513 results · 23ms · Sources: EU EUDAMED, US FDA

Sysmex Automated Blood Coagulation Analyzer CS-2100i

FDA 510(k)
FDA Class 2 ·Hematology

MOSS VRS Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

N Latex FLC kappa, N Latex FLC lambda

FDA 510(k)
FDA Class 2 ·Immunology

MRI Patient Monitor TeslaDUO

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sysmex CS-2100i

FDA 510(k)
FDA Class 2 ·Hematology

MOSS 100 Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

INNOVANCE VWF Ac

FDA 510(k)
FDA Class 2 ·Hematology

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

FDA 510(k)
FDA Class 2 ·Hematology

vWF Ag

FDA 510(k)
FDA Class 2 ·Hematology

Neuromuscular Transmission Monitor TOF3D

FDA 510(k)
FDA Class 2 ·Anesthesiology

N Latex FLC kappa assay, N Latex FLC lambda assay

FDA 510(k)
FDA Class 2 ·Immunology

AFFINITY MEDICAL PATIENT CABLE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

FDA 510(k)
FDA Class 2 ·Immunology

N Latex Cystatin C; N Protein Standard UY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N Latex FLC kappa, N Latex FLC lambda

FDA 510(k)
FDA Class 2 ·Immunology

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)
FDA Class 2 ·Hematology

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)
FDA Class 2 ·Hematology

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

FDA 510(k)
FDA Class 2 ·Immunology

NR Recorder

FDA 510(k)
FDA Class 2 ·Cardiovascular

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

FDA 510(k)
FDA Class 2 ·Hematology