191 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ExSpiron 2Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
EXSPIRON 1XI
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
Repagyn vaginal suppositories
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIRIO H3
FDA 510(k)
FDA Class 2
·Radiology
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
FDA 510(k)
FDA Class 2
·General Hospital
STERI-DENT, STERI-SURE
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DENTRONIX MODEL 2000
FDA 510(k)
FDA Class 2
·General Hospital
COX RAPID HEAT TRANSFER STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
U. V. GERMICIDAL UNIT
FDA 510(k)
FDA Class 2
·General Hospital
DRY HEAT STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
INOX DRY HEAT STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital