9 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981262·anteriors; shade C1; mould IM6
Symmetry
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482087367·Symmetry® Forceps, Glassman, Ratcheting Handle ...
SpineJack Expansion Kit
FDA 510(k)
FDA Class 2
·Orthopedic
DC NEURO
FDA 510(k)
FDA Class 2
·Radiology
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 27, 2013
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·February 2, 2011
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code FAE·August 5, 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