Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION

Posterior Cervical Screw Placement Guide

FDA classification

FDA Class 2 ·Posterior Cervical Screw Placement Guide

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE

Sacroiliac Screw Placement Guide

FDA classification

FDA Class 2 ·Sacroiliac Screw Placement Guide

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

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

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

Acetabular Cup Orientation System

FDA classification

FDA Class 2 ·Acetabular Cup Orientation System

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)