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

MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS

FDA 510(k)

FDA Class 2 ·Radiology

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CANON 60 DEGREE FUNDUS CAMERA CF-60S

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCIMED TRIGUIDE GUIDE CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Invacare Platinum Mobile Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDB II VIBRATING DRAINAGE BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Dental

DEPILASE TWIN LASE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery