543 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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EXL ANEM CAL, MODEL RC640
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
FDA 510(k)
FDA Class 2
·Immunology
MODEL 9210 DELIVERY CATHETER, MODEL 9210
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION CHEMISTRY III CALIBRATORY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
FDA 510(k)
FDA Class 2
·Cardiovascular
LINQ II Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
FDA 510(k)
FDA Class 2
·Microbiology
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
FDA 510(k)
FDA Class 2
·Cardiovascular
Rickettsia Real-time PCR Assay
FDA 510(k)
FDA Class 2
·Microbiology
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
FDA 510(k)
FDA Class 2
·Clinical Chemistry