12 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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BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
FDA 510(k)
FDA Class 2
·Dental
QCT PRO 3D Volumetric Spine Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM0SS0·Convenience Kit consisting of
- QCT Bone Minera...
QCT PRO 3D Volumetric Spine System
FDA UDI
MINDWAYS SOFTWARE, INC.·B052QCTPROM3SS0·Convenience Kit consisting of
- QCT Bone Miner...
QCT Bone Mineral Density Analysis Software
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIQCTPRO0·The method of Quantitative Computed Tomography ...
ESPE NIMETIC-GRIP
FDA 510(k)
FDA Class 2
·Dental
LS1000 SURGICAL ASPIRATOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 5, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 20, 2012
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·June 25, 2014
ALARIS PUMP MODULE SET NON-VENTED BLOOD SET
FDA Adverse Event
Malfunction
·Product code FPA·June 29, 2021
BD ALARIS¿ LVP BLD180M 15D SS
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 30, 2020
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013