6 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
IONOSEAL
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·January 30, 2013
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·December 22, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 15, 2014