ACU-SYRINGE W/WO NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

FDA 510(k)

FDA Class 2 ·Cardiovascular

1ST RESPONSE DISPOSABLE MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL APS ALTERNANS PROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

IEC MEDSIGHT AND MEDBRIGHT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAPPHIRE NC

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN

FDA 510(k)

FDA Class 2 ·Neurology

QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF

FDA 510(k)

FDA Class 2 ·Neurology

HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLS (POSTERIOR LUMBAR SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

DAHEDI INSULIN INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30

FDA 510(k)

FDA Class 2 ·Neurology

Test, Sorbent, Fta-Abs

FDA classification

FDA Class 2 ·Test, Sorbent, Fta-Abs

FIM Médical

System producer

🇫🇷 France

Chemiluminescence Immunoassay Analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

FDA classification

FDA Class 2 ·Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Ventilator, Emergency, Manual (Resuscitator)

FDA classification

FDA Class 2 ·Ventilator, Emergency, Manual (Resuscitator)

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450790·

Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450455·

Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res.

FDA UDI

Terumo Cardiovascular Systems Corporation·00699753450479·