2,412 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T
Trilogy Analyzer
FDA registration
JAS Diagnostics/Drew Scientific·7 products·🇺🇸 United States
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF-
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF
Alkaline Picrate, Colorimetry, Creatinine
FDA classification
FDA Class 2
·Alkaline Picrate, Colorimetry, Creatinine
Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
DGS Diagnostics A/S
Authorized representative
🇩🇰 Denmark·4 Manufacturers
Piccolo General Chemistry 6
FDA UDI
ABAXIS, INC.·EABA40000061·The Piccolo® General Chemistry 6 , used with th...
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DEVICE CARELINK ENCORE 29901 PROGRAMMER INCLUDING ACCESSORIES AND REVEAL DX, REVEAL XT (MODEL SW007 V8.0)
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Plexa ProMRI DF- S DX 65/15/17; IIivia 7 DR-T; Inrica 5 DTR-T
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARELINK PATIENT MONITOR 2490G, CARDIOSIGHT READER, CARELINK EXPRESS, REVEAL DX/XT, REVEAL LINQ INSERTABLE CARDIAC MONIT
XL-400
FDA registration
JAS Diagnostics/Drew Scientific·8 products·🇺🇸 United States
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
EDTA Capillary Tubes
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Determine HIV Controls
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Chase Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Abbott Diagnostics Medical Co., Ltd.·1 device
Wire, Guide, Catheter, Exempt
FDA classification
FDA Class 2
·Wire, Guide, Catheter, Exempt
SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer
FDA 510(k)
FDA Class 2
·Orthopedic