11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FUSE ™ SPINAL SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169245501·CAGE 2881224 FUSE 12MM X 24MM 8DEG
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881224220·dentaform® Snap Band, Tooth 36, Size 24/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881224180·dentaform® Snap Band, Tooth 36, Size 24/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011881224000·dentaform® Snap Band, Tooth 36, Size 24
METER, FLOW, PEAK
FDA 510(k)
FDA Class 2
·Anesthesiology
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF·Product code LXH·October 6, 2010
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·December 20, 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