Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

DPZ Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

Terragene Chemdye

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)

FDA Class 2 ·General Hospital

Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

FDA 510(k)

FDA Class 2 ·Dental

Stimulator, Muscle, Powered, Dental

FDA classification

FDA Class 2 ·Stimulator, Muscle, Powered, Dental

Finiff System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Quantib Brain 1

FDA 510(k)

FDA Class 2 ·Radiology

Test Reagents For Ethyl Alcohol

FDA classification

FDA Class 2 ·Test Reagents For Ethyl Alcohol

Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders

FDA classification

FDA Class 2 ·Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders