191 results · 26ms · Sources: EU EUDAMED, US FDA

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