9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Q-5000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar
FDA UDI
SKLAR CORPORATION·10649111456930·SOLID COLOR SHEET TAPE GRAY
ZIRCONIA IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Bindex BI-2
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 22, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 15, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024