9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029106·PESSARY, OVAL #8, W/SUPPORT, 3.75”
HEALTH BUDDY APPLIANCE
FDA 510(k)
FDA Class 2
·Cardiovascular
PEARL DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 22, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·December 30, 2015