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