PHARMGUARD TOOLBOX, MODEL G6000782

FDA 510(k)

FDA Class 2 ·General Hospital

PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HepaFat-AI

FDA 510(k)

FDA Class 2 ·Radiology

BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADVANTIV SAFETY I.V. CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

FDA 510(k)

FDA Class 2 ·Neurology

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

VITAL FLOW NASAL CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPOLATOR 50

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC

FDA 510(k)

FDA Class 2 ·Cardiovascular