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

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

Cufitec Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML

FDA 510(k)

FDA Class 2 ·General Hospital

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

FDA 510(k)

FDA Class 2 ·Radiology

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

FDA 510(k)

FDA Class 2 ·General Hospital

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

FDA 510(k)

FDA Class 2 ·Radiology

TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M

FDA 510(k)

FDA Class 2 ·Cardiovascular

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology