Bio-med Devices, Inc.
61 SOUNDVIEW RD, GUILFORD, CT, US
Registered product codes
6 product codes
Recent MDR events
105 on file
- BIO-MED DEVICES TV100Jul 14, 2026Malfunction25811769
- BIO-MED DEVICES TV100Jul 14, 2026Malfunction25811770
- BIO-MED DEVICES TV100Jul 14, 2026Malfunction25811856
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134913
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134914
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134938
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134956
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134957
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134984
- BIO-MED DEVICES, INC.May 11, 2026Malfunction25134986
Recalls
9 on file
- TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 29, 2005
Adapters may be occluded potentially preventing inhalation
View FDA record ↗ - TerminatedJan 6, 2004
Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
View FDA record ↗
Compliance history
Matched by FEI 3003952420.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 20, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 20, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.184(f)Dec 20, 2024
DHR - UDI not included
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.