20 results · 41ms · Sources: EU EUDAMED, US FDA

Catheter, Ventricular

FDA classification
FDA Class 2 ·Catheter, Ventricular

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification
FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Test, Immunoassay, Biosensor, Hcg

FDA classification
FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Kit, Typing, Hla-Dqb

FDA classification
FDA Class 2 ·Kit, Typing, Hla-Dqb

Visual, Pregnancy Hcg, Prescription Use

FDA classification
FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

Radioimmunoassay, Corticosterone

FDA classification
FDA Class 1 ·Radioimmunoassay, Corticosterone

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification
FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Mask, Surgical, Eua Authorized

FDA classification
FDA Not Classified ·Mask, Surgical, Eua Authorized

Test, Quantitative, For Hla, Non-Diagnostic

FDA classification
FDA Not Classified ·Test, Quantitative, For Hla, Non-Diagnostic

Test, Qualitative, For Hla, Non-Diagnostic

FDA classification
FDA Unclassified ·Test, Qualitative, For Hla, Non-Diagnostic

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification
FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

Protective Barrier Enclosure With Negative Pressure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure With Negative Pressure

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification
FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Protective Barrier Enclosure

FDA classification
FDA Not Classified ·Protective Barrier Enclosure

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification
FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification
FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Biliary Catheter For Irrigation And Contrast Injection, Exempt

FDA classification
FDA Class 2 ·Biliary Catheter For Irrigation And Contrast Injection, Exempt

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification
FDA Unclassified ·Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification
FDA Unclassified ·Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps