FEI 3007644779
Rhinosystems, Inc.
1 American Road, Brooklyn, OH, US
MDR events11All time
Recalls0All time
Registered products6
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
6 product codes
Recent MDR events
11 on file
- NAVAGE NASAL IRRIGATION KITMar 2, 2026InjuryMW5184601
- NAVAGE NOSE CLEANERMar 21, 2025InjuryMW5167950
- NAVAGE NASAL CLEANERAug 16, 2024InjuryMW5158583
- NAVAGE NASAL CAREJul 9, 2024InjuryMW5157153
- NAVAGEJan 19, 2024InjuryMW5150602
- NAVAGE NASAL IRRIGATION SYSTEMDec 8, 2023InjuryMW5149082
- NAVAGE NASAL IRRIGATORNov 29, 2023InjuryMW5148607
- NAVAGEApr 7, 2023InjuryMW5116489
- NAVAGEJan 9, 2023InjuryMW5114241
- NAVAGE NASAL CARE SALINE NASAL IRRIGATIONApr 14, 2022InjuryMW5108998
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3007644779.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 8, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 8, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Feb 8, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Feb 8, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 8, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Feb 8, 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.