MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A

FDA 510(k)

FDA Class 2 ·Radiology

Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HUIBAO BODY FAT SCALE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE THERMOMETER PROBE SHEATHS

FDA 510(k)

FDA Class 2 ·General Hospital

Owgels Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Beauty LED Mask, Model: KFB265

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iHealth Infrared No-Touch Forehead Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

TENS and Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Intrelief

FDA 510(k)

FDA Class 2 ·Neurology

Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)

FDA 510(k)

FDA Class 2 ·Orthopedic

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PC ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

Electronic Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular