525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR

FDA 510(k)

FDA Class 2 ·Radiology

AIROX AXR. 1A

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTRESCREEN BETA-HCG ENZYME IMMUNO

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VENTREZYME DIGOXIN IMMUNOASSAY DIGOX

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VENTREZYME T3 IMMUNOASSAY T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREZYME THEOPHYLLINE IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VENTREXYME EIA CONTROLS IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX PREGNANCY TEST KIT ENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREZYME T4 IMMUNOASSAY T4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTRESCREEN HCG URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

DeepTek CXR Analyzer v1.0

FDA 510(k)

FDA Class 2 ·Radiology

Dental CT Scanner AXR

FDA 510(k)

FDA Class 2 ·Radiology

Lunit INSIGHT CXR Triage

FDA 510(k)

FDA Class 2 ·Radiology

AIMI-Triage CXR PTX

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX(R) - .014 CORONARY DILATATION CATHETER

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

FDA 510(k)

FDA Class 2 ·Ophthalmic