17 results
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37ms
·
Sources: EU EUDAMED, US FDA
FIBERED PLATINUM COIL, .035 TYPE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYSTEM 90 AND 95
FDA 510(k)
FDA Class 2
·Physical Medicine
FLUID ASPIRATION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 10, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 24, 2014
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013