ABL SYSTEM 625, 615, 605

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

IllumiFlow Laser Cap

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

FDA 510(k)

FDA Class 2 ·Microbiology

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

Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

Radlink GPS Pro Imaging

FDA 510(k)

FDA Class 2 ·Radiology

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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM