SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN

FDA 510(k)

FDA Class 2 ·Cardiovascular

Checkpoint, Checkpoint Head & Neck

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STIMULATION/DISSECTION INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SANPOINT MENSTRUAL TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IAFP MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT

FDA 510(k)

FDA Class 2 ·Microbiology

IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD

FDA 510(k)

FDA Class 2 ·Microbiology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL RIGID GAS PERMEABLE CONTACT LENS MATERIAL

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·VISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES

Stimulator, Nerve

FDA classification

FDA Class 2 ·Stimulator, Nerve

Reservoir, Blood, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass

Kidney Perfusion Kit

FDA classification

FDA Class 2 ·Kidney Perfusion Kit

Parenteral Administration Kit

FDA classification

FDA Class 2 ·Parenteral Administration Kit

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODULAR PORP AND TORP MODEL TBD

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORTHOLOC™ 2 Lapidus with Rotation System

FDA 510(k)

FDA Class 2 ·Orthopedic