ToothWave™

FDA 510(k)

FDA Class 2 ·Dental

Tyto Insights for Crackles Detection

FDA 510(k)

FDA Class 2 ·Anesthesiology

PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NerivioInfinity

FDA 510(k)

FDA Class 2 ·Neurology

SPINEASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

LYMPHA PRESS 201MAX, MODEL 201MAX

FDA 510(k)

FDA Class 2 ·Cardiovascular

CG-6108 ARRHYTHMIA ECG EVENT RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BriefCase

FDA 510(k)

FDA Class 2 ·Radiology

AQUARIUS Gastrostomy Replacement Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIAC SCANNER AND PROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Pollogen Legend System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tixel i (TXLI0001)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOMOVE 3000

FDA 510(k)

FDA Class 2 ·Physical Medicine

Tigertriever and Tigertriever 17 Revascularization Devce

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFEBRIS STERILE CIRCUMCISION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CureSight-CS100

FDA 510(k)

FDA Class 2 ·Ophthalmic

Discovery NM 750b Bopsy

FDA 510(k)

FDA Class 1 ·Radiology

IC-PRO SYSTEM, VERSION 3.1.0.4

FDA 510(k)

FDA Class 2 ·Radiology

MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA

FDA 510(k)

FDA Class 2 ·Radiology