15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
FDA 510(k)
FDA Class 2
·General Hospital
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045425·Barrel Shaver, 9mm
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045432·Barrel Sizer, 9mm
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·May 15, 2013
CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·September 24, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 24, 2011
BD INTIMA-II
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 8, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·August 17, 2023
BD INTIMA-II
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 8, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·April 8, 2025
TI-SU03 GC
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
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