ISOFLUX IXZ FLOW REGULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DUET GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GO GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN FRUCTOSAMINE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Molecular Transport Media - MTM

FDA 510(k)

FDA Class 2 ·Microbiology

DUET II GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4

FDA 510(k)

FDA Class 2 ·Physical Medicine

SnapshotNIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InVision™ 1.5 Surgical Theatre

FDA 510(k)

FDA Class 2 ·Radiology

EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech Alteon Modular Dual Mobility (MDM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Direxion and Direxion HI-FLO Torqueable Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMID-VENT HEPA

FDA 510(k)

FDA Class 2 ·Anesthesiology