10,000 results · 40ms · Sources: EU EUDAMED, US FDA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·ACS: CENTAUR AFP IMMUNOASSAY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC (AC1-AC5)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC (AC1-AC5)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2 (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY