ARK Fentanyl Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Methotrexate Assay

FDA 510(k)

FDA Unclassified ·Unknown

REGIUS SIGMA2

FDA 510(k)

FDA Class 2 ·Radiology

ARK Tramadol Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Rapid Barostat Bag (RBB) Pump and Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AERODR SYSTEM WITH P-21

FDA 510(k)

FDA Class 2 ·Radiology

AEROSYNC FOR AERODR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS UNITEA

FDA 510(k)

FDA Class 2 ·Radiology

V20, V20a, AVSM3 SNF

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIRECT DIGITIZER, REGIUS MODEL 110

FDA 510(k)

FDA Class 2 ·Radiology

ARK EDDP Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PATIENT EXAMINATION GLOVE (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

ACIES

FDA 510(k)

FDA Class 2 ·Radiology

SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PatCom Distal Chip Endoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AERODR SYSTEM WITH P-31

FDA 510(k)

FDA Class 2 ·Radiology

AERODR STITCHING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AERODR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CO PILOT/REGIUS UNITEA

FDA 510(k)

FDA Class 2 ·Radiology

REGUIS SIGMA

FDA 510(k)

FDA Class 2 ·Radiology