44 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
FDA 510(k)
FDA Class 3
·Cardiovascular
PIONEER CROSSFUSE II IBF/VBR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 21, 2013
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·September 26, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2011
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·May 12, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 25, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 8, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 7, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·August 27, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 24, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 18, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·July 25, 2018
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 12, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 15, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·February 17, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 18, 2021
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 19, 2018
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 10, 2020