WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

InMode System with vTone Applicator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARTO SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTENSIF

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Chameleon PTA Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Interlude and private label Unscented 3-piece compact applicator tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDO PAT 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONFIDENCE HIGH VISCOSITY BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

BIRTHTRACK (A.K.A. CLM)

FDA 510(k)

FDA Class 2 ·Ophthalmic

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COR ANALYZER 1, VERSION 1.4

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DreaMed Advisor Pro

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

V30 system, V20 system, V10 system, V-VR Hand piece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Auryon Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViaOne Epicardial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKIN CARE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infinix Universal Composite

FDA 510(k)

FDA Class 2 ·Dental