280 results · 18ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SINOVIAL (SODIUM HYALURONATE 0.8%)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·HYMOVIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNM Urinary)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNOJOYNT

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·TRILURON

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GENVISC 850

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Neuro Cochlear Implant System (NCIS)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SUPARTZ FX

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA TREMOR CONTROL THERAPY SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Protege/Prodigy/Proclaim XR family of SCS IPGs, SCS EPG and SCS Percutaneous Permanent and Trial leads

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC ONE

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PRISMAFLEX TPE2000

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GEL-ONE(R)