14 results · 23ms · Sources: EU EUDAMED, US FDA

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ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)

FDA 510(k)
FDA Class 2 ·Dental

APEXCAL

FDA 510(k)
FDA Class 2 ·Dental

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 25, 2013

DEFINIUM 8000

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·December 16, 2010

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·July 17, 2014

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·August 12, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022

CG COMPOSITE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

DURAN ANCORE RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 29, 2021

MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022