8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
ELMED
FDA UDI
ELMED INCORPORATED·00842180160163·Sachs Suction Tube, w/ Finger Valve and Obturat...
Schoelly Cystoscopes/Hysteroscopes and Accessories
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KJ Mini Implant System
FDA 510(k)
FDA Class 2
·Dental
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 16, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 14, 2014
BACT/ALERT BPA
FDA Adverse Event
Death
·BIOMERIEUX, INC.·Product code MDB·July 25, 2013