20 results · 18ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT

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 ·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·IF4 BOARD FOR THE DUAL PROCESSOR INTERFACE SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·LEAD FIXATION SLEEVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA 2, RHA 3, RHA 4 dermal fillers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Injectable Gel Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Injectable Gel Implants

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·DUROLANE

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 Refyne, Restylane Defyne

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 ·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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 pharmDx