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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·SUPERION INTERSPINOUS SPACER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC