Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE, RESTYLANE-L, RESTYLANE LYFT, RESTYLANE SILK, PERLANE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Captivia Stent Graft ith the Captivia Delivery System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

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

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) Total Knee System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Injectable Gels

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane, Restylane-L, Perlane, Restylane Lyft with Lidocaine, Restylane Silk

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne, and Restylane Kysse

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Model 4063 Stimulation Lead and 4340 Sensing Lead

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PREPSTAIN SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

S80 IMPLANTABLE CARDIAC PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

Electrical Impedance Spectrometer

FDA classification

FDA Class 3 ·Electrical Impedance Spectrometer

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection