1,245 results · 35ms · Sources: EU EUDAMED, US FDA

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0

Software For Endoscopy Procedure Metrics

FDA classification
FDA Class 2 ·Software For Endoscopy Procedure Metrics

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

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HCV ON CENTAUR CP

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·BAK VISTA INTERBODY FUSION CAGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ST AIA-PACK PA

Surgical Apparel With Material Claims

FDA classification
FDA Class 2 ·Surgical Apparel With Material Claims

Chlorine Meter

FDA classification
FDA Class 2 ·Chlorine Meter

Dental Stereotaxic Instrument

FDA classification
FDA Class 2 ·Dental Stereotaxic Instrument

Pedicle Screw Placement Guide

FDA classification
FDA Class 2 ·Pedicle Screw Placement Guide

Infant Supine Sleep System

FDA classification
FDA Class 2 ·Infant Supine Sleep System

Posterior Cervical Screw Placement Guide

FDA classification
FDA Class 2 ·Posterior Cervical Screw Placement Guide

Dna Genetic Analyzer

FDA classification
FDA Class 2 ·Dna Genetic Analyzer