363 results · 19ms · Sources: EU EUDAMED, US FDA

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval
FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·RAPIDSCREEN RS-2000D

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·ICAD SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval
FDA Class 2 ·CERASORB DENTAL

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·LOGICON CARIES DETECTOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·ICAD SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·OMNISENSE 7000S ULTRASOUND BONE SONOMETER

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

FDA Pre-Market Approval
FDA Class 2 ·COBAS TAQMAN HCV TEST VERSION 2.0