B.R.A.H.M.S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TEMP SCAN

FDA 510(k)

FDA Class 2 ·General Hospital

DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B

FDA 510(k)

FDA Class 2 ·Neurology

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

Lung Nodule Assessment and Comparison Option (LNA)

FDA 510(k)

FDA Class 2 ·Radiology

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

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology