9,270 results · 24ms · Sources: EU EUDAMED, US FDA

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Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) Assay

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TELIGEN

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·KAINOX A+ ICD LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity™, RHA® 2, RHA® 3, RHA® 4

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFOAM Absorbable Gelatin Sponge

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE Injectable Implant

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·SUPERION INTERSPINOUS SPACER SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SELECTSECURE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS