10 results
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67ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QLAB Advanced Quantification Software
FDA 510(k)
FDA Class 2
·Radiology
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
FDA 510(k)
FDA Class 2
·Cardiovascular
INJECTAFIL
FDA 510(k)
FDA Class 2
·Dental
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·June 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 20, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018