189 results · 73ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS

Prosthesis, Posterior Spinal Elements

FDA Pre-Market Approval
FDA Class 3 ·TOPS™ System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC-58NBM & PC-58NBZ IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Itrel®, Synergy® and lntellisTM Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris®

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

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System - Attune Revision Tibial Sleeves

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

FDA Pre-Market Approval
AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY XR TORIC

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA