63 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGISTAR, INC.
FDA UDI
SURGISTAR, INC.·00878799001573·
MODIFICATION TO GLIDESHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
FDA 510(k)
FDA Class 1
·General Hospital
XENIUM XPM
FDA Adverse Event
Malfunction
·NIPRO CORPORATION *USD*·Product code KDI·February 14, 2013
OPTIVANTAGE WITH PEDESTAL
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·January 13, 2011
AMS ADVANCE MALE SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTM·July 29, 2014
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 2, 2021
RADIFOCUS INTRODUCER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 18, 2022
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·October 9, 2018
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 3, 2020
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·October 30, 2020