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

NYLON NONABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILK NONABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

SURGIVISION INC. CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ClearPoint System

FDA 510(k)

FDA Class 2 ·Neurology

ClearPoint System

FDA 510(k)

FDA Class 2 ·Neurology