ANI BIOCARD(TM) HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

COSMED K5 Wearable Metabolic Technology

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

electrocardiograph: SE-1202

FDA 510(k)

FDA Class 2 ·Cardiovascular

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

3M QUIKPLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CONTATTO CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

Medical Disposable Sterile Needle Electrode

FDA 510(k)

FDA Class 2 ·Neurology

PERSONAL/DERBY CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BV Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

FDA 510(k)

FDA Class 2 ·Cardiovascular