236 results · 39ms · Sources: EU EUDAMED, US FDA
Filters Fda510k ×

CDM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CDM Insights

FDA 510(k)
FDA Class 2 ·Radiology

BOMED-CDM

FDA 510(k)
FDA Class 2 ·Cardiovascular

KING OF HEARTS CDM

FDA 510(k)
FDA Class 2 ·Cardiovascular

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

FDA 510(k)
FDA Class 2 ·Hematology

DIA STRIPS SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

URITEST 10 URINALYSIS REAGENT STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FITKIT I CHECKUP KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACON URINALYSIS REAGENT STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

FITKIT I CHECKUP KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

REAGENT STRIPS FOR URINALYSIS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAKO(TM) PRETEST 5A

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

FDA 510(k)
FDA Class 2 ·Hematology

ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

EZ-COMP

FDA 510(k)
FDA Class 2 ·Dental

CorInsights MRI

FDA 510(k)
FDA Class 2 ·Radiology

PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

FDA 510(k)
FDA Class 2 ·Ophthalmic