EUROIMMUN Anti-BP230-CF ELISA (IgG)

FDA 510(k)

FDA Class 2 ·Immunology

Ultramatrix EUS Balloon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoSound Vision System; EVS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MESACUP MODELS BP180 AND BP230 ELISA KITS

FDA 510(k)

FDA Class 2 ·Immunology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN

MEDELA INVIA WOUND THERAPY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOVIT AT-102 G2

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASOUND COUPLING GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MLS ELECTROMYOGRAPHIC PREAMPLIFIER

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEDELA THOPAZ

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Freestyle Flex

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology