10,000 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
QDR
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code KGI·December 22, 2017
HOLOGIC QDR
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code KGI·January 18, 2011
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
FDA 510(k)
FDA Class 2
·Radiology
QDR BONE DENSITOMETER
FDA Adverse Event
Other
·HOLOGIC, INC.·Product code KGI·July 1, 2008
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
FDA 510(k)
FDA Class 2
·Radiology
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
FDA 510(k)
FDA Class 2
·Radiology
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
FDA 510(k)
FDA Class 2
·Radiology
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
FDA 510(k)
FDA Class 2
·Radiology
TACTISYS¿ MAIN ADAPTER ASSEMBLY
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code OAE·December 13, 2021
Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·April 7, 2009
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 26, 2019