Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZS3 Ultrasound System, z.one pro Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8

FDA 510(k)

FDA Class 2 ·Radiology

JUSHA-C23C LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Single-use Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hair Removal Device, Model(s): R2815-G Pro, R2815-G

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Magnetic Reasonance Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Essence 55S Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

BEYONDIMAGE WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Multistage Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Wrist - Type Fully Automatic Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Devon 24

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATACOM DC PACS

FDA 510(k)

FDA Class 2 ·Radiology

iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry