23 results · 24ms · Sources: EU EUDAMED, 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

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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