40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC

FDA 510(k)

FDA Class 2 ·General Hospital

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRAZYME(R) ENZYMATIC CLEANER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)

INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

FDA 510(k)

FDA Class 2 ·Orthopedic

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SUNLIGHT OMNISENSE BONE SONOMETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Brain Trauma Assessment Test

FDA classification

FDA Class 2 ·Brain Trauma Assessment Test