CD HORIZON Spinal System, IPC POWEREASE System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDTRONIC XOMED, INC.

FDA 510(k)

FDA Class 2 ·Dental

MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY FUSION RECIRCULATION LINE MODEL RCL841

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

TurboHawk Plus Directional Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AQUAMANTRYS3 BSC 9.1S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kyphon HV-R Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

FDA 510(k)

FDA Class 2 ·Hematology

CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Chocolate PTA Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CareLink SmartSync Device Manager - Pacing System Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery