7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DANTEC MAGNETIC STIMULATOR MAGPRO
FDA 510(k)
FDA Class 2
·Neurology
P2900 X-RAY GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code JWH·January 23, 2013
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
ETHILON NYLON SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·July 10, 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