MAX IT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPUS TM T-UPTAKE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS DIGITOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CIBA CORNING ACS CKMB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

XPLAN 2.1

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KENDALL SHERIDAN CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOPHER AND BIERER OVUM FORCEPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

FIREFLY

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACCU-FLO* UNITIZED SHUNT

FDA 510(k)

FDA Class 2 ·Neurology

KATZEN THROMBOLYSIS GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIROYAL BILIARY PREMOUNTED STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACTIV VARNISH

FDA 510(k)

FDA Class 2 ·Dental

YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cytrellis Dermal Micro-Coring System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DANBY-DCR VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery