8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ESPE VISIO-MOLAR
FDA 510(k)
FDA Class 2
·Dental
PHILIPS External Device Interface Module
FDA UDI
Philips Medizin Systeme Böblingen GmbH·00884838021099·
UNICEM
FDA 510(k)
FDA Class 2
·Dental
MINGOGRAF EEG21
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·November 5, 2012
CALYPSO
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·June 22, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020