UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)

FDA 510(k)

FDA Class 2 ·General Hospital

Tiche PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Duracetal

FDA 510(k)

FDA Class 2 ·Dental

OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Labat series Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Clivia series Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Carnation series Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

FDA 510(k)

FDA Class 2 ·Radiology

DEXTER HAND EVALUATION AND THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

HYDROFERA SURGICAL SPEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intense Pulsed Light Treatment System (LK-PT)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Velguard Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery