SCARLET® AC-T Secured Anterior Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

PERLA® TL Posterior Thoraco-lumbar Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

TBS INSIGHT

FDA 510(k)

FDA Class 2 ·Radiology

ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

Pump, Infusion, Pca

FDA classification

FDA Class 2 ·Pump, Infusion, Pca

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)

FDA Class 2 ·Pathology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

FDA 510(k)

FDA Class 2 ·Pathology

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

FDA 510(k)

FDA Class 2 ·Pathology

Sectra Digital Pathology Module (Version 3.3)

FDA 510(k)

FDA Class 2 ·Pathology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

MDPC-8127

FDA 510(k)

FDA Class 2 ·Pathology

HALO AP Dx

FDA 510(k)

FDA Class 2 ·Pathology

NanoZoomer S360MD Slide scanner system

FDA 510(k)

FDA Class 2 ·Pathology

Sectra Digital Pathology Module

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology