9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NORTEC CONNECTING TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909118652·REVELATION DIAMOND 801-012C - 5 PACK
ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
FDA 510(k)
FDA Class 2
·Radiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
REPAIR CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·November 23, 2010
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020