15 results · 22ms · Sources: EU EUDAMED, US FDA

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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