290 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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I.V. BAG ADDISEAL
FDA 510(k)
FDA Class 2
·General Hospital
VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
FDA 510(k)
FDA Class 2
·General Hospital
BAXA ADDISEAL
FDA 510(k)
FDA Class 2
·General Hospital
VENTED I.V. TRANSFER NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE ONLINE TDM PHENYTOIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Omega VL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIRIO H3
FDA 510(k)
FDA Class 2
·Radiology
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
FDA 510(k)
FDA Class 2
·Immunology
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
FDA 510(k)
FDA Class 2
·Immunology
AXIS-SHIELD ACVTIVE-B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
FDA 510(k)
FDA Class 2
·Immunology