30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAVI APPLICATOR KIT
FDA 510(k)
FDA Class 2
·Radiology
BABY DOPPLEX 4000 (BD4000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016
IPC® STYLUS TRANSNASAL BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·February 6, 2015
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code ERL·June 19, 2015
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2016
XPS® BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·September 8, 2017
ACCY EF201 IPC FOOT CONTROL ROHS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·September 9, 2014
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code EQJ·June 17, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 9, 2011
BOSTON SCIENTIFIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQX·July 10, 2008
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 29, 2016
XOM UNKNOWN ENDO
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code EQJ·May 8, 2015
XPS® HANDPIECE - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·November 8, 2016
IPC® FOOTPEDAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 1, 2016
XPS® HANDPIECE - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·October 17, 2017
INVICTUS SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025