Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEADS

FDA Pre-Market Approval

IMPLANTABLE PACEMAKER LEAD

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEAD

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096

FDA 510(k)

FDA Class 2 ·Cardiovascular

5F GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LV-1 HEMOSTASIS VALVE, MODEL #6789

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASC BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular