7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
C.N.V.T.
FDA 510(k)
FDA Class 1
·Microbiology
HRK-123 KNEE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Gmate SMART Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 30, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 26, 2012
CNS-9700
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORP·Product code MHX·June 15, 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