17 results · 28ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PK-175/2,3m Patient Cable, PK-83, 2.5m

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER® LA-15 System

Lipoprotein, Low Density, Removal

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

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK

Lipoprotein, Low Density, Removal

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

Lipoprotein, Low Density, Removal

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

Lipoprotein, Low Density, Removal

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

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 LA-15 System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectris® Spinal Cord St

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).

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System