35 results · 32ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BALLOON APPLICATOR KIT

FDA Adverse Event
Malfunction ·ICAD, INC.·Product code JAD·February 27, 2024

SLDH, DIGITAL TOWER

FDA Adverse Event
Malfunction ·ICAD INC.·Product code LMA·June 26, 2008

SLDM, DIGITAL TOWER

FDA Adverse Event
Malfunction ·ICAD INC.·Product code LMA·June 26, 2008

MAVERICK2 BALLOON CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 2, 2013

MAVERICK2 BALLOON CATHETER

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 2, 2013

MAVERICK2 BALLOON CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 2, 2013

ACCENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY ICAD, INC.·Product code JAD·August 19, 2013

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·May 14, 2014

AXXENT E BX BALLOON APPLICATOR KIT

FDA Adverse Event
Injury ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·December 6, 2017

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·March 7, 2014

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·March 23, 2014

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD INC.·Product code JAD·May 23, 2013

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·January 28, 2019

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Injury ·XOFT, A SUBSIDARY OF ICAD, INC.·Product code JAD·August 27, 2018

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·December 9, 2013

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·May 20, 2016

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDARY OF ICAD, INC.·Product code IYC·May 1, 2017

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Malfunction ·XOFT, A SUBSIDIARY OF ICAD, INC.·Product code JAD·October 28, 2015

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Injury ·XOFT, A SUBSIDARY OF ICAD, INC.·Product code JAD·October 2, 2019

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA Adverse Event
Injury ·XOFT, A SUBSIDARY OF ICAD, INC.·Product code JAD·December 6, 2019