Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·DIASONICS NMR IMAGING SYSTEM

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·STORMER OVER THE WIRE BALLOON DILATATION CATHETER

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV LEAD SYSTEMS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX ALPHA(TM) .018 CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) TRIO(TM) 14 PTCA CATHETER

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·GYROSCAN(TM)

Discs, Elution

FDA Pre-Market Approval

FDA Class 2 ·AMIKACIN ELUTION DISK FOR AUTOBAC

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER