92 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
FDA 510(k)
FDA Class 2
·Cardiovascular
Harvard RestoreFlow A3,5
FDA UDI
Harvard Dental International GmbH·EHAR70832141·Light cure universal flowable microhybrid compo...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
SMITH & NEPHEW PISTONS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
FDA 510(k)
FDA Class 2
·Radiology
ENDOTRACH TUBE 8229507 CONTACT EMG 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·January 7, 2014
NIM® 3.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·November 29, 2017
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·June 16, 2017
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·December 8, 2017
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·August 30, 2016
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·May 9, 2014
ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 8, 2013
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2017
NIM® 3.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·November 27, 2017
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 6, 2023
ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·November 16, 2015
NIM® 3.0 MAINFRAME
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·April 21, 2016
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·March 11, 2014