412 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Calibrators, Ethyl Alcohol

FDA classification
FDA Class 2 ·Calibrators, Ethyl Alcohol

ANNE Pediatric

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANNE One

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANNE Sleep

FDA 510(k)
FDA Class 2 ·Anesthesiology

ANNE Maternal

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ANNE Limb

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANNE One

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANNE Chest

FDA 510(k)
FDA Class 2 ·Cardiovascular

PROVIDER ANNE INFUSER

FDA 510(k)
FDA Class 2 ·General Hospital

ANNE View, Central Hub

FDA 510(k)
FDA Class 2 ·Cardiovascular

CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·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 2 ·Abbott RealTime HBV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas AmpliPrep/Cobas TaqMan CMV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·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 2 ·ROCHE COBAS TAQMAN HBV TESTS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·cobas HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 2 ·COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0