1,634 results · 31ms · Sources: EU EUDAMED, US FDA

G1B PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CK-B RIA KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DELFIA DIGOXIN

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CARDIO CK-B RIA KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LAPARETTE, MODEL LAP J L S H N

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)
FDA Class 2 ·Neurology

XTRACTOR, MODEL M143

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

ELITE SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

PERSONAL KINETIGRAPH (PKG) SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

Personal Kinetigraph (PKG) System

FDA 510(k)
FDA Class 2 ·Neurology

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)
FDA Class 2 ·Cardiovascular

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·OMNISCEPT(TM) KB SYSTEM

AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER

FDA 510(k)
FDA Class 2 ·Anesthesiology

RADIOPAQUE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

EMIT IIC CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMIT-ST SERUM CALBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology