301 results · 18ms · Sources: EU EUDAMED, US FDA

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·EUFLEXXA (1% Sodium Hyaluronate)

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·CyPass Stent

System, Test, Her-2/Neu, Ihc

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·INSITE HER-2/NEU KIT

System, Test, Her-2/Neu, Ihc

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

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·SPOT-LIGHT HER2 CISH KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·VENTANNA PATHWAY HER-2 (CLONE CB11)

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Her Option Office Cryoablation Therapy System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM