2,207 results · 42ms · Sources: EU EUDAMED, US FDA

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Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas TaqMan HBV Test v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV

AI Platform 2.0 (AIP002)

FDA 510(k)
FDA Class 2 ·Radiology

ClariSIGMAM

FDA 510(k)
FDA Class 2 ·Radiology

Ceevra Reveal 3+

FDA 510(k)
FDA Class 2 ·Radiology

syngo.via MI Workflows; Scenium; syngo MBF

FDA 510(k)
FDA Class 2 ·Radiology

Overjet Image Enhancement Assist

FDA 510(k)
FDA Class 2 ·Radiology

Strain AI (SAI001)

FDA 510(k)
FDA Class 2 ·Radiology

Arterys MICA

FDA 510(k)
FDA Class 2 ·Radiology

QIR Suite

FDA 510(k)
FDA Class 2 ·Radiology

breastscape v1.0

FDA 510(k)
FDA Class 2 ·Radiology

MEDO-Thyroid

FDA 510(k)
FDA Class 2 ·Radiology

cvi42 Software Application

FDA 510(k)
FDA Class 2 ·Radiology

Neurophet AQUA (V3.1)

FDA 510(k)
FDA Class 2 ·Radiology

Ezra Flash

FDA 510(k)
FDA Class 2 ·Radiology