THE BREATHE EZ ANTI-SNORING DEVICE

FDA 510(k)

FDA Class 2 ·Dental

ENHANCED COMPENSATING FILTER

FDA 510(k)

FDA Class 2 ·Radiology

PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS

FDA 510(k)

FDA Class 2 ·General Hospital

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MULTICHEM TOTAL PROTEIN REAGENT #S0928

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BILE ACIDS REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OZARK 40

FDA 510(k)

FDA Class 2 ·Dental

STORZ MICROSURGICAL BIPOLAR COAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FACTOR IX DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VDRIVE WITH V-SONO

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

FDA 510(k)

FDA Class 2 ·Microbiology

INSUL-LINE

FDA 510(k)

FDA Class 2 ·General Hospital

L.A.P. II SPRIOMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Navigation Module of the Momentum System

FDA 510(k)

FDA Class 2 ·Neurology