10,000 results · 52ms · Sources: EU EUDAMED, US FDA

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 ·PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) 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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos Posterior Chamber Intraocular Lens

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

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

Pulse Generator, Permanent, Implantable

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

Pulse Generator, Permanent, Implantable

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

Pulse Generator, Permanent, Implantable

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

Pulse Generator, Permanent, Implantable

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

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·ColoHealth