TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY

FDA 510(k)

FDA Class 2 ·Radiology

PS MEDICAL IPI ACCESS KIT

FDA 510(k)

FDA Class 2 ·General Hospital

APTT-ES REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

EDWARDS TRANSFEMORAL BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SB ANCHOR

FDA 510(k)

FDA Class 2 ·Dental

Snap Insulin Pump System

FDA 510(k)

FDA Class 2 ·General Hospital

Pavati Z40.2 Zirconia

FDA 510(k)

FDA Class 2 ·Dental

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartSpan Steerable Sheath Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARK Tramadol Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNILINK. 018 BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017

FDA 510(k)

FDA Class 2 ·Microbiology

TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS

FDA 510(k)

FDA Class 2 ·General Hospital

ESENSOR WARFARIN SENSITIVITY SALIVA TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMEDITECH IMMUTEST MILTI-DRUG SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MEDICAL AIR COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE

FDA 510(k)

FDA Class 2 ·Anesthesiology