AMS 650 MALLERABLE PENIEL PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOARC SP SLING KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONARC SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

120 FR OPTILUME PROSTATE BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS OPTILUME INFLATION SYRINGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETERAL STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS OPTILUME(TM) PROSTATE BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTRAC(TM) URETHRAL MEASURING CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS SLING FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMS SMART SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMS COAGULOOP RESECTION ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE INFLATABLE PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPARC SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMS SOFT-TISSUE APPROXIMATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE ARTIFICIAL URINARY SPHINCTER

FDA 510(k)

FDA Class 3 ·Unknown

ENTRAC URETHRAL BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology