Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electronic Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

Doppler FHR Detector (BF-500D+, BF-560)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

A5 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

TK Safety Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Passport Series Patient Monitors (Including Passport 8, Passport 12)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LED light therapy mask (FM-01, FM-02, FM-03)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vital Signs Monitors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Acclarix AX4 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TK Pre-Filled Normal Saline Flush Syringe

FDA 510(k)

FDA Class 2 ·General Hospital