65 results · 19ms · Sources: EU EUDAMED, US FDA

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Current+ CD1211-36, CD2211-36, CD1211-36Q, CD2211-36Q; Fortify CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Ass

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS

Agent, Occluding, Vascular, Permanent

FDA classification
FDA Class 3 ·Agent, Occluding, Vascular, Permanent

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA classification
FDA Class 3 ·Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Stent, Central Venous

FDA classification
FDA Class 3 ·Stent, Central Venous

Pulmonary Stent

FDA classification
FDA Class 3 ·Pulmonary Stent

Prosthesis, Posterior Spinal Elements

FDA classification
FDA Class 3 ·Prosthesis, Posterior Spinal Elements

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA classification
FDA Class 3 ·Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Intraocular Pressure Lowering Implant

FDA classification
FDA Class 3 ·Intraocular Pressure Lowering Implant

Bone, Heterograft

FDA classification
FDA Class 3 ·Bone, Heterograft

Ventricular Bypass (Assist) Device

FDA classification
FDA Class 3 ·Ventricular Bypass (Assist) Device

Intracranial Coil-Assist Stent

FDA classification
FDA Class 3 ·Intracranial Coil-Assist Stent

Immunocytochemistry Assay, P16/Ki-67

FDA classification
FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA classification
FDA Class 3 ·System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Immunohistochemistry Assay, Antibody, Met

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met