Viramed Borrela All-In-One ViraChip Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Paradigm All-Suture Anchor 1.8mm, White/Black #2

FDA 510(k)

FDA Class 2 ·Orthopedic

NeuroStar Advanced Therapy System (All previously cleared models)

FDA 510(k)

FDA Class 2 ·Neurology

SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic

Freedom Total Knee System (All-poly Tibial Plate)

FDA 510(k)

FDA Class 2 ·Orthopedic

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ETI-HA-IGMK PLUS KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX(R) HAVAB

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX HAVAB -M (LIST NUMBER 2263)

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB-M 2.0