ITI ANGLED ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

SCANLAN/TAHERI VALVULOTOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTENSION TUBE PUMP SET

FDA 510(k)

FDA Class 2 ·General Hospital

COBAS-FP REAGENTS FOR VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEISS 40 SL/P PHOTO SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHURCHILL 1.2 MICRON LIQUID FILTER SET

FDA 510(k)

FDA Class 2 ·General Hospital

EDWARDS TRANSFEMORAL BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

FDA 510(k)

FDA Class 2 ·Cardiovascular

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)

FDA 510(k)

FDA Class 2 ·Neurology

Impulse Angiographic Catheter, Expo Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra Coil 400, Ruby Coil System, POD System

FDA 510(k)

FDA Class 2 ·Neurology

Ascendra Balloon Aortic Valvaloplasty Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORVUS Radiation Therapy Planning System

FDA 510(k)

FDA Class 2 ·Radiology

CONFOCAL MICROSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic

FRUCTOSAMINE TEST (ROCHE)

FDA 510(k)

FDA Class 2 ·Hematology