Medspira Llc
2718 Summer St NE, Minneapolis, MN, US
Registered product codes
4 product codes
Recent MDR events
6 on file
- MCOMPASS ANORECTAL MANOMETRY CATHETERJun 10, 2024Malfunction19497471
- MCOMPASS ANORECTAL MANOMETRY CATHETEROct 25, 2023Malfunction18002755
- MCOMPASS ANORECTAL MANOMETRY CATHETEROct 10, 2023Malfunction17904707
- MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEMJun 7, 2019MalfunctionMW5087234
- MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETERMar 6, 2019Malfunction8394217
- MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETERMar 6, 2019Malfunction8394218
Compliance history
Matched by FEI 3008414621.
FDA inspections
4 on file
- Voluntary Action Indicated (VAI)Jun 27, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 27, 2025
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 16, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 16, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
14 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design validation - Risk analysis
221 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
221 CFR 820.100(a)Lack of or inadequate procedures
221 CFR 820.198(a)Lack of or inadequate complaint procedures
221 CFR 820.40Procedures not adequately established or maintained
1
- 21 CFR 820.30(g)Jun 27, 2025
Design validation - Risk analysis
- 21 CFR 820.30(i)Jun 27, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Jun 27, 2025
Procedures not adequately established or maintained
- 21 CFR 820.90(a)Jun 27, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jun 27, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jun 27, 2025
Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Jan 16, 2024
Lack of System for Event Evaluations
- 21 CFR 820.30(b)Jan 16, 2024
Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Jan 16, 2024
Design validation - Risk analysis
- 21 CFR 820.30(i)Jan 16, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Jan 16, 2024
Design history file
- 21 CFR 820.90(a)Jan 16, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jan 16, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 16, 2024
Lack of or inadequate complaint procedures
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.