423 results · 44ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS

FDA Pre-Market Approval
TOUCH® CMC 1 Prosthesis

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLUTION 15ML SAMPLE SIZ

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·SEREINE CLEANER,15ML NEW SAMPLE SIZE

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

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

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Implant, Dermal, For Aesthetic Use

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

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire Upper Airway Stimulation

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP PROCESSOR 2000/3000 SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·INSPIRE II UPPER AIRWAY STIMULATOR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System