12 results
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26ms
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Sources: EU EUDAMED, US FDA
LABCER FIBRINOGEN ASSAY KIT & CALIBR.
FDA 510(k)
FDA Class 2
·Hematology
ARx SAI
FDA UDI
Life Spine, Inc.·00190837190613·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837189143·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173678·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837173074·
CENTRICITY CARDIO IMAGING
FDA 510(k)
FDA Class 2
·Radiology
Venture 0.014 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DUROM ACETABULAR COMPONENT 56/50 CODE P
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 2, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
SUPER POLIGRIP (VARIANT UNK)
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·August 16, 2010
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
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