FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

72 results for "American Medical Systems, Inc."
25–48 of 72
Search insights Median review: 69d Cleared: 100% Top manufacturer: American Medical Systems, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 17, 2004
AMS PERIGEE SYSTEM
K040623 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 51d
Cleared Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 23d
Cleared Mar 17, 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
K033636 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared Feb 06, 2003
BIOARC SP SLING KIT
K030123 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared Nov 19, 2002
MONARC SLING SYSTEM
K023516 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · HWC
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Oct 26, 2001
SPARC SLING SYSTEM
K013355 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Sep 05, 2001
AMS SOFT-TISSUE APPROXIMATION SYSTEM
K012342 · FZP
American Medical Systems, Inc.
General & Plastic Surgery · 43d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jun 22, 2001
AMS SLING FIXATION SYSTEM
K010990 · GAW
American Medical Systems, Inc.
General & Plastic Surgery · 80d
Cleared Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · OTO
American Medical Systems, Inc.
Obstetrics & Gynecology · 12d
Cleared Mar 26, 2001
AMS FASCIAL-ANCHORING SYSTEM
K010277 · NEH
American Medical Systems, Inc.
General & Plastic Surgery · 55d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · MBI
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Jun 29, 1999
COAGULOOP
K991314 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 74d
Cleared Aug 29, 1997
AMS FOREIGN BODY EXTRATOR
K972091 · FFL
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 24, 1997
AMS COAGULOOP RESECTION ELECTRODE
K971512 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Dec 04, 1996
AMS AMBICOR PENILE PROSTHESIS
K963328 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 103d