Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oral Matrix

FDA 510(k)

FDA Class 2 ·Dental

Disposable Laparoscope Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Diode Laser Hair Removal System (MBT-Diode Laser)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

Disposable Specimen Retrieval Bag

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

FDA 510(k)

FDA Class 2 ·Radiology

HAYMAX

FDA 510(k)

FDA Class 2 ·General Hospital

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PROTEX, TAHITI CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

extriCARE® 3000 Negative Wound Pressure Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Air Next

FDA 510(k)

FDA Class 2 ·Anesthesiology

RANEY CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

MODULOCK POSTERIOR SPINAL FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic