12 results
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19ms
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Sources: EU EUDAMED, US FDA
VARELISA DSDNA ANTIBODIES (FARR VERSION)
FDA 510(k)
FDA Class 2
·Immunology
Barco
FDA UDI
Barco NV·05415334002975·MDRC-1219 HB TS
CONMED
FDA UDI
Conmed Corporation·10653405005780·ARTHROSCOPY CAMERA DRAPE 5" (12.7 CM) X 96" (24...
hemoFISH Masterpanel
FDA 510(k)
FDA Class 1
·Microbiology
Amplatzer Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ANGIOCATH¿ IV CATHETER 22 G X 1"
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 13, 2017
54 CM BIPOLAR LEAD
FDA Adverse Event
Injury
·GREATBATCH MEDICAL·Product code DTB·February 6, 2013
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·January 6, 2011
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 22, 2014
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FOZ·August 8, 2017
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