SITZMARKS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTROKIT WITH MAGLINTE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DANBY D.S.P. SYRINGE PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

GUNTHER TULIP VENA CAVA FILTER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBO-FLO PICC

FDA 510(k)

FDA Class 2 ·General Hospital

QMS TOBRAMYCIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ULTRACLONE 05-100 GUINEA PIG RBC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TME Temporary Myocardial Electrode

FDA 510(k)

FDA Class 2 ·Cardiovascular

Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

MS PAED-BABY BODY

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

G7 ACETABULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15

FDA 510(k)

FDA Class 2 ·Anesthesiology

AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)

FDA 510(k)

FDA Class 2 ·Anesthesiology

100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUDICOR CA300/CC100 Analyzer with SDB

FDA 510(k)

FDA Class 2 ·Anesthesiology

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery