8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
CORTISOL SYSTEM BY EIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209112685·
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Picasso Plus, Picasso Lite Plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURFLASH PLUS SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION - KOFU·Product code FOZ·June 6, 2014
MULTIFLEX KNOTLESS FIXATION DEVICE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code MBI·November 27, 2012
CRYSTALENS HD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code NAA·September 29, 2010
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020