Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER FREEHAND(R) PTCA CATHETERS

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·REALTIME HCV GENOTYPE II

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK LOMEFLOXACIN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·STORMER Z BALLOON DILATATION/NC STORMER Z BALLOON DILATATION CATHETER

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anbti-HCV Immunoassay

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·THOR PTCA DILATATION CATHETERS WITH 10 MM AND 40 MM LONG BALLOONS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170