3,217 results · 28ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CONSTANT FLOW IMPLANTABLE INFUSION PUMP

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR CPSA ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx, FoundationOne Liquid CDx

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue Surgical Adhesive

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·LOTUS Edge Valve System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Synvisc, Synvisc-One

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

FDA Pre-Market Approval
FDA Class 3 ·Cormet Hip Resurfacing System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·TMR Holmium Laser System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·THERMATRX OFFICE THERMOTHERAPY SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·R Series

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·MONOVISC

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® AED G3 Pro

Reherniation Reduction Device

FDA Pre-Market Approval
FDA Class 3 ·Barricaid Annular Closure Device

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FALOPE-RING BAND AND APPLICATOR SYSTEMS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Synvisc and Synvisc-One