10,000 results · 34ms · Sources: EU EUDAMED, US FDA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval
FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS(R) TOTAL KNEE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA/RELIA/SENSIA/VERSA IPGS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug, Lead Adaptor, Sprint Quattro Lead, H

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra Transcatheter Pacing System and Micra AV TPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT/SPRINT QUATTRO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO/SUBCUTANEOUS LEAD

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN CONTINUOUS GLUCOSE SYSTEM, DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/FLEXITIP XL-R

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adaptor/Extender Kit; HV Splitter/Adaptor Kit; Sprint Quattro Lead.

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Liver

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain, Ability, Performa, Stability Quard MRI Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA TREMOR CONTROL THERAPY SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM