914 results
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44ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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AST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABBOTT HSV EIA
FDA 510(k)
FDA Class 2
·Microbiology
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CREATININE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSYM CYCLOSPORINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FOX PLUS PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
FDA 510(k)
FDA Class 2
·General Hospital
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
Alkaline Phosphatase
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i STAT High Sensitivity Troponin-I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCHITECT STAT High Sensitivity Troponin-I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i STAT High Sensitivity Troponin-I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXIFLO ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMBULATORY ENTERAL NUTRITION PUMP
FDA 510(k)
FDA Class 2
·General Hospital