TEMPUSIC PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Suprasorb A + Ag “R”

FDA 510(k)

FDA Unclassified ·Unknown

AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING

FDA 510(k)

FDA Unclassified ·Unknown

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

FDA 510(k)

FDA Class 2 ·General Hospital

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HORIZON Therapy System

FDA 510(k)

FDA Class 2 ·Neurology

CariCloud

FDA 510(k)

FDA Class 2 ·Radiology

ThermoShield HME Filter

FDA 510(k)

FDA Class 2 ·Anesthesiology

M4 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin Pure Mini

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AGILITY

FDA 510(k)

FDA Class 2 ·Radiology

GAMMA-B 25-HYDROXY VITAMIN D RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX METHAMPHETAMINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FACT PLUS ONE-STEP PREGNANCY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MGA 2000 GAS ANALYSER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

LiverMultiScan v5 (LMSv5)

FDA 510(k)

FDA Class 2 ·Radiology

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

FDA 510(k)

FDA Class 2 ·Cardiovascular