5 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.
FDA Enforcement
Class I
·Terminated·MCKESSON TECHNOLOGIES INC.·March 12, 2014
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
FDA Enforcement
Class I
·Terminated·OraSure Technologies, Inc.·August 24, 2016
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019