RETIC-CHEX

FDA 510(k)

FDA Class 2 ·Hematology

PARA 5 DIFF

FDA 510(k)

FDA Class 2 ·Hematology

CD-CHEX CD 34

FDA 510(k)

FDA Class 2 ·Hematology

DIGITCARE I.V. START KIT

FDA 510(k)

FDA Class 2 ·General Hospital

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

GATIFLOXACIN, 5 UG, BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

RADIOMETER ACID BASE LABORATORY-ABL-3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

SYNERCID, 15 UG, BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

TELAVANCIN 30 UG, BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

ANTIGENZ CHLAMYDIA

FDA 510(k)

FDA Class 2 ·Neurology

Frontier X Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALIBRATING SOLUTION FOR ABL-1 & 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CALIBRATING SOLUTION FOR ABL-1 & 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Able Medical Devices Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·MOBILE SENOGRAPHE 2000D

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

FDA 510(k)

FDA Class 2 ·Microbiology

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

FDA 510(k)

FDA Class 2 ·Microbiology