9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NuVasive
FDA UDI
Nuvasive, Inc.·00887517385536·Universal Rasp, Serrated Thoracic
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028494·3M™ Unitek™ Stainless Steel First Permanent Mol...
SPERMCHECK FERTILITY
FDA 510(k)
FDA Class 2
·Hematology
MICHIGAN CRANIAL RESHAPING ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
4.5MM CORTEX SCREW 38MM
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HWC·June 27, 2014
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·January 7, 2013
LIGAMAX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 16, 2010
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