10,000 results · 35ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval
FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5 System and Impella Ventricular Support Sustems

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella CP/LD, Impella 2.5/5.0

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Automated Impella Controller

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Automated Impella Controller

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·IMPELLA 2.5 SYSTEM

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Automated Impella Controller

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ER-ICA MONOCLONAL

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DA+C & DA+T SERIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C SERIES PULSE GENERATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+C & T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VITATRON DA+ C & T SERIES