Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTITATIVE EEG ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

EkoSonic Endovascular Device, EKOS+ Endovascular Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eko Low Ejection Fraction Tool (ELEFT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

JO H2O Jelly Original Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DEVETHERM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Parky App

FDA 510(k)

FDA Class 2 ·Neurology

CORE 500 Digital Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORE 500 Digital Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT

FDA 510(k)

FDA Class 2 ·Hematology

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EKOS ultrasound EVD Device, EVD Control Unit

FDA 510(k)

FDA Class 2 ·Neurology