7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PREAMPLIFIER MODEL 113
FDA 510(k)
FDA Class 2
·Neurology
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
GAP PLATE SCREWS
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 30, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012
AC-POWERED PATIENT LIFT
FDA Adverse Event
Injury
·INVACARE·Product code FNG·July 28, 2010
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016