25 results · 20ms · Sources: EU EUDAMED, US FDA

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