7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MARTIN LEWIS AGAR CSI 3169
FDA 510(k)
FDA Class 2
·Microbiology
THREADED ROD CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PREGELLED DISP. EKG MONITORING ELECT-
FDA 510(k)
FDA Class 2
·Cardiovascular
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·May 5, 2014
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KOC·May 21, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025