4,426 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/LUMAX 540 VR-T DX/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·LINOX SMART SD60/16; SD 65/16; 65/18, 75/18; S60, S65, S75, S DX 65/15, 65/17, T65, TD 65/16, 65/18, VOLTA TA ICR60,65,7
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6
Abbott Rapid Dx International Limited
Authorized representative
🇮🇪 Ireland·5 Manufacturers·4 Devices
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·LeukoStrat CDx FLT3 Mutation Assay
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD'S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D
V7 103108 0005
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V7 103108 0007
Certificate
IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·Cologuard
AKRALAB S.L.U.
Importer
🇪🇸 Spain·8 Manufacturers
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·Cologuard
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·Cologuard
Eurolink Europe Compliance Limited
Authorized representative
🇮🇪 Ireland·35 Manufacturers·252 Devices
MediMark Europe Sarl.
Authorized representative
🇫🇷 France·35 Manufacturers·3394 Devices
JaviTech e.K.
Authorized representative
🇩🇪 Germany·111 Manufacturers·1816 Devices
cobas 8000 cobas ISE MODULE [DOUBLE]
FDA registration
ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany
cobas 8000 cobas ISE MODULE [DOUBLE]
FDA registration
ROCHE DIAGNOSTICS GMBH·78 products·🇩🇪 Germany
Analyzer
FDA registration
Diamond Diagnostics Inc.·78 products·🇭🇺 Hungary