21 results · 36ms · Sources: EU EUDAMED, US FDA

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FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM

FDA 510(k)
FDA Class 1 ·Radiology

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

FDA 510(k)
FDA Class 2 ·Radiology

LASERTX - DIODE LASER & DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·June 23, 2014

ANEURX AAADVANTAGE STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 17, 2010

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·February 8, 2013

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

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

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·June 14, 2016

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

DURAN ANCORE RING

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

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025