PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOFTLIGHT Q-SWITCHED (ND:YAG) LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VERTOS MEDICAL MILD DEVICE KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

POINT OF USE II SHARPS-A-GATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

FDA 510(k)

FDA Class 2 ·Hematology

RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Mercury® II Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK

FDA 510(k)

FDA Class 2 ·Immunology

INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Flexible Partial Resin

FDA 510(k)

FDA Class 2 ·Dental

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

FDA 510(k)

FDA Class 2 ·Dental

Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Invisalign System

FDA 510(k)

FDA Class 2 ·Dental

EasyCare Tx 2

FDA 510(k)

FDA Class 2 ·Anesthesiology

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular