570 results · 19ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SLM-2 SILICONE UV-ABSORBING IOL

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE® Transcarotid Stent System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX Injectable Gel

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Solesta Injectable Gel

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE Injectable Implant

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK & ACCULINK CAROTID STENT SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·SOLESTA

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Precise Nitinol Stent Systems

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL