Sera

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Orion

FDA 510(k)

FDA Unclassified ·Unknown

VisualEyes

FDA 510(k)

FDA Class 2 ·Neurology

Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE JUVIA, MODEL 9EJU7465

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cranial PSI

FDA 510(k)

FDA Class 2 ·Neurology

ELLIPSE LIGHT SPT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APrioCore Plus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CADScor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Morrison Steerable Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VisualEyes

FDA 510(k)

FDA Class 2 ·Neurology

TeesuVac Breast Biopsy Device Mark 1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

FDA 510(k)

FDA Class 2 ·Neurology

ODI-Tech

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA CRT-P/CONSULTA CRT-P