WR3500 AND WR3600 SERIES RECORDERS

FDA 510(k)

FDA Class 1 ·Cardiovascular

STAR CALC

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELECTONE/PA RECHARGEABLE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

INTEGRITI PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zap-X Radiosurgery System

FDA 510(k)

FDA Class 2 ·Radiology

8X-10-6XXX Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

FDA 510(k)

FDA Class 2 ·Neurology

PREMIER ASP/CD RECHARGEABLE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SURGEN VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

INWAVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

C900 X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000

FDA 510(k)

FDA Class 1 ·Physical Medicine

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2

INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW MORPHINE URINE CASSETTE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry