824 results · 26ms · Sources: EU EUDAMED, US FDA

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM & MED EL C40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE

BALL TIP, MODEL #030-188

FDA 510(k)
FDA Class 3 ·Cardiovascular

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED

FDA 510(k)
FDA Class 3 ·Orthopedic

GENERATOR, PULSE, IMPLANTABLE

FDA 510(k)
FDA Class 3 ·Cardiovascular

WEDGE TIP, SMALL, MODEL #030-191

FDA 510(k)
FDA Class 3 ·Cardiovascular

WEDGE TIP, SMALL, MODEL #030-194

FDA 510(k)
FDA Class 3 ·Cardiovascular

BALL TIP, MODEL #030-185

FDA 510(k)
FDA Class 3 ·Cardiovascular

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve0153 Evolut™ R System, Medtronic CoreValve™ Evolut™ PRO System, Medtronic Evolut™ PRO+ System and Med

NOVATHERM

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Injectable Gel

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE® Family of Injectable Gels

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·PERLANE L INJACTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Refyne, Restylane Defyne and Restylane Kysse (injectable gels)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE® Injectable Gels