Disposable Trocars

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CiRX Single use electrosurgical pencil with non-coated and coated electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable SpO2 Sensors, Reusable SpO2 Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amydi-med Disposable Non-invasive EEG electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Smart Pain Reliever, Model LT5019

FDA 510(k)

FDA Class 2 ·Neurology

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