1,283 results
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32ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 2
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AIA-PACK CTNI 2ND-GEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STARLIGHT, MODEL PD9012
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ST AIA-PACK PA
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX(R) HAVAB(R)-M
ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ABBOTT HAVAB -M EIA
Models 2200DR and 1600DR Digital Stationary Radiographic Systems
FDA 510(k)
FDA Class 2
·Radiology
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK PROG III Calibrator Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
FDA 510(k)
FDA Class 2
·Cardiovascular
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK DHEA-S CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK CYSTATIN C, MODEL 025217
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ST AIA-PACK PROG II Calibrator Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ULTIMA SMARTBELT, MODEL 0560
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDIBYTE, MODEL MP8
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDIPALM-20
FDA 510(k)
FDA Class 2
·Neurology
ULTIMA SNORING MIKE, MODEL 0540
FDA 510(k)
FDA Class 2
·Anesthesiology