8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111213045·TISSUE FCP 3X4 14"
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 26, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 28, 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