32 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sera
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEPAK 15 MONITOR/DEFIBRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·October 15, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 4, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 9, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 3, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·October 12, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 7, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 11, 2020
BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 12, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·May 3, 2019
MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 8, 2019