INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

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

INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER

Device

EU MDD · Eu Md Class 2a ·Maramco for international trade·On the market·1 country

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

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

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-BP, COROX OTW 85-BP,COROX OTW-S 75-BP,COROX OTW-S 85-BP,COROX OTW-L 75-BP,COROX OTW-L 85-BP

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology