AXSYM ULTRASENSITIVE HTSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BOOTY ENDOSCOPE WARMER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MLT-1000 IR LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

IMX(R) STAT CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

IMX ULTRASENSISTIVE HTSH II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME

FDA 510(k)

FDA Class 2 ·Radiology

OEC 9900 ELITE

FDA 510(k)

FDA Class 2 ·Radiology

OEC 9900 ELITE

FDA 510(k)

FDA Class 2 ·Radiology

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

Vectorcardiograph

FDA classification

FDA Class 2 ·Vectorcardiograph

Catheter, Upper Urinary Tract

FDA classification

FDA Class 2 ·Catheter, Upper Urinary Tract

Internal Hinged Elbow Fixator

FDA classification

FDA Class 2 ·Internal Hinged Elbow Fixator

Wearable Fall Injury Prevention Device

FDA classification

FDA Class 2 ·Wearable Fall Injury Prevention Device

Over-The-Counter Powered Light Based Laser For Acne

FDA classification

FDA Class 2 ·Over-The-Counter Powered Light Based Laser For Acne

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Magnetic Compression Anastomosis System

FDA classification

FDA Class 2 ·Magnetic Compression Anastomosis System