UREA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Diacetyl-Monoxime, Urea Nitrogen

FDA classification

FDA Class 2 ·Diacetyl-Monoxime, Urea Nitrogen

BREEZE C MODEL C (3W), BREEZE C (4W)

FDA 510(k)

FDA Class 2 ·Physical Medicine

U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TD-1035 Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

URight Hemoglobin A1c system, FORA A1c System

FDA 510(k)

FDA Class 2 ·Hematology

Clear-Aligners

FDA 510(k)

FDA Class 2 ·Dental

HIT Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

REFLECTIONS

FDA 510(k)

FDA Class 2 ·Dental

CDB FLIP-SIDE-CLIP BRACKET

FDA 510(k)

FDA Class 2 ·Dental

CDB Self Ligating Bracket 8F

FDA 510(k)

FDA Class 2 ·Dental

CDB CLIP

FDA 510(k)

FDA Class 2 ·Dental

HDH Treatment Planning System

FDA 510(k)

FDA Class 2 ·Dental

VARIOUS DENTAL IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

WHITE OCULAR PRESSURE RELIEF DEVICE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZIRBLOCK

FDA 510(k)

FDA Class 2 ·Dental

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800

FDA 510(k)

FDA Class 2 ·Hematology

MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

FDA 510(k)

FDA Class 2 ·Hematology

Patient Positioning Devices

FDA 510(k)

FDA Class 2 ·Radiology