184 results · 19ms · Sources: EU EUDAMED, US FDA

DELFIA(TM) CORTISOL KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ENGSTROM ELIZA CO2 ANALYZER

FDA 510(k)
FDA Class 2 ·Anesthesiology

DELFIA HTSH KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMV SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

ENGSTROM ERICA

FDA 510(k)
FDA Class 2 ·Anesthesiology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

swiftPro™ System

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

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

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

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

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

EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EMIT-TOX SERUM CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VES-TEC/VES-MATIC

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EMIT D.A.U. LOW & MED. CALIBRATORS B

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry