Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

OnX Tough

FDA 510(k)

FDA Class 2 ·Dental

ONX Large External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Laser Treatment System, Model: NYX and Grace

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A

FDA 510(k)

FDA Class 2 ·Radiology

21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)

FDA 510(k)

FDA Class 2 ·Radiology

21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

FDA 510(k)

FDA Class 2 ·Radiology

20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)

FDA 510(k)

FDA Class 2 ·Radiology

5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)

FDA 510(k)

FDA Class 2 ·Radiology

21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)

FDA 510(k)

FDA Class 2 ·Radiology

19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A

FDA 510(k)

FDA Class 2 ·Radiology