333 results · 52ms · Sources: EU EUDAMED, US FDA

Foam Or Gel Chemical Sterilant/High Level Disinfectant

FDA classification
FDA Class 2 ·Foam Or Gel Chemical Sterilant/High Level Disinfectant

Setmelanotide Eligibility Gene Variant Detection System

FDA classification
FDA Class 2 ·Setmelanotide Eligibility Gene Variant Detection System

C. Difficile Toxin Gene Amplification Assay

FDA classification
FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

Complete Gene Expression Profiling Accessory Reagents

FDA classification
FDA Class 2 ·Complete Gene Expression Profiling Accessory Reagents

Cancer-Related Germline Gene Mutation Detection System

FDA classification
FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

Dissolvable Gel For Preventing Ureteral Stone Migration

FDA classification
FDA Class 2 ·Dissolvable Gel For Preventing Ureteral Stone Migration

Cardiac Allograft Gene Expression Profiling Test System

FDA classification
FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA classification
FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA classification
FDA Class 3 ·Prostrate Cancer Genes Nucleic Acid Amplification Test System

Peripheral Blood Processing Device For Wound Management

FDA classification
FDA Class 2 ·Peripheral Blood Processing Device For Wound Management

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification
FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Absorbable Gel For Intraoperative Use In Spine Surgery

FDA classification
FDA Class 2 ·Absorbable Gel For Intraoperative Use In Spine Surgery

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification
FDA Class 2 ·Autosomal Recessive Carrier Screening Gene Mutation Detection System

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification
FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

High Throughput Dna Sequence Analyzer

FDA classification
FDA Class 2 ·High Throughput Dna Sequence Analyzer

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification
FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification
FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)