5 results
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19ms
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Sources: EU EUDAMED, US FDA
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
FDA Enforcement
Class II
·Terminated·Mizuho America, Inc.·December 4, 2013
Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
FDA Enforcement
Class II
·Terminated·Mizuho America, Inc.·December 4, 2013
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 27, 2018
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 27, 2018
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 27, 2013