably Known
- 21 CFR 803.52(c)(10)May 8, 2025
Device Available for Evaluation
- 21 CFR 803.56May 8, 2025
Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.100(a)May 8, 2025
Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Dec 20, 2023
Lack of System for Event Evaluations
- 21 CFR 820.30(i)Dec 20, 2023
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Dec 20, 2023
Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Dec 20, 2023
Records of complaint investigation - UDI
Compliance actions
1 on file
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Oct 29, 2024
80FMI \ NEEDLE, HYPODERMIC, SINGLE LUMEN