7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DATA CAMERA
FDA 510(k)
FDA Class 1
·Radiology
MICROPULSE 22U
FDA 510(k)
FDA Class 3
·Cardiovascular
TUMBLER, GENERAL MEDICAL MEDI-PAK
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025