Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

FDA 510(k)

FDA Class 2 ·Microbiology

AUTOGROUPER 16C SYS AUTOMATED REAG

FDA 510(k)

FDA Class 2 ·Microbiology

RAPID PLASMA REAGIN CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DADE RPR CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RSR CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VISUWELL REAGIN II

FDA 510(k)

FDA Class 2 ·Microbiology

SI-Restore Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDIN TECH ZIRCONIA-CP10, SS1000

FDA 510(k)

FDA Class 2 ·Dental

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

PROSTHETIC RINGS #4400 MITRAL & 4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BK-N SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORFLO 300 PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT