PADNET 2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEM FLOW COUPLER DEVICE AND SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOPOLAR COAGULATING POLYPECTOMY SNARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BILIARY STONE DISLODGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)

FDA 510(k)

FDA Class 2 ·General Hospital

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

FDA 510(k)

FDA Class 2 ·General Hospital

AVI MODEL 600 SYRINGE PUMP, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

Achieve ST Mapping Catheter, Catheter Connecting Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN

FDA 510(k)

FDA Class 2 ·Neurology

VANTAGE VIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

URGENT PC STIMULATOR; URGENT PC LEAD SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIOPULMONARY CANNULA TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPICIDE OPA-28

FDA 510(k)

FDA Class 2 ·General Hospital

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2

FDA 510(k)

FDA Class 2 ·Cardiovascular