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

Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·NEEDLE ZAP (R)

Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·NEEDLE ZAP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000XP CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·IMX PSAS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·RayOne EMV

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX HAVAB

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene Cryotherapy Device

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS and Micra TPS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX(R) HAVAB

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval
FDA Class 2 ·IMX TACROLIMUS II

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX PSA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX(R) HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX(R) HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX(R) HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·IMX HAVAB-M

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval
FDA Class 2 ·IMX TACROLIMUS II