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

I-STAT CREATINE KINASE MB (CK-MB)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIOCENTREX CARDIAC PANEL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUANTECH CK-MB ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Biosensor, Immunoassay, Cpk Or Isoenzymes

FDA classification
FDA Class 2 ·Biosensor, Immunoassay, Cpk Or Isoenzymes

ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

EndoSign® Cell collection device (ES-CYT-102)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSURE WIRE SENSOR, MODEL 12003/12303

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSURE WIRE SENSOR, MODELS 12004/12304

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSUREWIRE SENSOR, MODEL #12001

FDA 510(k)
FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSUREWIRE CERTUS, MODELS 12006 AND 12306

FDA 510(k)
FDA Class 2 ·Cardiovascular

FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

FEMOSTOP, FEMOSTOP PUMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

TIGR Matrix Surgical Mesh

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RADIANALYZER XPRESS

FDA 510(k)
FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710

FDA 510(k)
FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

FDA 510(k)
FDA Class 2 ·Cardiovascular