231 results · 37ms · Sources: EU EUDAMED, US FDA

STAT PROFILE M7 ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABL8X7 FLEX

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RENALYZER PRX 90

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Nova StatSensor Creatinine Hospital Meter System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

I-STAT SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Electrode, Ion Based, Enzymatic, Creatinine

FDA classification
FDA Class 2 ·Electrode, Ion Based, Enzymatic, Creatinine

BAUSCH & LOMB CLEANING PAD

FDA 510(k)
FDA Class 2 ·Ophthalmic

MIVI Mi-AXUS Guide Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VersaD Delivery Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTACT LENS WITH COLOR ADDITIVE

FDA 510(k)
FDA Class 2 ·Ophthalmic

AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ISAAC 1.5 T MR SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CAL-FORM DENTAL IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

ZIRBLOCK

FDA 510(k)
FDA Class 2 ·Dental

THE BREATHE EASE NURSERY VAPOR TENT

FDA 510(k)
FDA Class 2 ·Anesthesiology

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval
FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval
FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM