9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AALTO LDH ISOENZYME CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788203600·PressON Rivet Inserter
ABR-2000
FDA 510(k)
FDA Class 2
·Neurology
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
NATURLYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·May 4, 2016
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