23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONIS-PACS
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182820·
PROSOFT
FDA 510(k)
FDA Class 2
·Dental
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 13, 2020
NCIRCLE TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·December 14, 2018
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 9, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
SJM AORTIC VALVED GRAFT
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code LWQ·June 14, 2013
*
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK·Product code KNT·July 19, 2011
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code LWR·February 13, 2013
SIMULUS SEMI-RIGID ANNULOPASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·December 7, 2016
AORTIC AP
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWQ·February 24, 2016
MELODY TRANSCATHER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·January 4, 2019
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 11, 2017
HALL EASY FIT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWQ·June 26, 2017
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 26, 2018
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 28, 2016
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·February 9, 2015
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code LWR·April 9, 2015