450 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k)
FDA Class 2
·Medical Genetics
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
FDA 510(k)
FDA Class 2
·Medical Genetics
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
FDA 510(k)
FDA Class 2
·Medical Genetics
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·BREAST COMPANION SOFTWARE SYSTEM
DETRUSAN 500
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUREFILL OXYGEN COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
FDA 510(k)
FDA Class 2
·Neurology
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys Anti-SARS-CoV-2
FDA 510(k)
FDA Class 2
·Microbiology
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
FDA 510(k)
FDA Class 2
·Microbiology
Flyte
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Flyte
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pelvital System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN PASSION BERRY GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMOGLOBIN ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
FDA 510(k)
FDA Class 2
·Hematology
TROJAN CRYSTAL CLEAR LIQUID
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FOCUS-GHB
FDA 510(k)
FDA Class 2
·Hematology