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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY ELITE Valve/Delivery System

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MAXIM PFS MODEL 033-301

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationFocus CDx BRCA HRD

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice CDx