Checkme Pro Health Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultrasonic Doppler (Model YM-2T8)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RADIAL ARTERY COMPRESSION TOURNIQUET

FDA 510(k)

FDA Class 2 ·Cardiovascular

DURADIAGNOST

FDA 510(k)

FDA Class 2 ·Radiology

DORA Disposable A.V. Fistula Needle Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Biliary Pancreaticobiliary Scope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Injectable Root Canal Bioceramic Sealer (i-MTA SP)

FDA 510(k)

FDA Class 2 ·Dental

Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

uPMR 790

FDA 510(k)

FDA Class 2 ·Radiology

Powered Wheelchair (NXN20-205, NXN20-205M)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric Breast Pump, model: YM-8166

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)

FDA 510(k)

FDA Class 2 ·Neurology