11 results
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19ms
·
Sources: EU EUDAMED, US FDA
COLTOLUX LIGHT METER
FDA 510(k)
FDA Class 2
·Dental
BASE
FDA UDI
Nuvasive, Inc.·00887517700261·BASE Guide, Single F
RESORBABLE BONE SCREW
FDA UDI
Biomet Orthopedics, LLC·00880304416697·
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094201·Rod Template, 300mm
NOVOFINE AUTOCOVER 30G X 8MM
FDA 510(k)
FDA Class 2
·General Hospital
2MP Color LCD Monitor, RadiForce RS240
FDA 510(k)
FDA Class 2
·Radiology
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·February 8, 2013
NKII NONPOROUS REVISION FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·December 7, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2014
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 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