7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PHILLIPS RADIATION MEASURING INSTRUMENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHANTOM PLUS CERAMIC CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BRIGHT GOLD
FDA 510(k)
FDA Class 2
·Dental
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·May 20, 2014
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012
PRODIGY SM STAT LNG LT 16.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 5, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015