ELITECROSS Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO GUIDE CATHETER XP

FDA 510(k)

FDA Class 2 ·Cardiovascular

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15

FDA 510(k)

FDA Class 2 ·Cardiovascular

PIONEER PLUS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RVT CTO DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RA-308 Excimer Laser System, Excimer Laser Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO THE CROSSER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROSSER CTO Recanalization Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCELOT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PowerWire Radiofrequency Guidewire Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

ATM Glove

FDA 510(k)

FDA Class 1 ·General Hospital

NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)

FDA UDI

NUSMILE, LTD.·00810118103995·NuSmile NeoLINER LC Sample Pack (1 g Syringe + ...

Axios™

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506008086·Stent and Electrocautery - Enhanced Delivery Sy...

Axios™

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506008093·Stent and Electrocautery - Enhanced Delivery Sy...

Axios™

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729951179·Stent and Electrocautery - Enhanced Delivery Sy...