Dental Barrier and Sleeves

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ameda GLO Wearable Breast Pump (Model W8S)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Skypro, SP01 Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fractional CO2 Laser Therapy System (EXFU CO2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bodygard SFS Surgical Gown Level 4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Q Switched Nd: YAG Laser machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle

FDA 510(k)

FDA Class 2 ·General Hospital

Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

FDA 510(k)

FDA Class 2 ·Radiology

Procedure mask/Surgical mask/Face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)

FDA 510(k)

FDA Class 2 ·Radiology

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

FDA 510(k)

FDA Class 2 ·Neurology

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AGE Automatic Upper Arm Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

FDA 510(k)

FDA Class 2 ·Neurology

FloNavi Open Field Fluorescence Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Single-use Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dental Cone-beam Computed Tomography

FDA 510(k)

FDA Class 2 ·Radiology