TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VitalDetect

FDA 510(k)

FDA Class 2 ·General Hospital

CANVAS N-VAS-D 2.0

FDA 510(k)

FDA Class 2 ·Radiology

RADIOVISION

FDA 510(k)

FDA Class 2 ·Radiology

MULTISTIM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES

FDA 510(k)

FDA Class 2 ·Anesthesiology

PAJUNK MODULAR HANDLE INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MUSCLE IMAGING SYSTEM (MIS)

FDA 510(k)

FDA Class 2 ·Radiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 2 ·IMX AND AXSYM PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) PSA*

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV/COBAS AMPLICOR HCV TEST

RETROGRADE KNIFE

FDA 510(k)

FDA Class 2 ·Orthopedic

PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROBE KNIFE

FDA 510(k)

FDA Class 2 ·Orthopedic