BPA-FREE PIT AND FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

Natus NeuroWorks

FDA 510(k)

FDA Class 2 ·Neurology

Release Laminoplasty Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

FreedomEdge(R) Syringe Infusion System

FDA 510(k)

FDA Class 2 ·General Hospital

Background Pattern Classification [BPc(TM)]

FDA 510(k)

FDA Class 2 ·Neurology

HF 718BD X-Ray System

FDA 510(k)

FDA Class 2 ·Radiology

FreedomEdge Syringe Infusion System

FDA 510(k)

FDA Class 2 ·General Hospital

Unison-C Anterior Cervical Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UltraLase Flexible CO2 Laser Waveguide

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

omni TRAX Active Patient Tracker

FDA 510(k)

FDA Class 2 ·Radiology

Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Proton Positioing and Immobilization Devices

FDA 510(k)

FDA Class 2 ·Radiology

Zmachine Synergy

FDA 510(k)

FDA Class 2 ·Neurology

Livewire Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

iSurg

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery