9,662 results · 43ms · Sources: EU EUDAMED, US FDA

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK)

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF SENSOR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 5019 HV SPLITTER/ADAPTOR

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minerva Endometrial Ablation System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Selenia Dimensions / 3Dimensions

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH AND LOMB POLYMACON CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) SYNCHROMED II WELDING PROCESSES MONITORS AND CONTROLS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM