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

DUET GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GO GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LXN BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LXN FRUCTOSAMINE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DUET II GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

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

ANT. & POST. RESTORATIVE POWDER LIQ.

FDA 510(k)
FDA Class 2 ·Dental

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY

FDA 510(k)
FDA Class 2 ·Hematology

PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR

FDA 510(k)
FDA Class 2 ·General Hospital

PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE

FDA 510(k)
FDA Class 2 ·Anesthesiology

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4

FDA 510(k)
FDA Class 2 ·Physical Medicine

INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

FDA 510(k)
FDA Class 2 ·Physical Medicine

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)
FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLEXIPORT ECOCUFF

FDA 510(k)
FDA Class 2 ·Cardiovascular