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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

bellavista 1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

VADER® Pedicle System and VADER®one Pedicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bellavista

FDA 510(k)

FDA Class 2 ·Anesthesiology

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Twoplus Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ProSeal™ Injection Site Extended Male Luer Lock (422140)

FDA 510(k)

FDA Class 2 ·General Hospital

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

FDA 510(k)

FDA Class 2 ·General Hospital

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEXTROSCOPE & DEXTROBEAM

FDA 510(k)

FDA Class 2 ·Radiology

SurgiLance® Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hushd Pro Avera

FDA 510(k)

FDA Class 2 ·Dental

ANT-X System

FDA 510(k)

FDA Class 2 ·Radiology

Silicone Foley Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

FDA 510(k)

FDA Class 2 ·General Hospital

Blood Collection Accessory (BUCA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

FDA 510(k)

FDA Class 2 ·Radiology

AeviceMD

FDA 510(k)

FDA Class 2 ·Cardiovascular