460 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
FDA 510(k)
FDA Class 2
·Immunology
HE4 EIA, MODEL: 404-10 US
FDA 510(k)
FDA Class 2
·Immunology
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
FDA 510(k)
FDA Class 2
·Immunology
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
FDA classification
FDA Class 2
·Test, Epithelial Ovarian Tumor Associated Antigen (He4)
AXSYM BARBITURATES II U
FDA 510(k)
FDA Class 2
·Clinical Toxicology
WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
DBEST HCG 2 IU/ML TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·OCU-FLEX
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·OCU-FLEX
CLINICAL ELECTRONIC THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
KAISHOU VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pressure Therapy System
FDA 510(k)
FDA Class 2
·Physical Medicine
Pressure Therapy System PT1003
FDA 510(k)
FDA Class 2
·Physical Medicine
Pressure Therapy System PT1003
FDA 510(k)
FDA Class 2
·Physical Medicine
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·OCU-FLEX-53 SOFT CONTACT LENSES
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
FDA 510(k)
FDA Class 2
·Immunology
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
FDA 510(k)
FDA Class 2
·Ophthalmic