8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EFH-16; S60-K; S 60-J; S 60-S
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EFH-16; S 60-K; S 60-J; S 60-S
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F