FEI 2435300Initial importer
Vasomedical, Inc.
137 Commercial St Ste 200, Plainview, NY, US
MDR events46All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 product codes
Recent MDR events
46 on file
- EECPMar 3, 2016InjuryMW5060782
- ENCHANCED EXTERNAL COUNTERPULSATIONNov 5, 2007Injury2435300-2007-00002
- ENHANCED EXTERNAL COUNTERPULSATIONJan 11, 2007Injury2435300-2007-00001
- ENHANCED EXTERNAL COUNTERPULSATIONFeb 21, 2006Injury2435300-2006-00002
- ENHANCED EXTERNAL COUNTERPULSATIONFeb 7, 2006Injury2435300-2006-00001
- ENHANCED EXTERNAL COUNTERPULSATIONNov 1, 2005Other2435300-2005-00005
- ENHANCE EXTERNAL COUNTERPULSATINGAug 18, 2005Injury2435300-2005-00004
- ENHANCED EXTERNAL COUNTERPULSATIONApr 21, 2005Death2435300-2005-00002
- ENHANCE EXTERNAL COUNTER PULSATIONApr 19, 2005Injury2435300-2005-00003
- ENHANCED EXTERNAL COUNTERPULSATIONFeb 18, 2005DeathMW1034733
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 2435300.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 6, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 6, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 4.1.5Apr 6, 2026
Control over outsourced processes not proportionate to risk
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.