InnoCare Specialty Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Myocardial Strain Software Application

FDA 510(k)

FDA Class 2 ·Radiology

3M STERI-VAC STERILIZER/AERATOR

FDA 510(k)

FDA Class 2 ·General Hospital

StrokeSENS LVO

FDA 510(k)

FDA Class 2 ·Radiology

ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Distal Elbow Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

TruPlan Computed Tomography (CT) Imaging Software

FDA 510(k)

FDA Class 2 ·Radiology

cvi42 Auto Imaging Software Application

FDA 510(k)

FDA Class 2 ·Radiology

SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS

FDA 510(k)

FDA Class 2 ·Orthopedic

SnapshotGLO (KB100)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LS-260G MONITOR/RECORDER & DEFIBILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5

FDA 510(k)

FDA Class 2 ·Orthopedic

FIXATION WIRE

FDA 510(k)

FDA Class 2 ·Orthopedic

GEMINUS FOSSA SPECIFIC PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Stablyx CMC Arthroplasty Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

LaborView™ LV1000 Wireless Electrode System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SAM IO Intraosseous Access System

FDA 510(k)

FDA Class 2 ·General Hospital

DISTAL ELBOW PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIGHTWRITER

FDA 510(k)

FDA Class 2 ·Physical Medicine

HEMOGLOBIN ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology