9,001 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONSULTA CRT-D & MAXIMO II CRT-D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SECURA DR & MAXIMO II DR & SECURA VR & MAXIMO II VR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC 2490C CARELINK MONITOR 2020A CARDIOSIGHT READER
Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer
🇨🇳 China·55 Basic UDI-DIs·55 Devices·1 Importer·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
S.E. Carburos Metálicos, S.A.
Manufacturer
🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS
A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer
🇮🇹 Italy·55 Basic UDI-DIs·55 Devices·TUV Rheinland Italia SRL, IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·MICRONY PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·META AND TEMPO PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·PARAGON,PHOENIX, MULTILOG, AND SENSORITHM PACEMAKERS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·AURORA/QUADRA, REFLEX, SIMPLEX,META PACEMAKERS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·REGENCY, SENSOLOG III, DIALOG II PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE
GAMA GROUP a.s.
Manufacturer
🇨🇿 Czechia·164 Basic UDI-DIs·200 Devices·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., and ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.
Fin-ceramica faenza spa
Manufacturer
🇮🇹 Italy·71 Basic UDI-DIs·110 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'
BioDomi GmbH
Authorized representative
🇩🇪 Germany·28 Manufacturers·86 Devices
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH