P-Cure Proton Therapy System (PPTS)

FDA 510(k)

FDA Class 2 ·Radiology

AQUARIUS NASAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BELTBEAT WF-400

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BEAMAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Auryon Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PathKeeper System

FDA 510(k)

FDA Class 2 ·Neurology

POLARIS WR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CG-3250 MINIRECEIVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BriefCase, RIB Fractures Triage (RibFx)

FDA 510(k)

FDA Class 2 ·Radiology

8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACTIVECARE DVT ACTIVECARE+SFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOSCOUT

FDA 510(k)

FDA Class 2 ·Radiology

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS

FDA 510(k)

FDA Class 2 ·General Hospital

Tixel System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BRIVO NM 615

FDA 510(k)

FDA Class 2 ·Radiology

HX Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital