8 results
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25ms
·
Sources: EU EUDAMED, US FDA
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INION BIORESTORE
FDA 510(k)
FDA Class 2
·Orthopedic
CHOLESTEROL REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·December 12, 2012
QUICKFLASH RADIAL ARTERY CATHETERIZATION SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL·Product code DQX·September 30, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
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