8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIBA CORNING ACS PROGESTERONE IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010
Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
AUTOMOVE, MODEL AM800
FDA 510(k)
FDA Class 2
·Physical Medicine
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 29, 2013
TRIDENT HEMISPHERICAL CLUSTER 60MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 13, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 14, 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