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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Emblem S-ICD Programmer - Plexus SMT Mfg. Line

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·FLEX MOBILE BEARING KNEE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·DISPOSABLE FALOPE-RING BANK APPLICATOR KITS

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini IPG

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·Optimizer Smart System and Optimizer Smart Mini System

Embolization Agent, Vascular

FDA Pre-Market Approval
FDA Class 3 ·LAVA® Liquid Embolic System (LAVA LES)

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIhome Remote Patient Monitoring System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart IPG

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·Optimizer Smart System (IPG)