10,000 results · 61ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System Ascenda Intrathecal Catheters

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDesign Advanced WaveScan Studio, STAR Excimer Laser System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE TRANSCAROTID STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Simplify Cervical Artificial Disc

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM S-ICD VI Electrode (Lead)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELOTERO BALANCE

Mesh, Surgical, Polymeric

FDA Pre-Market Approval
FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Prosthesis, Spinous Process Spacer/Plate

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

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

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX CERAMIC TOTAL HIP SYSTEM

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER Duct Occluder II