uCT 530, uCT 550

FDA 510(k)

FDA Class 2 ·Radiology

Arm Electronic Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

V-Patch Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

FDA 510(k)

FDA Class 2 ·Radiology

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Microwave Therapeutic System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Plus Medical Chemotherapy Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Laser Hair Growth Comb

FDA 510(k)

FDA Class 2 ·Physical Medicine

WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

FDA 510(k)

FDA Class 2 ·Cardiovascular

Med-link Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Powered Wheelchair (NXN20-208, NXN20-211)

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRANSTEK BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACHILLES

FDA 510(k)

FDA Class 2 ·Radiology

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental