RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCUTRAK PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENCOR ENSPIRE BREAST BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VACCESS PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRUE BA V BALLOON VALVULOPLASTY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dorado™ PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GlidePath 13F Long-Term Hemodialysis Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery