165 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
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
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE