10,000 results
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56ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH. LTD./HUNTINGTON·Product code HQL·February 4, 2013
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH. LTD./HUNTINGTON·Product code HQL·February 4, 2013
THORATEC® HEARTMATE 3® LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·April 28, 2026
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 12, 2014
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·June 10, 2015
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·January 29, 2014
MONACO
FDA Adverse Event
Malfunction
·IMPAC MEDICAL SYSTEMS, INC.·Product code MUJ·December 8, 2016
OCENTRA MASTERPLAN
FDA Adverse Event
Malfunction
·NUCLETRON, B.V.·Product code MUJ·January 5, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
ECLIPSE
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code MUJ·January 31, 2012
IPLAN RT DOSE
FDA Adverse Event
Other
·BRAINLAB AG·Product code MUJ·March 8, 2012
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA Adverse Event
ACCURAY, INC.·Product code MUJ·February 18, 2009
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA Adverse Event
Malfunction
·ACCURAY, INCORPORATED·Product code MUJ·March 23, 2009
9.2 PINNACLE3 SW
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MUJ·May 9, 2014
BRACHYVISION
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS, INC.·Product code MUJ·May 27, 2014