753 results · 40ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

CLEARVIEW HCG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

FDA 510(k)
FDA Class 1 ·Immunology

CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TURBOX FIBRINOGEN

FDA 510(k)
FDA Class 2 ·Hematology

IMMUNOGLOBULINS G

FDA 510(k)
FDA Class 2 ·Immunology

CLEARVIEW STREP A

FDA 510(k)
FDA Class 1 ·Microbiology

TURBOX

FDA 510(k)
FDA Class 1 ·Immunology

STAPHYTECT-OD

FDA 510(k)
FDA Class 1 ·Microbiology

CLEARPLAN

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLEARVIEW HCG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

APOLIPOPROTEIN A1

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CLEARVIEW CHLAMYDIA

FDA 510(k)
FDA Class 1 ·Microbiology

CLEARBLUE EASY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CLEARVIEW HCG SERUM/URINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TURBOX ANTITHROMBIN III

FDA 510(k)
FDA Class 2 ·Hematology

CLEARVIEW HCG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry