Reveal LINQ

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRAILRUNNER GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOCATH ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIDERX EMBOLIC PROTECTION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GV 11 (TM), MODEL 9700

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Luja Coude (20108 Male CH18 - large packaging)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Conventus Orthopaedics Ulna Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBOLD Fibered Detachable Coil System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medtronic Temporary External Pacemaker 53401

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M Comply Hydrogen Peroxide Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

LUMAX CYSTOMETRY ADMINISTRATION TUBE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMS COAGULOOP RESECTION ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XE CHECK

FDA 510(k)

FDA Class 2 ·Hematology

NIROYAL BILIARY PREMOUNTED STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology