10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·Barostim System

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval
FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval
FDA Class 3 ·ALERT SYSTEM-COMPANION II

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY, DIAMOND 3, JADE 3, RUBY 3, TOPAZ 3, VITA 2 DDR, C-SERIES, AND T-SERIES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel, Synergy and IntellisM Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF PLUS 60/W AND SPF-PLUS 60/M

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval
FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM