20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORTEZZA Spinal Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
BI-METRIC HEAD/NECK HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304223004·
ENDOCHOICE WATER BOTTLE CAP SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014
2124215-2011-07237
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code LWS·July 14, 2011
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 11, 2013
BD NANO¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020
PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 5, 2019
BD¿ ULTRA-FINE PEN NEEDLES
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·January 24, 2019
RELION PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·March 25, 2021
BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 27, 2018
6MM X 32G PEN NEEDLE (ULTRAFINE MICRO)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 11, 2021
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2017
GMK-REVISION FEMUR REVISION PS SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 4, 2018
GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 23, 2018
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 18, 2019