12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEZO TITANIUM CAGE FAMILY
FDA 510(k)
FDA Class 2
·Orthopedic
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 14, 2019
HI-TORQUE POWERTURN
FDA 510(k)
FDA Class 2
·Cardiovascular
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·October 23, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 21, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 7, 2011
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·September 10, 2019
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
FDA Adverse Event
Injury
·COOK INC·Product code DQO·August 10, 2023
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025