29 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.
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
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
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
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Percept PC INS with BrainSense (Model B35200)