American Medical Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Apr 22, 2004

AMS APOGEE VAULT SUSPENSION SYSTEM

K040537 · OTP

Obstetrics & Gynecology · 51d

Cleared Mar 24, 2004

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH

K040521 · OTP

Obstetrics & Gynecology · 23d

Cleared Mar 17, 2004

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

K040538 · OTN

Gastroenterology & Urology · 15d

Cleared Dec 31, 2003

AMS LARGE PORE POLYPROPYLENE MESH

K033636 · OTP

Obstetrics & Gynecology · 42d

Cleared Feb 06, 2003

BIOARC SP SLING KIT

K030123 · OTN

Gastroenterology & Urology · 23d

Cleared Nov 19, 2002

MONARC SLING SYSTEM

K023516 · OTN

Gastroenterology & Urology · 29d

Cleared May 15, 2002

MODIFICATION TO SPARC SLING SYSTEM

K021263 · OTN

Gastroenterology & Urology · 23d

Cleared Mar 28, 2002

MODIFICATION TO SPARC SLING SYSTEM

K020663 · OTN

Gastroenterology & Urology · 27d

Cleared Mar 13, 2002

MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM

K020446 · HWC

General & Plastic Surgery · 30d

Cleared Oct 26, 2001

SPARC SLING SYSTEM

K013355 · OTN

Gastroenterology & Urology · 16d

Cleared Sep 05, 2001

AMS SOFT-TISSUE APPROXIMATION SYSTEM

K012342 · FZP

General & Plastic Surgery · 43d

Cleared Aug 01, 2001

SPARC SLING SYSTEM

K011251 · OTN

Gastroenterology & Urology · 99d

Cleared Jul 13, 2001

IN-FAST BONE SCREW SYSTEM

K011910 · HWC

Orthopedic · 24d

Cleared Jun 22, 2001

AMS SLING FIXATION SYSTEM

K010990 · GAW

General & Plastic Surgery · 80d

Cleared Apr 09, 2001

AMS SACRAL COLPOPEXY SLING, MODEL 72403501

K010931 · OTO

Obstetrics & Gynecology · 12d

Cleared Mar 26, 2001

AMS FASCIAL-ANCHORING SYSTEM

K010277 · NEH

General & Plastic Surgery · 55d

Cleared Nov 29, 2000

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH

K002721 · FTL

General & Plastic Surgery · 90d

Cleared Mar 01, 2000

STAPLETAC2 BONE ANCHOR SYSTEM

K000279 · MBI

Orthopedic · 30d

Cleared Jun 29, 1999

COAGULOOP

K991314 · FAS

Gastroenterology & Urology · 74d

Cleared Aug 29, 1997

AMS FOREIGN BODY EXTRATOR

K972091 · FFL

Gastroenterology & Urology · 86d

Cleared Jul 24, 1997

AMS COAGULOOP RESECTION ELECTRODE

K971512 · FAS

Gastroenterology & Urology · 87d

Cleared Jul 09, 1997

AMS MAINSTAY UROLOGIC BONE ANCHOR

K971332 · MBI

Orthopedic · 90d

Cleared Dec 04, 1996

AMS AMBICOR PENILE PROSTHESIS

K963328 · FAE

Gastroenterology & Urology · 103d

Cleared Jul 06, 1995

AMS 650 MALLERABLE PENIEL PROSTHESIS

K951716 · FAE

Gastroenterology & Urology · 83d

Cleared Aug 19, 1994

ENTRAC URETERAL BALLOON DILATATION CATHETERS

K942578 · EZN

Gastroenterology & Urology · 80d