7 results
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25ms
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Sources: EU EUDAMED, US FDA
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
SURGIMAX PATIENT EXAM GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
SM PLUS SBT/OVAL BALLOON DISSECTOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC·Product code GCJ·May 20, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·November 10, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 28, 2012
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