Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

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

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HYBRID (PTCA) CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION(TM) UV (VASURFILCON)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) 18K(TM) OVER THE WIRE BALL. CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK(TM) .010 CORONARY DILATATION CATH.

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP (LIST 7A48)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE PSA CATALOG # LKPS1,5)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)