9 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHILIPS COMPUTED RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471149816·K-WIRE - DOUBLE TROCAR FULLY THREADED 1.2mm DIA...
PHILIPS MULTILEAF COLLIMATOR (MLC)
FDA 510(k)
FDA Class 2
·Radiology
SPAND-GEL GRANULATED GEL
FDA 510(k)
FDA Class 1
·General Hospital
SPIROBAC FILTER REINF MEMBRANE
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code CAH·August 1, 2012
PLM A+ SPANISH DEVIC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 5, 2014
DRAGER
FDA Adverse Event
Injury
·DRAGER MEDICAL INC.·Product code CBK·February 12, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 21, 2010
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