ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Electrosurgical accessory

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800

FDA 510(k)

FDA Class 2 ·Physical Medicine

Advocate Non-Contact Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

WiZARD 510 Nasal Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Temp Pal

FDA 510(k)

FDA Class 2 ·General Hospital

“MoFi” Cell Culture Basal Medium

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIGITAL TEMPERATURE MONITOR; MODEL KY-01

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRACONGRUENT INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

FDA 510(k)

FDA Class 2 ·Radiology

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTAI Surgical Mask (non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BB Base 3D printing resin for denture base

FDA 510(k)

FDA Class 2 ·Dental

Ezvena IPC, Ezvena SQS

FDA 510(k)

FDA Class 2 ·Cardiovascular

AmCAD-UT Detection 2.2

FDA 510(k)

FDA Class 2 ·Radiology

CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GEM-TWIN TENS/ MODELS GM3XY/Z

FDA 510(k)

FDA Class 2 ·Neurology

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43

FDA 510(k)

FDA Class 2 ·Cardiovascular