1,008 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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MEDCOMP ASH SPLIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAPID IMMUNO-ASSAY SYS
FDA 510(k)
FDA Class 2
·Hematology
GENERAL DIAGNOSTICS PLATELET ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDCOMP REPAIR KIT, MODEL ASPCRPK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
FDA 510(k)
FDA Class 2
·Immunology
RETRO REPAIR KIT, MODEL PRRK5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CPR C-SECTION DELIVERY PACK
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
C-SECTION TRAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LABOR AND DELIVERY TRAY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QAB2A IGM ELISA KIT
FDA 510(k)
FDA Class 2
·Immunology
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·THE NORMALINE KIT
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·THE NORMALINE KIT
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Abbott RealTime HCV GT II