Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRESOFT SOFT CONTACT LENSE

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER, MODEL MFL5000

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE