Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 3 Mepi

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 Dermal Fillers

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Artisan Myopia

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·Capsular Tension Ring (CTR) and RingJect

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LED VENTRICULAR PACING LEAD

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford® Partial Knee System

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

FDA Pre-Market Approval

FDA Class 3 ·LCS (R) Total Knee System

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Gevia Deep Brain Stimulation (DBS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

NIDEK DIGITAL KERATOMETER

FDA 510(k)

FDA Class 3 ·Ophthalmic