12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENROUTE Transcarotid Neuroprotection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
FDA 510(k)
FDA Class 2
·Radiology
THERATRON EQUINOX, MODELS 80 CM AND 100 CM
FDA 510(k)
FDA Class 2
·Radiology
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·June 21, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013
GENTLEPOWER LUX CONTRA ANGLE 25LPA
FDA Adverse Event
Injury
·KALTENBACK & VOIGT GMBH·Product code EFA·September 5, 2008
ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·April 23, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·January 27, 2023
ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·May 13, 2023
12MM/130 DEG TI CANN TFNA 70MM - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·August 9, 2017
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023