16 results · 20ms · Sources: EU EUDAMED, 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