4 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
FDA Enforcement
Class II
·Terminated·Magellan Diagnostics, Inc.·April 11, 2018
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
FDA Recall
Terminated
·Magellan Diagnostics, Inc.·Product code DOF·January 9, 2018
Penner Manufacturing Transfer Electric Cascade Patient Transfer/Lift System, Models 382000-1 (right entry) and 382000-1L (left entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013