Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System

SOMNOscreen plus PSG+ BT AASM Set

FDA UDI

SOMNOmedics GmbH·04250413401987·

CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Flexible 19G EBUS Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

K-WIRES AND STEINMANN PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

HCT Empty EVA Container Pack

FDA 510(k)

FDA Class 2 ·General Hospital

SAW BLADE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BIOMARC FIDUCIAL MARKER

FDA 510(k)

FDA Class 2 ·Radiology

CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY

FDA 510(k)

FDA Class 2 ·Radiology

CT OIA

FDA 510(k)

FDA Class 1 ·Microbiology

Endoscopic Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

RSV OIA

FDA 510(k)

FDA Class 1 ·Microbiology

SPARROW MOTORIZED SCOOTER

FDA 510(k)

FDA Class 2 ·Physical Medicine

SterilContainer S

FDA 510(k)

FDA Class 2 ·General Hospital

MADAVAC 190

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOMARC GOLD FIDUCIAL MARKER

FDA 510(k)

FDA Class 2 ·Radiology

OSSIFUSE BONE SUBSTITUTE MATERIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGIOMAT 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular