BOSTON SCIENTIFIC V-18 CONTROL WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITREA ENDOVASCULAR STENT PLANNING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRIME CEMENTED CALCAR FEMORAL STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

BRAUN HEMOSTASIS INTRODUCERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

YOUNG D'GRANULATOR

FDA 510(k)

FDA Class 2 ·Dental

PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

SKIPPI POWERED WHEELCHAIR FOR CHILDREN

FDA 510(k)

FDA Class 2 ·Physical Medicine

REPROCESSED SURGICAL ELECTRIC INSTRUMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

R & D BATTERIES, INC. PART # 5003, 5198, 5253

FDA 510(k)

FDA Class 2 ·General Hospital

ZelanteDVT Thrombectomy Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advanced Research Medical Trident SI Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292

FDA 510(k)

FDA Class 2 ·General Hospital

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

FDA 510(k)

FDA Class 2 ·Cardiovascular

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resoundant Acoustic Driver System

FDA 510(k)

FDA Class 2 ·Radiology