3,708 results · 28ms · Sources: EU EUDAMED, US FDA

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HCV TEST V2.0

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·CLEAREAD DETECT

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval
FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR HCV TEST, V2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

Test, Time, Prothrombin

FDA classification
FDA Class 2 ·Test, Time, Prothrombin

Assay, Glutathione Reductase

FDA classification
FDA Class 2 ·Assay, Glutathione Reductase

Calibrator For Hemoglobin And Hematocrit Measurement

FDA classification
FDA Class 2 ·Calibrator For Hemoglobin And Hematocrit Measurement

Cyanomethemoglobin Reagent And Standard Solution

FDA classification
FDA Class 2 ·Cyanomethemoglobin Reagent And Standard Solution

Warmer, Blood, Non-Electromagnetic Radiation

FDA classification
FDA Class 2 ·Warmer, Blood, Non-Electromagnetic Radiation

Device, General Purpose, Hematology

FDA classification
FDA Class 2 ·Device, General Purpose, Hematology

Assay, Erythropoietin

FDA classification
FDA Class 2 ·Assay, Erythropoietin

Antigen, Antiserum, Control, Antithrombin Iii

FDA classification
FDA Class 2 ·Antigen, Antiserum, Control, Antithrombin Iii

Von Willebrand Factor Assay

FDA classification
FDA Class 2 ·Von Willebrand Factor Assay

Control, Platelet

FDA classification
FDA Class 2 ·Control, Platelet

Semen Analysis Device

FDA classification
FDA Class 2 ·Semen Analysis Device

Instrument, Hematocrit, Automated

FDA classification
FDA Class 2 ·Instrument, Hematocrit, Automated