10 results
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18ms
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Sources: EU EUDAMED, US FDA
METABOLIC SYSTEMS
FDA 510(k)
FDA Class 2
·Physical Medicine
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 ...
FLO-GARD 8000 COMPUTER CONTROL INFUSI
FDA 510(k)
FDA Class 2
·General Hospital
FOX BED MODEL 2001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PINN MAR LIP LNR 32IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 3, 2013
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·February 6, 2014
ADVIA 1650
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS, INC·Product code JGS·November 4, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020