MISTI Silicone Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPRESSIBLE LIMB SLEEVE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIKINI Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

TruAbutment DS

FDA 510(k)

FDA Class 2 ·Dental

NAMTAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAMTAI

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-100, BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINA SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODEL D DISC FORCE

FDA 510(k)

FDA Class 2 ·Physical Medicine

NAMTAI ELECTRONIC BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINA SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

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

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

DISPOSABLE SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GXR-Series Diagnostic X-Ray System

FDA 510(k)

FDA Class 2 ·Radiology