11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
R82
FDA UDI
R82 A/S·05707292806260·
PRECISION BLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
Cios Select
FDA 510(k)
FDA Class 2
·Radiology
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Enforcement
Class II
·Terminated·R82 A/S·May 22, 2019
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 23, 2014
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·August 8, 2025
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Recall
Terminated
·Product code INM·March 28, 2019