11 results
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26ms
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Sources: EU EUDAMED, US FDA
OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
FDA 510(k)
FDA Class 2
·Anesthesiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517162250·Brigade® Plate, 44mm Lordotic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074447476·INSTRUMENT 8880044 FAS SAS CNTR TRQ 5.5M
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457209744·Internal Hex "Click"
Arthrex®
FDA UDI
ARTHREX, INC.·00888867385382·Bending Iron, Double Ended
SIROLaser Blue
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BREATHING CIRCUIT, BAIN
FDA 510(k)
FDA Class 1
·Anesthesiology
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 13, 2010
ATLAS II VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0
FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·December 19, 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