11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
FDA 510(k)
FDA Class 2
·Orthopedic
VENTRIO
FDA UDI
Davol Inc.·00801741031502·Ventrio ST Hernia Patch, 7.6 cm (3.0"), Circle
Corin TriFit CF Hip Stem
FDA UDI
CORIN LTD·05056139231070·TriFit™ CF Rasp (Size 10)
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169622296·TRAY 2950010 TORQUE MULTIPLIER INSTRUMNT
Athena GTX Device Management Suite (ADMS) Software
FDA UDI
ATHENA GTX, INC.·B3943950010000·Athena GTX Device Management Suite - Android
WU'S POWERED WHEELCHAIR, MAMBO 36X
FDA 510(k)
FDA Class 2
·Physical Medicine
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·February 8, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 6, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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