23 results · 28ms · Sources: EU EUDAMED, US FDA

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EXPEDIUM SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

JET SYRINGE MODEL-100500

FDA 510(k)
FDA Class 2 ·General Hospital

SWIRLGRAFT VASCULAR ACCESS GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·December 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 31, 2018

SINGLE LOCKING DRILL GUIDE

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code FZX·April 17, 2013

VERSYS FEMORAL STEM BEADED FULLCOAT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code LPH·April 14, 2011

MAVERICK2 MONORAIL PTCA CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·June 18, 2008

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 6, 2023

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·July 25, 2018

OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·December 18, 2023

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·May 29, 2015

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·October 11, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·November 22, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·September 27, 2023

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 13, 2018

RESONANCE STENT SET

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FAD·September 12, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·August 16, 2018

RESONANCE STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FAD·January 22, 2019

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013