System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MS 2 MICROBIAL SYSTEM

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

FDA 510(k)

FDA Class 2 ·Radiology

BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

FDA 510(k)

FDA Class 2 ·Radiology

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

FDA 510(k)

FDA Class 2 ·Radiology

COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CFR QUANT

FDA 510(k)

FDA Class 2 ·Radiology

HeartSee

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL

SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA HSV 1&2 DIRECT

FDA 510(k)

FDA Class 2 ·Microbiology

ACCELERATOR APS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

Theranos Herpes Simplex Virus-1 IgG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

FDA 510(k)

FDA Class 2 ·Microbiology

CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

FDA 510(k)

FDA Class 2 ·Microbiology