Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM

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

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM Septal Occluder

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, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE L INJECTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTION GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne Injectable Gels

Implant, Cochlear

FDA Pre-Market Approval

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE REFYNE and RESTYLANE DEFYNE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE-L

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM