8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHEMMATE(TM) LAMBDA
FDA 510(k)
FDA Class 2
·Immunology
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094614·In-Situ Bender, Right
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
FDA 510(k)
FDA Class 2
·Ophthalmic
POWDER-FREE VINYL GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
LIFECARE PCA 3 V5.06
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·December 9, 2010
TAPERLOC MICROP FMRL 6.0MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBL·July 22, 2014
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT 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.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014