7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DETARTRINE Z
FDA 510(k)
FDA Class 1
·Dental
CorSens
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
FDA 510(k)
FDA Class 2
·Hematology
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·September 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD·Product code JOH·July 13, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025