QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW

FDA 510(k)

FDA Class 2 ·Radiology

QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)

FDA 510(k)

FDA Class 2 ·Radiology

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TSI WILLEN-REICH NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR

FDA 510(k)

FDA Class 2 ·Radiology

TONOPORT VI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Wireless Smart Gluco-Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tisuthes e-PTFE Surgical Patch

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASC-952 PHYSIOLOGICAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOLAB AMPLIFIER MODULE (CAM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPLAY MONITOR (MODEL 78301A)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON

FDA 510(k)

FDA Class 2 ·Cardiovascular

EP AMP, MODEL #901

FDA 510(k)

FDA Class 2 ·Cardiovascular

GO-CLEAN

FDA 510(k)

FDA Class 2 ·General Hospital