Bioptimal Bipolar Pacing Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Biofourmis Everion+ (G2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ProSeal™ In Line Pump Set (423850)

FDA 510(k)

FDA Class 2 ·General Hospital

SMARTez elastomeric infusion pump

FDA 510(k)

FDA Class 2 ·General Hospital

HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Claritas iPET

FDA 510(k)

FDA Class 2 ·Radiology

BPROSOFT CASP PC SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

F88 URE-SD/RD Flexible Ureteroscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLANCET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SERV MEDICAL CDSS

FDA 510(k)

FDA Class 2 ·Radiology

SuperSlyde Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Twoplus Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Hushd Pro Avera

FDA 510(k)

FDA Class 2 ·Dental

ANT-X System

FDA 510(k)

FDA Class 2 ·Radiology

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

FDA 510(k)

FDA Class 2 ·Radiology

VENNER TRACHEAL SEAL MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology