HYGEDENT ALGINATE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

EDOSE

FDA 510(k)

FDA Class 2 ·Radiology

FINGERTIP PULSE OXIMETER, MODEL MD300I

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fractional CO2 Laser Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CanMINI Hand and Foot System

FDA 510(k)

FDA Class 2 ·Orthopedic

Rhinolaryngoscope system

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TRUSCOPE SERIES PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Treatment Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL sapphire ice cooling hair remove device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BPAP System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bronchoscope System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AquaPulse Auxiliary Water Connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WRIST PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non absorbable Surgical Polyester Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Hemostatic Clips

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

FDA 510(k)

FDA Class 2 ·Neurology