ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

Orion

FDA 510(k)

FDA Unclassified ·Unknown

BioXmark

FDA 510(k)

FDA Class 2 ·Radiology

3Shape Splint Design

FDA 510(k)

FDA Class 2 ·Dental

COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65

FDA 510(k)

FDA Class 2 ·Neurology

bk2300

FDA 510(k)

FDA Class 2 ·Radiology

VisualEyes

FDA 510(k)

FDA Class 2 ·Neurology

Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MagVita TMS Therapy System

FDA 510(k)

FDA Class 2 ·Neurology

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202

FDA 510(k)

FDA Class 2 ·Radiology

EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KIDScore D3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ITC HEARING AID CLUB MODEL LM50

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

CLICK-ON

FDA 510(k)

FDA Class 2 ·General Hospital

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology