STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BUTTON REPLACEMENT GASTROSTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Omnipod 5 SmartBolus Calculator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MENTOR ADVENT A/B SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IMDX VANR FOR ABBOTT M2000

FDA 510(k)

FDA Class 2 ·Microbiology

ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

XenoSure Dura Biologic Patch

FDA 510(k)

FDA Class 2 ·Neurology

APEX K2 HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IMAGECHECKER CT CAD SOFTWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

APEX ARC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CONCERTO BIPOLAR NEEDLE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELCAM STOPCOCKS AND MANIFOLDS

FDA 510(k)

FDA Class 2 ·General Hospital

SYNTHES CERVICAL VERTABRAE PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS

FDA 510(k)

FDA Class 2 ·General Hospital

SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MITEK ABSORBABLE TOGGLE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SONOS 2000, SONOS 2500 (M2406 A)

FDA 510(k)

FDA Class 2 ·Radiology

ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q-STATION

FDA 510(k)

FDA Class 2 ·Radiology