PregSense

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EndoGI S-Path Biliary Stent System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Annabella Double Breast Pump (ADO-US23-1000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUANTIX/ND DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RF TENT

FDA 510(k)

FDA Class 2 ·Radiology

Temple Touch Pro (TTP) Non-invasive temperature monitoring system

FDA 510(k)

FDA Class 2 ·General Hospital

ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIOLA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Legend X Applicator VO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cortex CAD/CAM Abutments

FDA 510(k)

FDA Class 2 ·Dental

InMode Evolve System with the Tone Applicator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Drakon and Sequre Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sapphire Infusion Pump

FDA 510(k)

FDA Class 2 ·General Hospital

WALKCARE P200 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tyto Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

POLESTAR N-10

FDA 510(k)

FDA Class 2 ·Radiology

WIZAIR COMPRESSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BODYGAURD PAIN MANAGER INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Vented Vial Adapter 20mm

FDA 510(k)

FDA Class 2 ·General Hospital

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

FDA 510(k)

FDA Class 2 ·Orthopedic