NC TREK OTW CORONARY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REEKROSS FAMILY OR OTW PTA CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTW Takeru PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTA 14 Balloon Dilatation Catheter OTW

FDA 510(k)

FDA Class 2 ·Cardiovascular

EverCrossTM 0.035 OTW PTA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMIDIFIER W/ OR W/OUT ADAPTOR

FDA 510(k)

FDA Class 1 ·Anesthesiology

TWIN-PASS OTW CATHETER, MODEL 5201

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVERCROSS .035 OTW PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Metacross OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

POWERCROSS .018 OTW PTA DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTW MEGALINK SDS BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

Modulight ML6710i Laser and ML-SLA

FDA UDI

Modulight Oyj·06429810677020·The intended use for the ML6710i laser is photo...

Gastrin-17 Advanced

FDA UDI

Biohit Oyj·06419587010359·Gastrin-17 Advanced test is an in vitro micropl...

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·LEAD FIXATION SLEEVE

INFUSION CONTROLLERS WITH OR W/O AIR INLET

Device

EU MDD · Eu Md Class 2a ·BQ Plus Medical Co., Ltd.·On the market·1 country

INFUSION CONTROLLERS WITH OR W/O AIR INLET

Device

EU MDR · Eu Md Class 2a ·Shandong Wuzhou Medical Equipment Co., Ltd.·On the market·3 countries

INFUSION CONTROLLERS WITH OR W/O AIR INLET

Device

EU MDR · Eu Md Class 2a ·Shandong Wuzhou Medical Equipment Co., Ltd.·On the market·3 countries