31 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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GOODALL LASER TARGETING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
GAMMA3 AND T2 RECON TARGETING DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
Lithotriptor, Extracorporeal Shock-Wave, Urological
FDA Pre-Market Approval
FDA Class 2
·LITHOTRON ULS
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA Pre-Market Approval
FDA Class 2
·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
ID NOW COVID-19 2.0
FDA 510(k)
FDA Class 2
·Microbiology
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k)
FDA Class 2
·Microbiology
BinaxNOW COVID-19 Ag Card
FDA 510(k)
FDA Class 2
·Microbiology
BD Veritor System for SARS-CoV-2
FDA 510(k)
FDA Class 2
·Microbiology
SCoV-2 Ag Detect Rapid Test
FDA 510(k)
FDA Class 2
·Microbiology
Healgen Rapid COVID-19 Antigen Test
FDA 510(k)
FDA Class 2
·Microbiology
cobas liat SARS-CoV-2 v2 nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k)
FDA Class 2
·Microbiology
Nano-Check COVID-19 Antigen Test
FDA 510(k)
FDA Class 2
·Microbiology
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CUTTING BALLOON
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CUTTING BALLOON MONORAIL
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CUTTING BALLOON
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
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·CUTTING BALLOON ULTRA
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 (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0