Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-COREK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-CORE-IGMK PLUS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DiaSorin ETI-EBK PLUS assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-AB-AUK PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DiaSorin ETI-AB-AUK PLUS assay

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

MODEL 430-07 ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR

FDA 510(k)

FDA Class 3 ·Cardiovascular