9 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAKA ANEURYSM CLIP
FDA 510(k)
FDA Class 2
·Neurology
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
FDA 510(k)
FDA Class 2
·Radiology
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 11, 2016
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·February 21, 2013
STRAIGHT MEDIUM ELITE ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·January 21, 2011
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 1, 2014
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016