36 results
·
25ms
·
Sources: EU EUDAMED, US FDA
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
FDA 510(k)
FDA Class 2
·Neurology
PAP-CAP
FDA 510(k)
FDA Class 2
·Anesthesiology
POWDERED VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·February 21, 2011
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALUE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2012
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 18, 2013
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·May 9, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 17, 2011
COOK MEDICAL
FDA Adverse Event
Injury
·COOK MEDICAL·Product code DYB·August 7, 2008
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
PRIM SYM SET 2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
PRIM SYM SET2 CL W/FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
PRIM SYM SET 2 CL W/ FILTERTEK VALVE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·April 27, 2022