ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

DOPPLEX ABILITY

FDA 510(k)

FDA Class 2 ·Cardiovascular

TNI Clear-Guard™ 3 angled breathing filter (1545020)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Unicare (K-UNICARE-USA)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Oxevision Sleep Device

FDA 510(k)

FDA Class 2 ·Neurology

GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT

FDA 510(k)

FDA Class 2 ·Radiology

THE OPTIC BOX CONTACT LENS CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOBCAT DX

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELECTROENCEPHALOGRAPH RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PPV VAPORIZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Anesthesiology

PULSE TIME PRODUCTS LIMITED, PM-3

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

DP240 240 HOUR DOPPLER PROBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORTHOTRON MUSCLE STIMULATOR MK II DC

FDA 510(k)

FDA Class 2 ·Physical Medicine

MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

FDA 510(k)

FDA Class 2 ·Neurology

XVI R5.0

FDA 510(k)

FDA Class 2 ·Radiology