7 results
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18ms
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Sources: EU EUDAMED, US FDA
COAG-A-MATE(R) XC
FDA 510(k)
FDA Class 2
·Hematology
CoaguChek Vantus System
FDA 510(k)
FDA Class 2
·Hematology
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 13, 2014
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code MSS·October 8, 2010
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·December 12, 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