1,525 results · 20ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 2 LV-1 & IS-1, EASYTRAK 3 LV-1 & IS-1, AND ACUITY SPIRAL LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 2 LV-1 AND IS-1 LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ELITE &II, MINUET,PREVA PREVA D PRODIGY SYNERGYST II,THERA &I, , VITATRON LEGACY, VITATRON LEGAACY,REVEAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ITREL II SPINAL CORD STIMULATION SYSTE, INCLUDING A BIFURCATED Y-EXTENSION

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Avitene® Microfibrillar Collagen Hemostat

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DISCOVERY/MERIDIAN

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 3 PACING LEAD

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Series Product Line/Artifical Urinary Sphincter with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I

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

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator

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

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE, 1.3 CC AND 0.3 CC