KULZER GmbH

Manufacturer

🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Intelligent Ultrasound Limited

Manufacturer

3 Importers·Kiwa Dare B.V. and Kiwa Dare B.V.

Oxipit, UAB

Manufacturer

🇱🇹 Lithuania·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

MEDICA FILTER spol. s r.o.

Manufacturer

🇨🇿 Czechia·3EC International a.s. and 3EC International a.s.

Star Sports Medicine Co., Ltd.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·6 Devices·UDEM Adriatic d.o.o. and TÜV Rheinland LGA Products GmbH

ZHIVAS LTD

Manufacturer

🇧🇬 Bulgaria·3 Basic UDI-DIs·10 Devices·3EC International a.s. and 3EC International a.s.

Terumo Corporation

Manufacturer

🇯🇵 Japan·4 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Chiesi Farmaceutici S.p.A.

Manufacturer

🇮🇹 Italy·ITALCERT SRL and ITALCERT SRL

Meridian Medical d.o.o.

Manufacturer

🇸🇮 Slovenia·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ and SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

MEDI-LINE S.r.l.

Manufacturer

🇮🇹 Italy·12 Basic UDI-DIs·12 Devices·ISTITUTO SUPERIORE DI SANITA' and ISTITUTO SUPERIORE DI SANITA'

Shenzhen MandeLab Co., Ltd.

Manufacturer

🇨🇳 China·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Ascom UMS Srl

Manufacturer

🇮🇹 Italy·KIWA CERMET ITALIA S.P.A. and KIWA CERMET ITALIA S.P.A.

FEops NV

Manufacturer

🇧🇪 Belgium·Kiwa Dare B.V. and Kiwa Dare B.V.

Dear Health Holding Company B.V.

Manufacturer

🇳🇱 Netherlands·Kiwa Dare B.V. and Kiwa Dare B.V.

Heater Cooler B.V.

Manufacturer

🇳🇱 Netherlands·Kiwa Dare B.V. and Kiwa Dare B.V.

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO VIRTUOSO V1.0 SOFTWARE APPLICATION

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

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, S-85, S-95, L-75, L-95, S-75/49, S-85/49, S-95/49, L-75/49, L-85/49 and Sentus ProMRI OTW QP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 AVT CRT-D SYSTEM