EZMClass II
Dilator, Esophageal (metal Olive) Gastro-urology
Gastroenterology, Urology · 21 CFR 876.5365
MDR events10All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances0All time
Recent MDR events
10 adverse event reports on file
- INTERSTIMSep 18, 2009MalfunctionMedtronic Puerto Rico Operations Co.3004209178-2009-06670
- INTERSTIMAug 3, 2009InjuryMedtronic Puerto Rico Operations Co.3004209178-2009-05336
- INTERSTIM IIMar 3, 2009MalfunctionMedtronic Puerto Rico Operations Co.3004209178-2009-01486
- INTERSTIMMar 3, 2009MalfunctionMedtronic Puerto Rico Operations Co.3004209178-2009-01483
- TRACER METRO DIRECT WIRE GUIDEJan 16, 2004MalfunctionWilson-cook Medical, Inc.1037905-2004-00009
- OLYMPUSJun 24, 2003InjuryKeymed (medical & Industrial Equipment) Ltd.9611174-2003-00001
- OLYMPUSMay 21, 2001InjuryKeymed (medical & Industrial Equipment), Ltd.9611174-2001-00001
- BAKES BILE DUCT DILATOR 3MMJul 2, 1999InjuryAesculap Ag & Co. Kg2916714-1999-00015
- OLYMPUS-KEYMEDOct 17, 1997DeathKeymed (medical & Industrial Equipment) Ltd.9611174-1997-00002
- SAVERY DILATOR 38 FR. 12.8MMJul 23, 1993InjuryWilson - Cook8175
Event type breakdown
Injury5
Malfunction4
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.