10 results
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18ms
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Sources: EU EUDAMED, US FDA
ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
FDA 510(k)
FDA Class 1
·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 ...
EIA READER MODEL EL301
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 3, 2013
ATLAS II HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010
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