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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