DECOLLATING TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WATER JEL BURN KIT

FDA 510(k)

FDA Not Classified ·Unknown

AUTO FIRST-AID KIT FOR AMERICA

FDA 510(k)

FDA Not Classified ·Unknown

BONE MARROW COLLECTION KIT AND STAND

FDA 510(k)

FDA Class 2 ·Unknown

SURGICAL UTILITY DRAPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FIRST AID SURVIVAL KIT

FDA 510(k)

FDA Not Classified ·Unknown

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

THE STORK OTC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TICK-ATTACK(TM) KIT

FDA 510(k)

FDA Not Classified ·Unknown

FIRST AID KIT, EYE DRESSING

FDA 510(k)

FDA Not Classified ·Unknown

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc

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

FDA Pre-Market Approval

FDA Class 2 ·Cobas HCV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB / Alinity i Anti-HBs

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL