GALEO HYDRO AND GALEO HYDRO J-TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SilentZPro 2.0

FDA 510(k)

FDA Class 2 ·Dental

SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Endopath Endoscopic Instruments

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LABOR-DELIVERY STRETCH/BED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)

FDA 510(k)

FDA Class 2 ·General Hospital

CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

FDA 510(k)

FDA Class 2 ·Orthopedic

DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OrthoButton AL

FDA 510(k)

FDA Class 2 ·Orthopedic

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GrayDuck Stent

FDA 510(k)

FDA Class 2 ·Radiology

PELVX DONUT, PELVX CUBE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TENZCARE DUAL-CHANNEL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

TENZCARE MUSCLE STIMULATION ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

INNOFLUOR GENTAMICIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology