DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A

FDA 510(k)

FDA Class 2 ·General Hospital

Stent, Coronary

FDA Pre-Market Approval

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

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

INFUSION CONTROLLERS WITH OR W/O AIR INLET

Device

EU MDR · Eu Md Class 1 ·Wenzhou K.L.F. Medical Plastics Co., Ltd·On the market

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW-L BP LEFT VENTRICULAR PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM (OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL ELUTING STENT SYSTEM (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Soft-Trans

FDA UDI

COOK INCORPORATED·00827002033627·Soft-Trans Guide Catheter

Soft-Trans

FDA UDI

COOK INCORPORATED·00827002327559·Soft-Trans Embryo Transfer Catheter