Aptiva Celiac Disease IgA Reagent

FDA 510(k)

FDA Class 2 ·Immunology

ARTHROSCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

Butterfly iQ Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES

FDA 510(k)

FDA Class 2 ·Orthopedic

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

DENALI 501CEMENT

FDA 510(k)

FDA Class 2 ·Dental

QUANTA LITE H-TTG SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

EIDOS 5003 HOLTER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBU CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

LuxCreo Clear Aligner System

FDA 510(k)

FDA Class 2 ·Dental

CUSTOM-HIP TOOL

FDA 510(k)

FDA Class 2 ·Orthopedic

HUBERLOC

FDA 510(k)

FDA Class 2 ·General Hospital

CORMATRIX PROTECT ECM ENVELOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

OPPORTUNITY INC. GENERAL PURPOSE TRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUANTA FLASH H-TTG IGA

FDA 510(k)

FDA Class 2 ·Immunology

BODY FORCE, MODEL BT 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular

URETHRAL CATHETERIZATION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMBISCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CORMATRIX ECM FOR VASCULAR REPAIR

FDA 510(k)

FDA Class 2 ·Cardiovascular