AHI System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AHI System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analytic for Hemodynamic Instability (AHI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adjunctive Hemodynamic Indicator With Decision Point

FDA classification

FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point

ARTHREX TENODESIS FAMILY

FDA 510(k)

FDA Class 2 ·Orthopedic

Nd: YAG Laser Therapy System (QN-1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXI-Q DV AND DVR AUTO-INJECTORS

FDA 510(k)

FDA Class 2 ·General Hospital

QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)

FDA 510(k)

FDA Class 2 ·Radiology

MITEK MINI ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MITEK ABSORBABLE ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

tremoFlo C-100 Airwave Oscillometry System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Resmon PRO FULL

FDA 510(k)

FDA Class 2 ·Anesthesiology

PulmoScan

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERICHEK BICARB PH REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABSORBALBE ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

tremoflo C2 Airwave Oscillometry System

FDA 510(k)

FDA Class 2 ·Anesthesiology

SERIM(TM) BICARB PH REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCANLISA HUMAN CRP ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

FibriCheck

FDA 510(k)

FDA Class 2 ·Cardiovascular