25 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Colorimetry, Acetaminophen
FDA classification
FDA Class 2
·Colorimetry, Acetaminophen
Spectral CT 7500 RT
FDA 510(k)
FDA Class 2
·Radiology
POLARIS 100/200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CORTEK URETHEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DX SERIES FINGER SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Elecsys ANti-HCV II (100/200 tests)
ABBOTT ARCHEITECT TOTAL B-HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT AXSYM TROPONIN-I
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT TOTAL T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUMINEX LX 100/200 INSTRUMENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HCV II (100/200 tests) Immunoassay
IMASK, MODELS 100, 200 AND 300
FDA 510(k)
FDA Class 2
·Anesthesiology
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
FDA 510(k)
FDA Class 2
·Neurology
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
FDA 510(k)
FDA Class 2
·Cardiovascular
MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
FDA 510(k)
FDA Class 2
·Radiology
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
FDA 510(k)
FDA Class 2
·Hematology
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
FDA 510(k)
FDA Class 2
·Cardiovascular