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

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

ULTRACARE

FDA 510(k)

FDA Class 2 ·General Hospital

Surgical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADMS BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RESTORATION ADM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERISMA-LP

FDA 510(k)

FDA Class 2 ·Orthopedic

SMD ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

REST EAZY Appliance

FDA 510(k)

FDA Class 2 ·Dental

Clear Image Aligners

FDA 510(k)

FDA Class 2 ·Dental

ACRYLIC HERBST SPLINT APPLIANCE

FDA 510(k)

FDA Class 2 ·Dental