9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981292·anteriors; shade C2; mould UL4
CARDIOPNEUMOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FLOW-IT
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EBF·April 10, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·February 2, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·August 5, 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