7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WASHER 500 MICROELISA SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ECHO TYPE 4 CF ANTIGEN
FDA 510(k)
FDA Class 1
·Microbiology
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
FDA 510(k)
FDA Class 2
·Cardiovascular
12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·June 19, 2014
ANIMAS INSULIN INFSUION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 25, 2010
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·December 24, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020