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Sources: EU EUDAMED, US FDA
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HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016