10,000 results · 37ms · Sources: EU EUDAMED, US FDA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P & SYNCRA CRT-P

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECAR INTERCEED ABSORBABLE ADHESION BARRIER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Aortic Root Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC INTRAOCULAR LENSES (IOLS)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval
FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis, Model 995, 995SC and 995MS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, RELIA, SENSIA, & VERSA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX NOVUS LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS AND MEDTRONIC CARELINK MONITOR (MODEL 2490H)

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Progel™ Pleural Air Leak Sealant

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

Intrasaccular Flow Disruption Device

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Heart Failure Risk Status (HFRS), Triage-HF

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Medtronic(R) Synchromed(TM) Pump & Infusion System

Pulse Generator, Permanent, Implantable

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER