7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LYTENING 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ESA ARTHROSCOPY CANNULA TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
Dilation Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SABER I/F CAGE
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code MCV·June 6, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 3, 2012
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·September 3, 2010
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