Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) CONSEPT R-2 NEUTRALIZING & RINSING

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM RGP CONTACT LENSES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,40

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS ORION STEERABLE PTCA BALLOON CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IGEL 67 CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

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

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 ·NATUREVUE CONTACT LENSE

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRON HYDROPHILIC CONTACT LENS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MODEL MFL5000 EXPANSION OF INDICATION RANGE

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP