347 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 1
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THORACIC CATHTER STYLET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATHO DX LATEX AGGLUTINATION STREP B KIT
FDA 510(k)
FDA Class 1
·Microbiology
CKMB ISOENZYME CONTROL-LEVEL 1,2.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT
FDA 510(k)
FDA Class 1
·General Hospital
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
FDA 510(k)
FDA Class 1
·Microbiology
KOZY COMFORT INFANT POSITIONER
FDA 510(k)
FDA Class 1
·General Hospital
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
FDA 510(k)
FDA Class 1
·Microbiology
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION
FDA 510(k)
FDA Class 1
·General Hospital
IMMULITE TOTAL TESTOSTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
FDA 510(k)
FDA Class 1
·Microbiology
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE DHEA-S04
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FINE OPTICS
FDA 510(k)
FDA Class 1
·Ophthalmic
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry