19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERMASHADE VENEER CEMENT
FDA 510(k)
FDA Class 2
·Dental
Flexitron
FDA UDI
Nucletron B.V.·08717213026803·Flexitron Transfer Tube for Metal Needles (29)
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
FDA 510(k)
FDA Class 3
·Orthopedic
MPF ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 7, 2013
INRATIO2
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·May 26, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·August 13, 2008
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
5.5 EXP VERSE SCR 6.0X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 19, 2019
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021