AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

SavDenTM MTA Root Canal Filling Materials

FDA 510(k)

FDA Class 2 ·Dental

Single-use Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Anker Dental Implant System - SB-III, ST and AT series

FDA 510(k)

FDA Class 2 ·Dental

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

FDA 510(k)

FDA Class 2 ·General Hospital

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

FDA 510(k)

FDA Class 2 ·General Hospital

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

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

FDA 510(k)

FDA Class 2 ·Neurology

SterileRight sterilization pouch and roll

FDA 510(k)

FDA Class 2 ·General Hospital

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

FDA 510(k)

FDA Class 2 ·Ophthalmic

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dawn Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infrared Thermometer, Model: IR8807

FDA 510(k)

FDA Class 2 ·General Hospital

Digital Thermometer (Model QT001)

FDA 510(k)

FDA Class 2 ·General Hospital

PK High Tibial Osteotomy Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic