ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

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

FDA 510(k)

FDA Class 2 ·Pathology

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

FDA 510(k)

FDA Class 2 ·Pathology

PGDx elio tissue complete

FDA 510(k)

FDA Class 2 ·Pathology

Omics Core

FDA 510(k)

FDA Class 2 ·Pathology

Next Generation Sequencing Based Tumor Profiling Test

FDA classification

FDA Class 2 ·Next Generation Sequencing Based Tumor Profiling Test

PAM 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAM-RL

FDA 510(k)

FDA Class 2 ·Neurology

LNI MGV MEDICAL GAS MIXER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAM CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

P.M. HIP-FEMORAL PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

PBM Hair Therapy Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

Rayvolve LN

FDA 510(k)

FDA Class 2 ·Radiology

Rayvolve PTX-PE

FDA 510(k)

FDA Class 2 ·Radiology

SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TM)

PEM 2400 PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Rayvolve

FDA 510(k)

FDA Class 2 ·Radiology

Rayvolve

FDA 510(k)

FDA Class 2 ·Radiology

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM