MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONE INJECTION GUN (B.I.G.) DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GOLDFINGER DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SQA-iO Sperm Quality Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

KITS AND TRAYS FOR ONE TIME USE ONLY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Cystoject Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

Brainsway Deep (DTMS) System

FDA 510(k)

FDA Class 2 ·Neurology

PERSONAL ECG TRANSMITTER, MODEL CG-6550

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nerivio; Nerivio Infinity

FDA 510(k)

FDA Class 2 ·Neurology

OnGuard2 Chemfort Closed Administration (CADM)

FDA 510(k)

FDA Class 2 ·General Hospital

EVICEL APPLICATION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

AVIAFIT PULSATING LEGBAND

FDA 510(k)

FDA Class 2 ·Cardiovascular

RF-Relief

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

QUANTIX OR VESSEL STABILIZER DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

Watch-PAT300

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lim Precision Steerable TS, Steerable Sheath, Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular