Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRO MARC LENSES (HYDROPHILIC)

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST V2.0

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PREFLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·NATUREVUE CONTACT LENSE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE (POLYESTER FIBER) SUTURES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMMENDMENT TO E. COLI ASC