9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SIM MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209104772·KIT, NAR 5
Endoskeleton TCS Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·June 5, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 29, 2012
PHILIPS 1.5T INTERA
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA INC.·Product code LNH·September 23, 2010
ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
FDA Adverse Event
Malfunction
·TITAN SPINE, LLC·Product code HXX·January 28, 2016
Presource PBDS, Total Knee, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013