dS Knee Coil 8ch 1.5T

FDA 510(k)

FDA Class 2 ·Radiology

Multi-Modality Tumor Tracking (MMTT) application

FDA 510(k)

FDA Class 2 ·Radiology

XPERGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Pulse Generator, External Pacemaker, Dual Chamber

FDA classification

FDA Class 2 ·Pulse Generator, External Pacemaker, Dual Chamber

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

Electrode, Pacing And Cardioversion, Temporary, Epicardial

FDA classification

FDA Class 2 ·Electrode, Pacing And Cardioversion, Temporary, Epicardial

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification

FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

FDA classification

FDA Class 2 ·System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

Dna Genetic Analyzer

FDA classification

FDA Class 2 ·Dna Genetic Analyzer