SEA MED DDD PACING SYSTEM ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 5401B TEST CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONITOR, PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PK-141 PATIENT CABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CPI MODEL 2215/SEAMED MODEL 3400

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACER SENSING ANALYZER (PSA 100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRODE/PACER SYSTEM ANALYZER PMA 400

FDA 510(k)

FDA Class 2 ·Cardiovascular

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

NG-Test CARBA 5

FDA 510(k)

FDA Class 2 ·Microbiology