STERILIZATION CASES AND TRAYS

FDA 510(k)

FDA Class 2 ·General Hospital

AOS PROXIMAL HUMERAL PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

TIPI

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

IGAR System (1001.A)

FDA 510(k)

FDA Class 2 ·Radiology

MAXPOWER RELIEF

FDA 510(k)

FDA Class 2 ·Neurology

DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER

FDA 510(k)

FDA Class 2 ·Orthopedic

REPLACE TPS COATED IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE

FDA 510(k)

FDA Class 2 ·Dental

Oral Device OA, Oral Device S

FDA 510(k)

FDA Class 2 ·Dental

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHODONTIC BITE

FDA 510(k)

FDA Class 2 ·Dental

ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

FDA 510(k)

FDA Class 2 ·Anesthesiology

SHIKANI SPEAKING VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

OCTAVE SPEEDER SPINE

FDA 510(k)

FDA Class 2 ·Radiology

PUREFILL OXYGEN COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

REPLACE TITANIUM IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery