8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCTIC PREMIER SERIES
FDA 510(k)
FDA Class 1
·Ophthalmic
ENDOCOAGULATOR KRS568(TM) LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FISK HEADREST
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·July 22, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 5, 2013
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 18, 2014
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 3, 2011
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013