FEI 1412854Initial importer
Elmed, Inc.
35 N Brandon Dr, Glendale Heights, IL, US
MDR events16All time
Recalls0All time
Registered products83
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
83 product codes
Recent MDR events
16 on file
- MOGEN CLAMP CIRCUMCISION CLAMPJun 19, 2020InjuryMW5095141
- MILLENNIUM SURGICAL FIBER OPTIC RETRACTORMay 27, 2016Malfunction5684654
- MILLENNIUM SURGICAL FIBER OPTIC RETRACTORMay 26, 2016Malfunction5681349
- DENNIS BIPOLAR SUBMUCOSAL TURBINATE PROBEJun 23, 2006Malfunction730370
- ELMED INCORPORATEDMay 6, 2005MalfunctionMW1035411
- *Jun 15, 2004Other534188
- UNKApr 12, 2001Injury328259
- ELMEDMay 25, 1999OtherMW1016391
- LAPAROSCOPIC CAUTERY HOOKAug 31, 1998Malfunction185285
- GRASPING FORCEPMay 27, 1998MalfunctionMW1013870
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1412854.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
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.