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

SR-8100 Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

Gas Module 3

FDA 510(k)

FDA Class 2 ·Anesthesiology

V80 Anesthetic Vaporizer (V80)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Safety Blood Collection Set

FDA 510(k)

FDA Class 2 ·General Hospital

BeneVision Central Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

XVbeam2000

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

C5 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TK Intravascular Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

Pressure Therapy System PT1003

FDA 510(k)

FDA Class 2 ·Physical Medicine

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology