Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EPX-4440HD DIGITAL VIDEO PROCESSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Control-IQ+ technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE PICC WAND PEELABLE SAFETY INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART SPOT

FDA 510(k)

FDA Class 2 ·Radiology

Tandem Mobi insulin pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fujifilm Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Philips BlueControl

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)

FDA 510(k)

FDA Class 2 ·Anesthesiology

EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PANORET, MODEL 1000A

FDA 510(k)

FDA Class 2 ·Ophthalmic

Fujifilm Video Colonoscope Model EC-600WL V2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FUJIFILM Endoscope Models EC-600HL and EC-600LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SILKPRO laser hair removal system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery