DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

FDA 510(k)

FDA Class 2 ·Radiology

Edwards Pressure Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

Swan-Ganz Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOCARDIAL PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra System (Reperfusion Catheter RED 43)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ZEISS ENDOLIVE STERO ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHUNTCHECK - CSF SHUNT FLOW DETECTOR

FDA 510(k)

FDA Class 2 ·Neurology

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity

FDA 510(k)

FDA Class 2 ·Anesthesiology

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHURCHILL-H VENTED IV SET

FDA 510(k)

FDA Class 2 ·General Hospital

VACUTAINER PLUS TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUGE GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3DSEE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHARPLAN MODEL 1080S CO2 SURGICAL LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABUSCREEN(R) ONTRAK(TM) FOR THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500

FDA 510(k)

FDA Class 2 ·Hematology

SCISSORS,GRASPERS,FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100

FDA 510(k)

FDA Class 2 ·Cardiovascular