483 results · 41ms · Sources: EU EUDAMED, US FDA

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HCV TEST,VERSION 2.0

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Joint, Temporomandibular, Implant

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

Implant, Dermal, For Aesthetic Use

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

Implant, Cochlear

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

Implant, Cochlear

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

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval
FDA Unclassified ·AQUAFLEX(R) HGP(TM) RIGID GAS PERMEABLE LENSES

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

Implant, Cochlear

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

Implant, Cochlear

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