8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DIGITAL SPHYGMOMANOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COPA AMD ANTIMICROBIAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SCREENING COMPUTEO SC-20
FDA 510(k)
FDA Class 2
·Anesthesiology
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020