HEARTTRENDS

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXV VENOUS RESERVOIR BAG & HOLDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EASI-LAV ADULT GASTRIC LAVAGE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIV BREAST SELF EXAMINATION AID

FDA 510(k)

FDA Class 2 ·Radiology

CONICAL CONNECTION IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

FORMOSTAR

FDA 510(k)

FDA Class 2 ·Physical Medicine

LIV MEDICA CPR FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

i-CAT FLX V series / KaVo 3D eXam+ V series

FDA 510(k)

FDA Class 2 ·Radiology

URESIL SPECIMEN RETRIEVAL BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URESIL VALVE CUTTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

URESIL FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Koios DS for Breast

FDA 510(k)

FDA Class 2 ·Radiology