MODEL J-5 MVO-MONITOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGOIRITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

WRIST FUSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL AND HEMI SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DVO EXTENDED ARTICULATION HUMERAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

VOLAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LED Curing Light (C01-X, C02-X)

FDA 510(k)

FDA Class 2 ·Dental

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Endoscopic Cutter Stapler and Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

FDA 510(k)

FDA Class 2 ·General Hospital

HASKEL CPR

FDA 510(k)

FDA Class 2 ·Cardiovascular