DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINEMED

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

FDA 510(k)

FDA Class 2 ·Dental

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPUS RUBELLA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

OPUS(R) TOXO-G TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

OPUS(R) ANTI CMV-M

FDA 510(k)

FDA Class 2 ·Microbiology

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·AFP CONTROL PACK

CONSULTIVA REPORT STATION, MODEL RS-1

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

OPUS GENTAMICIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS PHENYTOIN TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS PHENOBARBITAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS NAPA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS MYOGLOBIN TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology