395 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Emit® II Plus Buprenorphine Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMBU SUCTION BOOSTER
FDA 510(k)
FDA Class 2
·General Hospital
BOTTLE, CONDENSATE (#1628)
FDA 510(k)
FDA Class 2
·General Hospital
BIRD 1000 PV PORTABLE VENTILATOR
FDA 510(k)
FDA Class 2
·General Hospital
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
cobas BKV
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
FDA 510(k)
FDA Class 2
·Microbiology
PHOENIX 4.0 MM DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PHOENIX 4.0 MM HA COATED DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS
FDA 510(k)
FDA Class 2
·Dental
MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
LungQ v3.0.0
FDA 510(k)
FDA Class 2
·Radiology
LungQ Software
FDA 510(k)
FDA Class 2
·Radiology
MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
Transpara (2.1.0)
FDA 510(k)
FDA Class 2
·Radiology
METRICATH SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FASTX STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
FDA 510(k)
FDA Class 2
·Dental