CARIOLINE(ELECTROCARDIOGRAPH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF

FDA 510(k)

FDA Class 2 ·Cardiovascular

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

FDA 510(k)

FDA Class 2 ·General Hospital

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs HV, BonOs MV, BonOs LV

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs Inject, Pedicle screw kits, Cement pusher

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

FDA 510(k)

FDA Class 2 ·Orthopedic

ReVene Thrombectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOPA12 Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

LIPIDURE REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

NFLK-2501 Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED

FDA 510(k)

FDA Class 2 ·Anesthesiology

COMFORT - CUF

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSA-CUF

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONE-CUF

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS

FDA 510(k)

FDA Class 2 ·Radiology

360CAS

FDA 510(k)

FDA Class 2 ·Neurology

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE

FDA 510(k)

FDA Class 2 ·Anesthesiology