96 results · 42ms · Sources: EU EUDAMED, US FDA

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Panoramic Oxygen Mask (POM)

FDA 510(k)
FDA Class 2 ·Anesthesiology

MICROPLEX COIL SYSTEM- COSMOS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME

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

UTS PRECURVED ULTRA TAPER SPHINCTEROTOME

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

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022

AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·April 18, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2011

SWAN-GANZ BIPOLAR PACING CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·September 19, 2008

UTS PRECURVED ULTRA TAPER SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·November 23, 2020

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·December 31, 2020

D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·August 27, 2020

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 20, 2024

TRI-TOME PC PROTECTOR

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code KNS·November 18, 2021

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 21, 2024

COTTON CANNULATOME

FDA Adverse Event
Death ·COOK ENDOSCOPY·Product code KNS·October 14, 2021

D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·November 17, 2021

TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code KNS·December 9, 2021

TRI-TOME PC PROTECTOR

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code KNS·July 12, 2021