ONE TRAY® Sealed Sterilization Container System

FDA 510(k)

FDA Class 2 ·General Hospital

EZ-TRAXTM Persona Knee Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PFM PROFESSIONAL 7000 SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PUL-TRON 100K PROFESSIONAL SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OFNat Lubricant (L15)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DBEST ONE-STEP HCG SERUM/URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DBEST METHAMPHETAMINES TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

DBEST OPIATES TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DBEST OCCULT BLOOD TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

DBEST COCAINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DBSET MULTIDRUG SCREEN TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID

FDA 510(k)

FDA Class 2 ·Physical Medicine