7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CAROTID ARTERY CLAMP W/PILLING LMM
FDA 510(k)
FDA Class 1
·Cardiovascular
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
FDA 510(k)
FDA Class 2
·Dental
XYcor® Expandable Spinal Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
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
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 12, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025