155 results · 20ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele

HEARTSINE SAMARITAN PAD 350P

FDA 510(k)
FDA Class 3 ·Cardiovascular

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA SR MRI

Cap, Cooling (Infants)

FDA classification
FDA Class 3 ·Cap, Cooling (Infants)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Extended Depth Of Focus Intraocular Lens

FDA classification
FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Artificial Iris

FDA classification
FDA Class 3 ·Artificial Iris

Ophthalmic Sealant

FDA classification
FDA Class 3 ·Ophthalmic Sealant

Phakic Toric Intraocular Lens

FDA classification
FDA Class 3 ·Phakic Toric Intraocular Lens

Intraocular Pressure Lowering Implant

FDA classification
FDA Class 3 ·Intraocular Pressure Lowering Implant

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification
FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA classification
FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)