10,000 results · 28ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

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

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V1. 2A PROGRAMMER SOFTWARE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITRIS RESILIA Mitral Valve

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER AND MODEL 3180-R RECEIVER SOFTWARE (VERS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit

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

FDA Pre-Market Approval
FDA Class 3 ·ANTHEM, ANTHEM RF, FRONTIER, FRONTIER II

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Saline-Filled and Spectrum Breast Implants

Lens, Intraocular, Phakic

FDA Pre-Market Approval
FDA Class 3 ·Visian Implantable Collamer Lens for Myopia

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis, Models 305, 310

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS/ISOFLEX S/ISOFLEX P/ISOFELX OPTIM FAMILIES OF LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RIATA DEFIBRILLATION LEADS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY PACEMAKERS

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM OR CABLE MODIFICATION

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·TRANSCYTE, HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·META III MODEL 1206,1206E,1206M PACING SYSTEMS