2,000 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
FDA 510(k)
FDA Class 2
·Hematology
Dimension Vista MMB Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
FDA 510(k)
FDA Class 2
·Radiology
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
FDA 510(k)
FDA Class 2
·Immunology
Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INNOVANCE D-DIMER, MODEL OPBP09
FDA 510(k)
FDA Class 2
·Hematology
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISA ENZ 2 CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EXL ANEM CAL, MODEL RC640
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Amylase_2 (AMY_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry