81 results · 24ms · Sources: EU EUDAMED, US FDA

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Novasight Hybrid System

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUSA NXT EXTENDED LENGTH TIP

FDA 510(k)
FDA Unclassified ·Unknown

BI-RADS COMPANION

FDA 510(k)
FDA Class 2 ·Radiology

IMP TM 4.7MM MTX FULL, 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 27, 2024

SYMBIQ SCHANNEL 3/01

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 9, 2014

PROCEDURAL STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·May 17, 2013

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·June 29, 2021

ELECSYS PROLACTIN ASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CFT·March 7, 2018

FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 27, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·June 1, 2021

FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·April 4, 2022

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 28, 2021

IMP TM 4.7MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

FUSION OMNI-TOME

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code KNS·July 19, 2021

IMP TM 6.0MM MTX FULL, 10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 29, 2023

FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·January 11, 2021

FUSION OMNI-TOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·April 29, 2021

FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·May 20, 2021