16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFT CORNEAL LIGHT SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
DILECTRON URINARY CONDUCTIVITY PROBE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OROSPHERE HCDP
FDA 510(k)
FDA Class 2
·Dental
HUMAPEN ERGO BURGUNDY/CLEAR
FDA Adverse Event
Malfunction
·ELI LILLY AND COMPANY·Product code NSC·June 26, 2014
QUICKFLEX XL LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010
XPOSE 4 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 28, 2012
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
GORE VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 15, 2016
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015