VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3 FOR NORFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

FORA GTel Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS

FDA 510(k)

FDA Class 2 ·Radiology

KIMBERLY-CLARK CHILD'S FACEMASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URINARY DRAINAGE CONTAINER 2013 WITH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA

FDA 510(k)

FDA Class 2 ·Microbiology

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DRI PRIMIDONE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

USCI MAINSTAY GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSTEM U3 FOR GENTAMICIN

FDA 510(k)

FDA Class 2 ·Microbiology

SYSTEM U3 FOR NITROFURANTOIN

FDA 510(k)

FDA Class 2 ·Microbiology

THE E TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology