Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EXCELENS (ATLAFILCON A) CONTACT LENS

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMER, ED. LABS. PTCA

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·DANKER SILICONE LENS (DIMEFOCON-A)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SIGNATURE CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CUSTOMEYES 70L & 79L (LIDOFILCON A&B)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY BALLOON DILATATION CATHETER

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·F C FEMALE CONDOM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·EDAP LT.01 SHOCK WAVE LITHOTRIPTER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

Device, Vascular, For Promoting Embolization

FDA Pre-Market Approval

FDA Class 2 ·MINI BALLOON

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ADAPETTES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·THERASONIC LITHOTRIPSY TREATMENT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MICROSOFTRAC TM (PTCA) CATHETER

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·P.C.A.(TM) TOTAL KNEE SYSTEM

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)