SPIROTEQ

FDA 510(k)

FDA Class 2 ·Anesthesiology

Enobio Wireless EEG

FDA 510(k)

FDA Class 2 ·Neurology

BIS™ Advance Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

BIS EEG MONITOR VIEW

FDA 510(k)

FDA Class 2 ·Neurology

BIS CLICK SENSOR/CABLE

FDA 510(k)

FDA Class 2 ·Neurology

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3MP GRAYSCAKE LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLARIS 100/200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

3MP COLOR LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Flowtron DVT5 Small Calf Garment

FDA 510(k)

FDA Class 2 ·Cardiovascular

Haemostasis Clips

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)

FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PERSEUS A500

FDA 510(k)

FDA Class 2 ·Anesthesiology