10,000 results · 38ms · Sources: EU EUDAMED, US FDA

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·TAP SYSTEM 2A

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SUREFIX

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval
FDA Class 3 ·ENUCLENE(R) OPHTHALMIC SOLUTION

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (6F)

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA EMINENCE PROSTHESIS SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL SDX

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AV PLUS DX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Contrast Media, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Akreos One-Piece Foldable Acrylic Intraocular Lens

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

FDA Pre-Market Approval
FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS