188 results · 19ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CRT-P Resynchronization Devices

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL SYRINGE

25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY

FDA 510(k)
FDA Class 3 ·Unknown

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID-BRAF KIT

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Puregraft Serene Breast Implant

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·Total Artificial Heart

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporaty Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·KONING BREAST CT (MODEL CBCT1000)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·Syncardia Temporary Total Artificial Heart (TAH-T) system

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·FREEDOM DRIVER SYSTEM

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System