REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Laser Cap, Model: Hat-01

FDA 510(k)

FDA Class 2 ·Physical Medicine

ANGIOGRAPHY SYRINGE KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 4310 PSARRAY2 EEG ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

FDA 510(k)

FDA Class 2 ·Neurology

VIRTUOST

FDA 510(k)

FDA Class 2 ·Radiology

PSA4000 EEG MONITOR WITH FRONTAL PSI

FDA 510(k)

FDA Class 2 ·Neurology

EQUINOX DIGITAL EEG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor

FDA 510(k)

FDA Class 2 ·Radiology

MULTITAK SS SUTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

NAV PAK Needle, NIM NAV PAK Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 1220, OR E-NET (54-62 CM)

FDA 510(k)

FDA Class 2 ·Neurology

MODEL 4300 PSARRAY EEG ELECTRODE SET

FDA 510(k)

FDA Class 2 ·Neurology

MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

FDA 510(k)

FDA Class 2 ·Neurology

PARIETEX POLYESTER MESH WITH INTRODUCER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery