Apollo ESG NXT System, Apollo REVISE NXT System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

FDA classification

FDA Class 2 ·Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100

FDA 510(k)

FDA Class 2 ·Cardiovascular

Polyfusion IV Administration Sets

FDA 510(k)

FDA Class 2 ·General Hospital

Aptiva CTD Essential Reagent

FDA 510(k)

FDA Class 2 ·Immunology

Lorals

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GLYDE DAM LOLLYES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Harmony Latex Dam, Harmony Non-Latex Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRUST DAM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SHEER GLYDE DAMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SancDam Latex Oral Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MOBINEURO Alita Intraoperative MRI System

FDA 510(k)

FDA Class 2 ·Radiology

OmniTom Elite

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD ATD-T INTERFACE DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

CTD MARK I TRACTION DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

BENTLEY THEROMODILUTION CATHETER #BTD-7F

FDA 510(k)

FDA Class 2 ·Cardiovascular

EROS-CLITORAL THERAPY DEVICE (CTD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SUPERJET BTD BLEEDING TIME DEVICE DISP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VARELISA RECOMBI CTD SCREEN, MODEL 13096

FDA 510(k)

FDA Class 2 ·Immunology