7,347 results · 45ms · Sources: EU EUDAMED, US FDA

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS

FDA 510(k)
FDA Class 2 ·Hematology

DBEST ONE-STEP HCG SERUM/URINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS

FDA 510(k)
FDA Class 2 ·Radiology

R&D CBC-3D + CRP HEMATOLOGY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)

FDA 510(k)
FDA Class 2 ·General Hospital

CBC-CAL PLUS HEMATOLOGY CALIBRATOR

FDA 510(k)
FDA Class 2 ·Hematology

A16 BLOOD FLOW MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLATELET-TROL II

FDA 510(k)
FDA Class 2 ·Hematology

DBEST METHAMPHETAMINES TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MEDTRONIC CATHETER ACCESS PORT MODEL 8500

FDA 510(k)
FDA Class 2 ·General Hospital

MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION

FDA 510(k)
FDA Class 2 ·Neurology

PEDIATRIC VITRECTOMY LENS SET

FDA 510(k)
FDA Class 2 ·Ophthalmic

MODEL 3487A PISCES EPIDURAL LEAD

FDA 510(k)
FDA Class 2 ·Neurology

SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL

FDA 510(k)
FDA Class 2 ·Radiology

SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE

FDA 510(k)
FDA Class 2 ·Neurology

CBC-4K HEMATOLOGY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

AMENDMENT LIFEPAK 100, NPN 045

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716

FDA 510(k)
FDA Class 2 ·Anesthesiology