2,395 results · 20ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID-BRAF kit

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID REFILL KIT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·C-KIT PHARMDX

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ANCHORING SLEEVE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·ENTERYX PROCEDURE KIT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·C-Kit pharmDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON-TB KIT

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

FDA Pre-Market Approval
FDA Class 3 ·HER2FISH PHARMDX KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID REFILL KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·STYLET ACCESSORY KIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·SenSight™ Extension Kit

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·ENTERYX PROCEDURE KIT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Anchoring Sleeve Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID-BRAF KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CATHETERS, SYNCHROMED, KITS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·ANCHORING SLEEVE KIT

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon Kit