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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STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STABIL-O-GRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CAREFUSION
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 25, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 16, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 17, 2014
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
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