7 results
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17ms
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Sources: EU EUDAMED, US FDA
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
FDA 510(k)
FDA Class 1
·Microbiology
SALINE WOUND WASH
FDA 510(k)
FDA Unclassified
·Unknown
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·January 14, 2013
PUMP MMT-712LNAS PRDGM INS SK EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·November 24, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
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