10,000 results · 106ms · Sources: EU EUDAMED, US FDA

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Evolut PRO+ System and Medtronic Evolut FX System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY CORONARY STENT SYSTEMS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSIGHT READER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON -TB GOLD

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Add-On 10 CE IVD

Basic UDI-DI
EU IVDD · Eu Ivd General ·Molzym GmbH & Co.KG·1 device

Add-On 10 CE IVD

Basic UDI-DI
EU IVDD · Eu Ivd General ·Molzym GmbH & Co.KG·1 device

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy