15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZ-Cover
FDA 510(k)
FDA Class 2
·Radiology
HERO VASCULAR ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
UROSKOP OMNIA
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 27, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 26, 2008
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
ULTRATHANE SUPRAPUBIC CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KOB·August 23, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 17, 2022
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·August 23, 2021
COOK COPE-LOOP CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code LJE·July 21, 2021
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